Trial Outcomes & Findings for Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot (NCT NCT05546749)

Results Overview

Change in Pain Intensity from baseline was assessed using the single items Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity scale. Patients were asked to assess their average pain over the past 7 days on an 11-point Likert scale ranging from 0-10 where 0 = no pain and 10 = worst pain imaginable. Positive mean scores were associated with increased pain intensity from baseline and negative mean scores were associated with decreased pain intensity from baseline. Scores were summarized by study arm using basic descriptive statistics.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

From baseline to 6 weeks

Results posted on

2025-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	RelieVRx RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Overall Study STARTED	10	8
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality for Chronic Pain and Opioid Use Disorder Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RelieVRx n=10 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=8 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.	Total n=18 Participants Total of all reporting groups
Age, Continuous	59.5 years STANDARD_DEVIATION 5.3 • n=5 Participants	60.3 years STANDARD_DEVIATION 8.0 • n=7 Participants	59.8 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black, non Hispanic	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic, any race	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	8 participants n=7 Participants	18 participants n=5 Participants
Education Did not complete High School (HS)	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Education Completed GED or equivalent	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Education Received HS diploma	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Education Completed 1 or more years of college/university	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Pain impact (PEG score)	7.67 score on a scale STANDARD_DEVIATION 1.67 • n=5 Participants	6.71 score on a scale STANDARD_DEVIATION 1.86 • n=7 Participants	7.24 score on a scale STANDARD_DEVIATION 1.78 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 6 weeks

Population: 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in Pain Intensity from baseline was assessed using the single items Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity scale. Patients were asked to assess their average pain over the past 7 days on an 11-point Likert scale ranging from 0-10 where 0 = no pain and 10 = worst pain imaginable. Positive mean scores were associated with increased pain intensity from baseline and negative mean scores were associated with decreased pain intensity from baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Pain Intensity	-1.38 score on a scale Standard Deviation 1.69	0.33 score on a scale Standard Deviation 2.66

PRIMARY outcome

Timeframe: From baseline to 6 weeks

Population: 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in Opioid Craving was assessed using the Opioid Medication Craving Visual Analog Scale. This 3-item scale asked participants to rate how strong their desire to use opioids was during the previous 24 hours; the likelihood that they would use opioids if placed in the environment in which they had previously used drugs/alcohol; and how strong their urges for opioids are when something in their environment reminds them of it. Responses were marked on visual scale ranging from 0-100 where "0" signified 'No Desire or Likelihood of Use' and "100" signified 'Strong Desire or Likelihood of use. Positive mean scores were associated with increased opioid craving from baseline and negative mean scores were associated with decreased opioid craving from baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Opioid Craving	-2.86 score on a scale Standard Deviation 30.9	9.17 score on a scale Standard Deviation 17.44

PRIMARY outcome

Timeframe: Baseline, up to 2 weeks

Population: All participants who were contacted enrolled into the study.

The percentage of participants contacted who were enrolled into the study was used to assess the feasibility of the study. Results were summarized using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=10 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=8 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Percentage of Participants Contacted That Are Enrolled	10 Participants	8 Participants

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Pain Interference (PROMIS, Pain Interference 4a) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in pain interference was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 4a scale. This form consists of 4 items which asked participants to rate the degree to which their pain interfered with a range of activities over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from "Not at all" = 0 to "Very much" = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with greater pain interference. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater pain interference relative to baseline and negative mean scores were associated with reduced pain interference relative to baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Pain Interference	-2.25 score on a scale Standard Deviation 8.43	1.67 score on a scale Standard Deviation 5.20

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Sleep (PROMIS, Sleep Disturbance 6a) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in sleep was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 6a. This form consists of 6 items which asked participants to assess quality and attributes of their sleep patterns over the prior 7 days. Response options for the sleep quality item range from "Very poor" = 1 to "Very good = 5" and from "Not at all" = 1 to "Very much" = 5 for the remaining five items. The two positively phrased items are reverse-coded and sum scores are calculated and the raw sum score is rescaled on the PROMIS conversion table to determine a standardized T-score (overall mean of 50 and standard deviation of 10). For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater sleep disturbance and decreased overall sleep quality relative to baseline and negative mean scores were associated with decreased sleep disturbance and increased overall sleep quality relative to baseline.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Sleep	0 score on a scale Standard Deviation 8.52	3 score on a scale Standard Deviation 3.90

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Cognitive Function (PROMIS 29 Cognitive Function) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in cognitive function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS 29) Cognitive Function domain form. This form consists of 2 questions which asked participants to assess cognitive function over the prior 7 days. Both questions for this measure are summed up on a 5-point Likert scale ranging from "Not at all" to "Very much" = 4, for an overall possible scoring range of 0-8 such that higher scores are associated with increased overall cognitive function. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with increased overall cognitive function from baseline and negative mean scores were associated with decreased overall cognitive function from baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Cognitive Function	1.5 score on a scale Standard Deviation 3.25	-0.67 score on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Social Function (PROMIS, Social 4a Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in social function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social 4a Heal form. This form consists of 4 items which asked participants to assess their leisure, family, work and general social function behaviors over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from "Never" = 0 to "Always" = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with increased inhibition in social function/participation. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with decreased inhibition to social participation relative to baseline and negative mean scores were associated with increased inhibition to social participation relative to baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Social Function	2 score on a scale Standard Deviation 3.51	0.333 score on a scale Standard Deviation 3.44

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Physical Function (PROMIS, Social 6b Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in physical function was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social 6b Heal form. This form consists of 6 items which asked participants to assess their physical function and ability to conduct chores, climb stairs, walk, and run errands. Responses to the 6 items are summed up on a 5-point Likert scale ranging from "Without any difficulty" (or "Not at all") = 0 to "Unable to do" (or "Cannot do") = 4, for an overall possible scoring range of 0-24 such that higher scores are associated with increased inhibition in physical function. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with decreased inhibition in physical function relative to baseline and negative mean scores were associated with increased inhibition in physical function relative to baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Physical Function	1.13 score on a scale Standard Deviation 5.38	-1.83 score on a scale Standard Deviation 3.49

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Depression (PROMIS, Depression 4a Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in depression was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4a Heal form. This form consists of 4 items which asked participants to assess the frequency of depressive symptoms over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from "Never" = 0 to "Always" = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with a greater level of depression-related symptoms. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of depression-related symptoms relative to baseline and negative mean scores were associated with reduced frequency of depression-related symptoms relative to baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Depression	-2.38 score on a scale Standard Deviation 5.01	-2.5 score on a scale Standard Deviation 4.46

SECONDARY outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Anxiety (PROMIS, Anxiety 4a Heal) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in anxiety was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a Heal form. This form consists of 4 items which asked participants to assess the frequency of onset of anxiety-related symptoms over the prior 7 days. Responses to the 4 items are summed up on a 5-point Likert scale ranging from "Never" = 0 to "Always" = 4, for an overall possible scoring range of 0-16 such that higher scores are associated with a greater level of anxiety-related symptoms. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of anxiety symptoms relative to baseline and negative mean scores were associated with reduced frequency of anxiety symptoms relative to baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Anxiety	-2.88 score on a scale Standard Deviation 6.64	-1.0 score on a scale Standard Deviation 4.34

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 6 weeks

Population: 3-week Stress (NIH Perceived Stress Scale) data was not collected and, therefore, results were not available to be reported. 8 participants in the RelieVRx arm and 6 participants in the Sham Virtual Reality arm completed the study.

Change in stress was assessed using the National Institutes of Health (NIH) Perceived Stress Scale (PSS-10) which consists of 10 items asking participants to assess the frequency of onset of stress-related symptoms over the prior month on a 5-item Likert scale ranging from 0-4. Six of the ten items are coded such that "Never" = 0 and "Very often" = 4; and four of the ten items are reverse-coded such that "Never" =4 and "Very often" = 0, for an overall scoring range of 0-40. The higher the score the worse the perceived stress. For purposes of reporting of this change from baseline outcome measure, positive mean scores were associated with greater frequency of stress relative to baseline and negative mean scores were associated with reduced frequency of stress relative to baseline. Scores were summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	RelieVRx n=8 Participants RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=6 Participants The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Change in Stress	-4.13 score on a scale Standard Deviation 8.13	4.17 score on a scale Standard Deviation 15.70

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 weeks, 6 weeks

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RelieVRx n=10 participants at risk RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences. Participants in the intervention group will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. RelieVRx: The virtual reality device that will be piloted is called RelieVRx, which incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. RelieVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. RelieVRx was designed for at-home use and comes with a sequence of daily immersive experiences.	Sham Virtual Reality n=8 participants at risk The sham virtual reality (VR) device is also by RelieVRx. However, it lacks the immersive nature of the interventional VR. Control participants will complete 20-30 minute VR sessions twice per week over the course of 6 weeks. Sham VR: The sham VR control is a non-immersive set of 56 daily virtual experiences, tuned to the length of the RelieVRx.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • Approximately 6 weeks	0.00% 0/8 • Approximately 6 weeks

Additional Information

Hector Perez

Albert Einstein College of Medicine

Phone: 7189205756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place