Trial Outcomes & Findings for Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease (NCT NCT04906707)

NCT ID: NCT04906707

Last Updated: 2025-04-20

Results Overview

For daily measures, self-reported pain ratings will be assessed with the Numerical Pain Rating Scale (NPRS). On the NPRS, pain intensity levels range from 0 to 10 (0 = no pain and 10 = worst pain). Lower pain ratings correlate with better outcome. Daily Pain Diary responses were intermittent and can only be aggregated during time period 1 (days 1-28) and time period 2 (days 29-56). Diaries were not administered at day 0.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Baseline, up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
• Results posted on: 2025-04-20

Participant Flow

Participant milestones

Measure	EaseVRx Group Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Overall Study STARTED	19	25
Overall Study COMPLETED	16	24
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	EaseVRx Group Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Overall Study Withdrawal by Subject	2	0
Overall Study Withdrawal due to PI decision	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease

Baseline characteristics by cohort

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.	Total n=44 Participants Total of all reporting groups
Age, Continuous	36.37 years STANDARD_DEVIATION 6.67 • n=93 Participants	31.72 years STANDARD_DEVIATION 7.61 • n=4 Participants	33.73 years STANDARD_DEVIATION 7.50 • n=27 Participants
Sex/Gender, Customized Female	12 Participants n=93 Participants	15 Participants n=4 Participants	27 Participants n=27 Participants
Sex/Gender, Customized Male	7 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants
Sex/Gender, Customized Transgender Male	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants	23 Participants n=4 Participants	42 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	17 Participants n=93 Participants	24 Participants n=4 Participants	41 Participants n=27 Participants
Race/Ethnicity, Customized White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	25 participants n=4 Participants	44 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint

For daily measures, self-reported pain ratings will be assessed with the Numerical Pain Rating Scale (NPRS). On the NPRS, pain intensity levels range from 0 to 10 (0 = no pain and 10 = worst pain). Lower pain ratings correlate with better outcome.

Daily Pain Diary responses were intermittent and can only be aggregated during time period 1 (days 1-28) and time period 2 (days 29-56). Diaries were not administered at day 0.

Outcome measures

Measure	EaseVRx Group n=12 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=23 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Pain Rating Using Numerical Pain Rating Scale (NPRS) NPRS daily score at up to week 4 or time period 1 (day 1-28)	3.79 score on a scale Standard Deviation 2.93	3.17 score on a scale Standard Deviation 2.79
Pain Rating Using Numerical Pain Rating Scale (NPRS) NPRS daily score from week 4 to 8, or time period 2 (days 29-56)	2.37 score on a scale Standard Deviation 2.77	2.63 score on a scale Standard Deviation 2.78

PRIMARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

For baseline and monthly measurements, self-reported pain ratings were assessed with the Pain Intensity subscale of the Chronic Pain Grade Questionnaire. On the Chronic Pain Grade Questionnaire, pain intensity levels range from 0-100. Lower pain ratings correlate with better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Pain Intensity Subscale of the Chronic Pain Grade Questionnaire Pain Intensity score at Baseline	66.84 score on a scale Standard Deviation 12.64	63.07 score on a scale Standard Deviation 15.84
Pain Intensity Subscale of the Chronic Pain Grade Questionnaire Pain Intensity score at 4 weeks	60.28 score on a scale Standard Deviation 13.06	54.06 score on a scale Standard Deviation 16.24
Pain Intensity Subscale of the Chronic Pain Grade Questionnaire Pain Intensity score at 8 weeks	56.33 score on a scale Standard Deviation 13.65	48.84 score on a scale Standard Deviation 17.68
Pain Intensity Subscale of the Chronic Pain Grade Questionnaire Pain Intensity score at 12 weeks	60.00 score on a scale Standard Deviation 14.05	45.96 score on a scale Standard Deviation 20.54

PRIMARY outcome

Timeframe: up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint

Minutes of daily program use may range from 2 minutes to 48 minutes or more. The investigator hypothesizes that higher usage will correlate with a better outcome.

Because of intermittent usage patterns, self-reported program use was aggregated during time period 1 (days 1-28) and time period 2 (days 29-56).

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=24 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Participant Engagement: Minutes of Program Use Per Day Time period 1 (days 1-28)	170.5 Minutes of Program Use Per Day Interval 18.75 to 314.0	128.5 Minutes of Program Use Per Day Interval 56.25 to 197.44
Participant Engagement: Minutes of Program Use Per Day Time period 2 (days 29-56)	243.0 Minutes of Program Use Per Day Interval 18.75 to 477.5	163.25 Minutes of Program Use Per Day Interval 66.25 to 315.85

PRIMARY outcome

Timeframe: Baseline, daily during treatment (4 weeks or time period 1, day 1-28), daily during treatment (8 weeks or time period 2, days 29-56)

Population: Lack of granularity in the VR device usage data (data provided monthly, not daily) limits the ability to identify specific usage patterns for reporting regarding duration in minutes each week. However, usage duration was self-reported by the VR group and the audio group. Participants who completed the corresponding survey for this outcome are included per timepoint.

Throughout the 8-week treatment period, device usage duration may range from 0 to 7 days each week. The investigator hypothesizes that higher usage will correlate with a better outcome.

Outcome measures

Measure	EaseVRx Group n=18 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=23 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Participant Engagement: Duration in Days Time period 1 (days 1-28)	1.38 days Interval 0.25 to 3.33	2.75 days Interval 1.5 to 5.3
Participant Engagement: Duration in Days Time period 2 (days 29-56)	1.63 days Interval 0.2 to 4.2	2.13 days Interval 0.95 to 4.13

PRIMARY outcome

Timeframe: Daily during treatment (8 weeks)

Population: Lack of granularity in the VR usage data limits the ability to identify specific usage patterns. Therefore, the average number of features utilized can only be reported across the 8 weeks of treatment. Participants who completed the corresponding survey for this outcome are included per timepoint. This outcome was not applicable to the Audio group.

Assessed by the number of features utilized when using the VRdevice. The number of features utilized may be 1 or 2 . The investigator hypothesizes that use of a higher number of features will correlate with a better outcome.

Outcome measures

Measure	EaseVRx Group n=17 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Participant Engagement: Features Utilized Number of participants with 1 feature utilized	6 Participants	—
Participant Engagement: Features Utilized Number of participants with 2 features utilized	11 Participants	—

PRIMARY outcome

Timeframe: Daily average during treatment (up to 8 weeks)

Population: Because of intermittent usage patterns, the average number of modules completed weekly could not be assessed for the Audio group (Active control group). Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by completion rates: the number of modules completed weekly. Rates may range from 0 to 7 modules completed each week. The investigator hypothesizes that completion of a higher number of modules weekly will correlate with a better outcome.

Outcome measures

Measure	EaseVRx Group n=16 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Participant Engagement: Completion Rates	2.38 modules/week Interval 0.44 to 5.01	—

PRIMARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by participant completion of survey measures at repeated timepoints (baseline, week 4, week 8, and week 12). The investigator hypothesizes that higher study retention will correlate with a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Study Retention: Surveys 4 weeks	12 surveys completed	23 surveys completed
Study Retention: Surveys 8 weeks	10 surveys completed	23 surveys completed
Study Retention: Surveys Baseline	19 surveys completed	25 surveys completed
Study Retention: Surveys 4 weeks post-intervention (week 12)	10 surveys completed	19 surveys completed

PRIMARY outcome

Timeframe: Up to 8 weeks

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by participant completion of daily diaries across 8 weeks of treatment (days 1-56). The investigator hypothesizes that higher study retention will correlate with a better outcome.

Outcome measures

Measure	EaseVRx Group n=18 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=24 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Study Retention: Daily Diaries	28 daily diaries	32 daily diaries

PRIMARY outcome

Timeframe: Post-treatment (up to 6 weeks post-treatment)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed, once at the end of the program, via individual qualitative interviews or focus group sessions. Participants will be asked to evaluate the program by responding to the four items listed below, using a Likert scale (strongly agree, somewhat agree, somewhat disagree, strongly disagree with possible score range 1-4) for the first three items and 1-10 (with 10 being definitely would recommend) for the fourth item.• The VR program was easy to use.• I enjoyed using the VR program.• The content in the VR program helped me cope with my pain.• On a scale of 1-10, how likely are you to recommend the VR program to someone else at this time? The investigator hypothesizes that responses of strongly agree and higher scores will correlate with a better outcome.

Outcome measures

Measure	EaseVRx Group n=8 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=16 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Participant Satisfaction The program was easy to use (Scale of 1-4)	4.0 score on a scale Interval 3.0 to 4.0	4.0 score on a scale Interval 3.0 to 4.0
Participant Satisfaction I enjoyed using the program (Scale of 1-4)	4.0 score on a scale Interval 3.0 to 4.0	4.0 score on a scale Interval 3.0 to 4.0
Participant Satisfaction The content in the program helped me cope with my pain (Scale of 1-4)	4.0 score on a scale Interval 3.0 to 4.0	4.0 score on a scale Interval 3.0 to 4.0
Participant Satisfaction On a scale of 1-10, how likely are you to recommend the program to someone else at this time?	10.0 score on a scale Interval 7.0 to 10.0	10.0 score on a scale Interval 8.0 to 10.0

PRIMARY outcome

Timeframe: Post-treatment (up to 6 weeks post-treatment)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed once at the end of the program, via individual qualitative interviews or focus group sessions.

Participants choosing the highest score for each of the four items listed will be counted.

Higher number correlates with a better outcome.

Outcome measures

Measure	EaseVRx Group n=8 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=16 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Frequency of Highest Satisfaction Scores Participants with highest score for "The program was easy to use"	7 Participants	14 Participants
Frequency of Highest Satisfaction Scores Participants with highest score for "I enjoyed using the program"	6 Participants	13 Participants
Frequency of Highest Satisfaction Scores Participants with highest score for "The content in the program helped me cope with my pain"	6 Participants	12 Participants
Frequency of Highest Satisfaction Scores Participants with highest score for "how likely you to recommend the program to someone else?"	5 Participants	9 Participants

PRIMARY outcome

Timeframe: 4 weeks, 8 weeks, up to 6 weeks post-treatment

Population: This outcome was only assessed in the EaseVRx Group because it was not applicable to the Audio group .Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by monitoring participants for the number of adverse events. Fewer adverse events correlate with a better outcome.

Outcome measures

Measure	EaseVRx Group n=16 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Safety: Number of Adverse Events Number of Adverse events at 4 weeks	2 adverse events	—
Safety: Number of Adverse Events Number of Adverse events at 8 weeks	0 adverse events	—
Safety: Number of Adverse Events Number of adverse events at up to 6 weeks post-treatment	0 adverse events	—

SECONDARY outcome

Timeframe: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by the Chronic Pain Acceptance Questionnaire (CPAQ-8) which measures acceptance of chronic pain. Items are scored on a scale from 0 to 6 (never true to always true), and higher scores (total possible scores range from 0 to 48) indicate higher levels of acceptance (better outcome).

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Chronic Pain Acceptance Score Baseline	24.00 score on a scale Standard Deviation 7.83	21.40 score on a scale Standard Deviation 5.97
Chronic Pain Acceptance Score Week 4	26.45 score on a scale Standard Deviation 6.99	23.43 score on a scale Standard Deviation 4.80
Chronic Pain Acceptance Score Week 8	28.20 score on a scale Standard Deviation 5.90	23.65 score on a scale Standard Deviation 6.73
Chronic Pain Acceptance Score Week 12	28.30 score on a scale Standard Deviation 5.02	25.26 score on a scale Standard Deviation 3.45

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Chronic Pain Self-Efficacy Scale (CPSES), which measures efficacy expectations for coping with the consequences of chronic pain. Items are scored on a 10-point Likert-type scale from 1 (very uncertain) to 10 (very certain), with a minimum total score of 22 and a maximum total score of 220. Higher scores indicate a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Chronic Pain Self-Efficacy Baseline	154.68 score on a scale Standard Deviation 27.70	155.92 score on a scale Standard Deviation 32.60
Chronic Pain Self-Efficacy Week 4	155.82 score on a scale Standard Deviation 42.36	151.52 score on a scale Standard Deviation 35.25
Chronic Pain Self-Efficacy Week 8	166.40 score on a scale Standard Deviation 31.01	148.13 score on a scale Standard Deviation 42.82
Chronic Pain Self-Efficacy Week 12	162.60 score on a scale Standard Deviation 24.93	160.89 score on a scale Standard Deviation 39.33

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Social Support Questionnaire (SSQ), which measures perceptions of the desirability, availability, use, and usefulness of social support. Items are scored on a scale from 1 (not at all) to 5 (very much, constantly), with a minimum total score of 32 and a maximum total score of 160. Higher scores indicate a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Social Support Baseline SSQ score	111.95 score on a scale Standard Deviation 23.81	123.48 score on a scale Standard Deviation 24.57
Social Support Week 4 SSQ score	116.55 score on a scale Standard Deviation 27.26	129.48 score on a scale Standard Deviation 18.78
Social Support Week 8 SSQ score	115.50 score on a scale Standard Deviation 33.37	121.52 score on a scale Standard Deviation 22.78
Social Support Week 12 SSQ score	121.90 score on a scale Standard Deviation 19.94	131.89 score on a scale Standard Deviation 23.02

SECONDARY outcome

Timeframe: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Pain Catastrophizing Scale (PCS-13) which measures thoughts and feelings when pain is experienced. Items are scored on a scale from 0 to 4 (not at all to all the time), and higher scores (scores range from 0 to 52) indicate a higher degree of catastrophizing (worse outcome).

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Pain Catastrophizing Score Baseline	22.74 score on a scale Standard Deviation 14.80	25.48 score on a scale Standard Deviation 10.78
Pain Catastrophizing Score Week 4	18.82 score on a scale Standard Deviation 8.20	21.91 score on a scale Standard Deviation 11.80
Pain Catastrophizing Score Week 8	14.30 score on a scale Standard Deviation 7.10	19.26 score on a scale Standard Deviation 9.63
Pain Catastrophizing Score Week 12	14.50 score on a scale Standard Deviation 5.80	18.00 score on a scale Standard Deviation 11.35

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the BRIEF Health Literacy Screening Tool which measures the amount of help needed in healthcare situations. Items are scored on a scale from 1 to 5 (always to never and not at all to extremely), and higher total scores (scores range from 4 to 20) indicate greater health literacy (better outcome).

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
BRIEF Health Literacy Score Baseline	19.05 score on a scale Standard Deviation 1.39	18.24 score on a scale Standard Deviation 2.33
BRIEF Health Literacy Score Week 4	19.00 score on a scale Standard Deviation 1.79	17.65 score on a scale Standard Deviation 3.01
BRIEF Health Literacy Score Week 8	18.60 score on a scale Standard Deviation 2.37	17.04 score on a scale Standard Deviation 3.01
BRIEF Health Literacy Score Week 12	19.00 score on a scale Standard Deviation 1.89	17.84 score on a scale Standard Deviation 2.99

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Behavior Rating Inventory of Executive Function (BRIEF-A) which measures adult executive functioning/self-regulation. Items are scored on a scale from 1 to 7 (never a problem to always a problem) and higher total scores (scores range from 34 to 238) indicate more symptoms of executive dysfunction (worse outcome).

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Executive Function BRIEF-A score at Week 8	79.00 score on a scale Standard Deviation 25.83	92.43 score on a scale Standard Deviation 28.80
Executive Function Baseline BRIEF-A score	78.53 score on a scale Standard Deviation 24.02	98.12 score on a scale Standard Deviation 28.50
Executive Function BRIEF-A score at Week 4	76.27 score on a scale Standard Deviation 26.41	83.00 score on a scale Standard Deviation 25.71
Executive Function BRIEF-A score at Week 12	75.90 score on a scale Standard Deviation 17.65	79.74 score on a scale Standard Deviation 28.17

SECONDARY outcome

Timeframe: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using PROMIS Emotional Distress - Anxiety (Anxiety 8a - Adult v1.0), which measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. Items are scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) and the total raw score (minimum total score of 8 and maximum total score of 40) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 37.1 and a maximum total score of 83.1, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Anxiety Levels Baseline	53.19 T-score Standard Deviation 9.33	57.38 T-score Standard Deviation 8.43
Anxiety Levels Week 4	52.65 T-score Standard Deviation 10.21	56.74 T-score Standard Deviation 9.70
Anxiety Levels Week 8	47.72 T-score Standard Deviation 8.45	54.65 T-score Standard Deviation 8.85
Anxiety Levels Week 12	50.03 T-score Standard Deviation 11.14	52.56 T-score Standard Deviation 10.83

SECONDARY outcome

Timeframe: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using PROMIS Emotional Distress - Depression (Depression 8a - Adult v1.0), which measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Items are scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) and the total raw score (minimum total score of 8 and maximum total score of 40) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 38.2 and a maximum total score of 81.3, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Depression Levels Baseline	48.96 T-score Standard Deviation 8.66	55.60 T-score Standard Deviation 10.03
Depression Levels Week 4	48.59 T-score Standard Deviation 7.78	53.50 T-score Standard Deviation 9.97
Depression Levels Week 8	45.99 T-score Standard Deviation 9.71	52.94 T-score Standard Deviation 8.81
Depression Levels Week 12	45.05 T-score Standard Deviation 8.71	49.15 T-score Standard Deviation 9.56

SECONDARY outcome

Timeframe: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Sleep Impact Short Form, which measures sleep disturbances. 5 items are assessed using a scale that ranges from 1 (never or always) to 5 (never or always) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 27.9 and a maximum total score of 69.1, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Sleep Impact Short Form Score Baseline	49.03 T-score Standard Deviation 7.04	49.92 T-score Standard Deviation 5.48
Sleep Impact Short Form Score Week 4	49.75 T-score Standard Deviation 7.56	50.65 T-score Standard Deviation 6.20
Sleep Impact Short Form Score Week 8	52.91 T-score Standard Deviation 5.68	51.64 T-score Standard Deviation 5.91
Sleep Impact Short Form Score Week 12	55.37 T-score Standard Deviation 6.15	51.88 T-score Standard Deviation 7.17

SECONDARY outcome

Timeframe: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Impact Short Form, which measures the effects of sickle cell pain on activities of daily living. 5 items are assessed using a scale that ranges from 1 (always) to 5 (never) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 24.8 and a maximum total score of 63.8, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Functional Activities of Daily Living Baseline	49.65 T-score Standard Deviation 6.39	47.81 T-score Standard Deviation 6.68
Functional Activities of Daily Living Week 4	51.77 T-score Standard Deviation 7.07	47.30 T-score Standard Deviation 6.66
Functional Activities of Daily Living Week 8	51.54 T-score Standard Deviation 6.86	48.06 T-score Standard Deviation 8.43
Functional Activities of Daily Living Week 12	52.59 T-score Standard Deviation 8.62	49.44 T-score Standard Deviation 9.78

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by the Chronic Pain Grade Questionnaire (CPGQ) which classifies individuals into one of four categories according to pain severity or interference. Items are scored on a scale from 0 to 10, with total scores for chronic pain intensity and chronic pain disability ranging from 0 to 100. Higher total scores indicate a higher level of disability that is severely limiting (worse outcome).

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Chronic Pain Disability Score Baseline	56.14 score on a scale Standard Deviation 26.42	54.67 score on a scale Standard Deviation 24.29
Chronic Pain Disability Score Week 4	48.06 score on a scale Standard Deviation 21.67	51.01 score on a scale Standard Deviation 20.68
Chronic Pain Disability Score Week 8	39.33 score on a scale Standard Deviation 17.90	44.20 score on a scale Standard Deviation 17.06
Chronic Pain Disability Score Week 12	43.00 score on a scale Standard Deviation 14.61	42.81 score on a scale Standard Deviation 27.45

SECONDARY outcome

Timeframe: Baseline

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by healthcare utilization for pain in the previous 12 months as reflected by self-reported number of healthcare visits. The number of healthcare visits may range from 0 to 20 or more. A higher number of visits is correlated with worse outcome.

Outcome measures

Measure	EaseVRx Group n=22 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Average Healthcare Utilization	2.5 healthcare visits Interval 0.0 to 5.0	2.0 healthcare visits Interval 1.0 to 5.5

SECONDARY outcome

Timeframe: Time period 1 (days 1-28) and time period 2 (days 29-56)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by self-reported number of over-the-counter analgesics used per day via the Daily Pain Diary. Results will be reported during time period 1 (days 1-28) and time period 2 (days 29-56). A higher number of pain medications correlates with a worse outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Number of Analgesics Time period 1 (days 1-28)	4.88 analgesics/day Standard Deviation 3.35	3.80 analgesics/day Standard Deviation 3.01
Number of Analgesics Time period 2 (days 29-56)	4.86 analgesics/day Standard Deviation 2.18	4.69 analgesics/day Standard Deviation 3.64

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episodes Short Form, which measures the frequency and severity of sickle cell pain episodes. 2 items are assessed using a scale that varies across the items, with values ranging from 0-4 or 0-7, and the total raw score (minimum total score of 0 and maximum total score of 11) is rescaled into a standardized T-score. The standardized T-score has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Quality of Life: Frequency of Sickle Cell Pain Episodes Baseline	51.85 T-score Standard Deviation 8.39	47.65 T-score Standard Deviation 8.97
Quality of Life: Frequency of Sickle Cell Pain Episodes Week 4	50.08 T-score Standard Deviation 8.22	46.27 T-score Standard Deviation 11.88
Quality of Life: Frequency of Sickle Cell Pain Episodes Week 8	48.74 T-score Standard Deviation 10.81	45.93 T-score Standard Deviation 12.83
Quality of Life: Frequency of Sickle Cell Pain Episodes Week 12	47.96 T-score Standard Deviation 9.69	42.23 T-score Standard Deviation 12.58

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episodes Short Form, which measures the frequency and severity of sickle cell pain episodes. 3 items are assessed using a scale that varies across the items, with values ranging from 0-7, 0-5, or 0-10, and the total raw score (minimum total score of 0 and maximum total score of 22) is rescaled into a standardized T-score. The standardized T-score has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a worse outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Quality of Life: Severity of Sickle Cell Pain Episodes Baseline	52.79 T-score Standard Deviation 7.66	45.84 T-score Standard Deviation 7.99
Quality of Life: Severity of Sickle Cell Pain Episodes Week 4	49.32 T-score Standard Deviation 10.36	46.19 T-score Standard Deviation 9.72
Quality of Life: Severity of Sickle Cell Pain Episodes Week 8	50.42 T-score Standard Deviation 9.01	44.87 T-score Standard Deviation 10.94
Quality of Life: Severity of Sickle Cell Pain Episodes Week 12	48.55 T-score Standard Deviation 6.06	44.54 T-score Standard Deviation 8.51

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Emotional Impact Short Form, which measures the effects of sickle cell on emotional well-being. 5 items are assessed using a scale that ranges from 1 (always or very much) to 5 (never or not at all) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 26.8 and a maximum total score of 65.6, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Quality of Life: Emotional Impact Baseline	51.70 T-score Standard Deviation 7.80	49.21 T-score Standard Deviation 6.45
Quality of Life: Emotional Impact Week 4	54.56 T-score Standard Deviation 8.54	52.57 T-score Standard Deviation 8.57
Quality of Life: Emotional Impact Week 8	55.13 T-score Standard Deviation 8.66	51.53 T-score Standard Deviation 8.98
Quality of Life: Emotional Impact Week 12	54.06 T-score Standard Deviation 6.92	52.84 T-score Standard Deviation 8.66

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Social Functioning Short Form, which measures the influence of health on social functioning. 5 items are assessed using a scale that ranges from 1 (very much or always) to 5 (not at all or never) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 26 and a maximum total score of 69.8, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Quality of Life: Social Functioning Baseline	49.48 T-score Standard Deviation 10.52	51.43 T-score Standard Deviation 8.11
Quality of Life: Social Functioning Week 4	56.04 T-score Standard Deviation 4.56	50.33 T-score Standard Deviation 8.08
Quality of Life: Social Functioning Week 8	53.50 T-score Standard Deviation 8.34	51.92 T-score Standard Deviation 8.94
Quality of Life: Social Functioning Week 12	57.82 T-score Standard Deviation 5.97	53.97 T-score Standard Deviation 10.58

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)

Population: Participants who completed the corresponding survey for this outcome are included per timepoint.

Assessed by using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Stiffness Impact Short Form, which measures joint/body stiffness. 5 items are assessed using a scale that ranges from 1 (always) to 5 (never) and the total raw score (minimum total score of 5 and maximum total score of 25) is rescaled into a standardized T-score. The standardized T-score, with a minimum total score of 24.9 and a maximum total score of 65.4, has a mean of 50 and a standard deviation of 10. Higher T-scores indicate a better outcome.

Outcome measures

Measure	EaseVRx Group n=19 Participants Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 Participants Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Quality of Life: Stiffness Impact Baseline	47.73 T-score Standard Deviation 6.62	45.78 T-score Standard Deviation 7.63
Quality of Life: Stiffness Impact Week 4	52.20 T-score Standard Deviation 7.21	46.58 T-score Standard Deviation 6.13
Quality of Life: Stiffness Impact Week 8	52.02 T-score Standard Deviation 7.76	47.06 T-score Standard Deviation 6.94
Quality of Life: Stiffness Impact Week 12	54.78 T-score Standard Deviation 9.23	50.48 T-score Standard Deviation 7.56

Adverse Events

EaseVRx Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Active Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EaseVRx Group n=19 participants at risk Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. EaseVRx: EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.	Active Control Group n=25 participants at risk Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. Audio-only version of EaseVRx: Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • 12 weeks The study involved a low-risk behavioral intervention for adults with SCD. An adverse event (AE) was considered as any event meeting the following definition: "Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research."	0.00% 0/25 • 12 weeks The study involved a low-risk behavioral intervention for adults with SCD. An adverse event (AE) was considered as any event meeting the following definition: "Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research."
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • 12 weeks The study involved a low-risk behavioral intervention for adults with SCD. An adverse event (AE) was considered as any event meeting the following definition: "Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research."	0.00% 0/25 • 12 weeks The study involved a low-risk behavioral intervention for adults with SCD. An adverse event (AE) was considered as any event meeting the following definition: "Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research."

Additional Information

Dr. Nadine Matthie

Emory University

Phone: 404-712-8449

Email: nadine.matthie@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place