Trial Outcomes & Findings for Virtual Reality for Outpatient Cancer Pain Management (NCT NCT05442866)

Last Updated: 2025-05-25

Results Overview

Participant reports average pain (Likert scale 0-10, 0=pain, 10=worst pain) over last 7 days; results report the average change in self-reported pain score per study week, from baseline (Study day 0) to each subsequent measurement (measured on Study day 7 (week 1), Study day 14 (week 2), Study day 21(week 3))

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

3 weeks (baseline to Study day 21)

Results posted on

2025-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality (VR) Dosing Arm All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Overall Study STARTED	33
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Virtual Reality (VR) Dosing Arm All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Overall Study Death	1
Overall Study Lost to Follow-up	9
Overall Study Protocol Violation	1

Baseline Characteristics

Virtual Reality for Outpatient Cancer Pain Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality (VR) Dosing Arm n=33 Participants All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks (baseline to Study day 21)

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Dosing Arm n=33 Participants All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Self-reported Pain Score	-0.3 score on a scale, measured each week Standard Error 0.1

SECONDARY outcome

Timeframe: 3 weeks (baseline to Study day 21)

Participant completes PROMIS measure of pain interference over last 7 days; PROMIS Pain Interference SF has 6 questions, each with possible scores 1 to 5, making a possible score range between 6 and 30 points - 30 points is the highest level of total pain interference, 6 points is the lowest level of total pain interference. These results report the average change in total Pain Interference SF score per study week, from baseline (Study day 0) to each subsequent measurement (measured on Study day 7 (week 1), Study day 14 (week 2), Study day 21(week 3))

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Dosing Arm n=33 Participants All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
PROMIS Pain Interference Short Form	-1.5 score on a scale, measured each week Standard Error 0.4

SECONDARY outcome

Timeframe: 3 weeks (baseline day 0 to Study day 21)

Population: Patients taking as needed opioids who completed all three study weeks

Participant reports how many as-needed opioid doses used in last 7 days (only for participants prescribed as-needed opioids); results report average number of as-needed opioid doses per day for each study week

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Dosing Arm n=16 Participants All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Number of As-needed Opioid Doses Per Day prn doses per day after Week 1	1.6 prn doses per day Standard Deviation 2.1
Number of As-needed Opioid Doses Per Day prn doses per day after Week 2	1.5 prn doses per day Standard Deviation 2.0
Number of As-needed Opioid Doses Per Day prn doses per day after Week 3	1.6 prn doses per day Standard Deviation 2.0

SECONDARY outcome

Timeframe: 3 weeks (baseline to Study day 21)

Participant reports satisfaction with pain management over last 7 days (Likert scale, 0=very unsatisfied, 10=highly satisfied); results report the average change in score of overall satisfaction in pain management per study week, from baseline (Study day 0) to each subsequent measurement (measured on Study day 7 (week 1), Study day 14 (week 2), Study day 21(week 3))

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Dosing Arm n=33 Participants All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Satisfaction With Overall Pain Management	0.7 score on a scale, measured each week Standard Error 0.2

SECONDARY outcome

Timeframe: 3 weeks (baseline to Study day 21)

Population: Patients who completed all three weeks of study completed this survey question

Participant reports satisfaction with virtual reality intervention over last 7 days (Likert scale, 0=very unsatisfied, 10=highly satisfied)

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Dosing Arm n=22 Participants All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Satisfaction With Virtual Reality Intervention Over Previous 7 Days	9.5 score on a scale Standard Error 2

SECONDARY outcome

Timeframe: Study day 21

Population: Participants who completed all three weeks of study period

Participant chooses preferred visual thematic content (as many as preferred) from photos of different images (e.g. beachscape, rain forest, luxury auto, monastery, etc.)

Outcome measures

Outcome measures
Measure	Virtual Reality (VR) Dosing Arm n=22 Participants All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Preferences for Virtual Reality Thematic Content (Measured Once, With no Comparison) Prefer realistic VR	14 Participants
Preferences for Virtual Reality Thematic Content (Measured Once, With no Comparison) Prefer simulated VR	7 Participants
Preferences for Virtual Reality Thematic Content (Measured Once, With no Comparison) Prefer both/mix	1 Participants

Adverse Events

Virtual Reality (VR) Dosing Arm

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Virtual Reality (VR) Dosing Arm n=33 participants at risk All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
Infections and infestations Hospitalized	3.0% 1/33 • Number of events 1 • Each participant was enrolled and followed by the study coordinator for a maximum period of 3 weeks (from enrollment and baseline measures to final measure collection). Because virtual reality has never been shown to have adverse events that last longer than the duration of the virtual reality device use, this time frame was most appropriate for adverse event data collection. Adverse events were first collected by the study coordinator during usual study processes and participant follow up and were each reviewed by the PI.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Surgery	3.0% 1/33 • Number of events 1 • Each participant was enrolled and followed by the study coordinator for a maximum period of 3 weeks (from enrollment and baseline measures to final measure collection). Because virtual reality has never been shown to have adverse events that last longer than the duration of the virtual reality device use, this time frame was most appropriate for adverse event data collection. Adverse events were first collected by the study coordinator during usual study processes and participant follow up and were each reviewed by the PI.

Other adverse events

Other adverse events
Measure	Virtual Reality (VR) Dosing Arm n=33 participants at risk All participants will proceed in this single arm, in which each participant will complete baseline measures, then receive 1 week of VR daily for 10 minutes per session, then 1 week of VR twice a day for 10 minutes per session, then 1 week of VR use as desired by the participant. Virtual reality experience for 10 minutes: Each 10-minute VR session will be self-administered (by each participant) using the Facebook (Facebook Inc., Menlo Park, CA) Meta Quest 2 VR and Touch controllers. This equipment was selected because it is portable, has built in audio, and has clear graphics at a lower price than VR setups that require a computer to generate graphics. The headset has an optional eyeglass spacer to allow participants to wear corrective eyeglasses during the VR session if appropriate. The hand controllers facilitate immersive, interactive VR experiences. The VR software, Nature Treks VR application (https://naturetreksvr.com) that features ten non-violent, nature-based experiences in peaceful environments (e.g. forest, river, beach, etc.) that can be played in a seated or fixed position.
General disorders Headache	3.0% 1/33 • Number of events 1 • Each participant was enrolled and followed by the study coordinator for a maximum period of 3 weeks (from enrollment and baseline measures to final measure collection). Because virtual reality has never been shown to have adverse events that last longer than the duration of the virtual reality device use, this time frame was most appropriate for adverse event data collection. Adverse events were first collected by the study coordinator during usual study processes and participant follow up and were each reviewed by the PI.
Nervous system disorders Dizziness	3.0% 1/33 • Number of events 1 • Each participant was enrolled and followed by the study coordinator for a maximum period of 3 weeks (from enrollment and baseline measures to final measure collection). Because virtual reality has never been shown to have adverse events that last longer than the duration of the virtual reality device use, this time frame was most appropriate for adverse event data collection. Adverse events were first collected by the study coordinator during usual study processes and participant follow up and were each reviewed by the PI.

Additional Information

Dr. Hunter Groninger

MedStar Health Research Institute

Phone: 202-877-7445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place