Trial Outcomes & Findings for Virtual Reality for Pain Management Study (NCT NCT02997085)

Last Updated: 2021-06-23

Results Overview

The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment. It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad. Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine. Pain is current

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

Immediately following intervention

Results posted on

2021-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Live-Action 360° Video Virtual Reality Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
Overall Study STARTED	34	35	34
Overall Study COMPLETED	34	35	34
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Virtual Reality for Pain Management Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Live-Action 360° Video Virtual Reality n=34 Participants Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=35 Participants CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist n=34 Participants Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	96 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Age, Continuous	41.03 years STANDARD_DEVIATION 14.14 • n=5 Participants	43.83 years STANDARD_DEVIATION 13.51 • n=7 Participants	44.62 years STANDARD_DEVIATION 16.17 • n=5 Participants	43.17 years STANDARD_DEVIATION 14.58 • n=4 Participants
Sex/Gender, Customized Female	18 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	41 Participants n=4 Participants
Sex/Gender, Customized Male	16 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	61 Participants n=4 Participants
Sex/Gender, Customized Prefer Not to Report	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	83 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	29 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	34 participants n=5 Participants	35 participants n=7 Participants	34 participants n=5 Participants	103 participants n=4 Participants
Pain Questionnaire	5.97 units on a scale STANDARD_DEVIATION 1.88 • n=5 Participants	5.22 units on a scale STANDARD_DEVIATION 2.02 • n=7 Participants	6.29 units on a scale STANDARD_DEVIATION 2.37 • n=5 Participants	5.83 units on a scale STANDARD_DEVIATION 2.27 • n=4 Participants
Present Mood Questionnaire Depression	2.62 units on a scale STANDARD_DEVIATION 3 • n=5 Participants	2.17 units on a scale STANDARD_DEVIATION 2.71 • n=7 Participants	2.15 units on a scale STANDARD_DEVIATION 2.35 • n=5 Participants	2.33 units on a scale STANDARD_DEVIATION 2.68 • n=4 Participants
Present Mood Questionnaire Anxiety	4 units on a scale STANDARD_DEVIATION 3.47 • n=5 Participants	2.86 units on a scale STANDARD_DEVIATION 3.05 • n=7 Participants	3.18 units on a scale STANDARD_DEVIATION 3.33 • n=5 Participants	3.37 units on a scale STANDARD_DEVIATION 3.29 • n=4 Participants
Present Mood Questionnaire Happy	4.12 units on a scale STANDARD_DEVIATION 3.22 • n=5 Participants	4.71 units on a scale STANDARD_DEVIATION 3.27 • n=7 Participants	5.62 units on a scale STANDARD_DEVIATION 3.58 • n=5 Participants	4.80 units on a scale STANDARD_DEVIATION 3.40 • n=4 Participants
Present Mood Questionnaire Tranquil	5.44 units on a scale STANDARD_DEVIATION 3.25 • n=5 Participants	6.06 units on a scale STANDARD_DEVIATION 2.78 • n=7 Participants	6.21 units on a scale STANDARD_DEVIATION 2.71 • n=5 Participants	5.86 units on a scale STANDARD_DEVIATION 2.89 • n=4 Participants

PRIMARY outcome

Timeframe: Immediately following intervention

Outcome measures

Outcome measures
Measure	Live-Action 360° Video Virtual Reality n=34 Participants Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=35 Participants CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist n=34 Participants Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
Post-Treatment Pain Questionnaire	3.03 score on a scale Standard Deviation 2.3	2.77 score on a scale Standard Deviation 2.13	6.37 score on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.

Outcome measures

Outcome measures
Measure	Live-Action 360° Video Virtual Reality n=34 Participants Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=35 Participants CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist n=34 Participants Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
Follow-Up Pain Questionnaire	4.2 units on a scale Standard Deviation 2.32	4.14 units on a scale Standard Deviation 2.72	3.7 units on a scale Standard Deviation 3.04

SECONDARY outcome

Timeframe: Immediately following intervention

Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence. Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity. Higher for these two subscales indicate a better outcome. Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects. Higher scores for this subscale indicate a worse outcome. Questions on the scale are summed.

Outcome measures

Outcome measures
Measure	Live-Action 360° Video Virtual Reality n=34 Participants Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=35 Participants CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
Presence Inventory Ecological Validity	35.06 units on a scale Standard Deviation 7.69	25.62 units on a scale Standard Deviation 12.09	—
Presence Inventory Spatial Presence	25.79 units on a scale Standard Deviation 6.99	22.18 units on a scale Standard Deviation 8.97	—
Presence Inventory Negative Effects	1.09 units on a scale Standard Deviation 2.23	2 units on a scale Standard Deviation 5.68	—

SECONDARY outcome

Timeframe: Immediately after intervention

Self-report measure that assesses participant engagement with the virtual world. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions with a total score of 120. Higher scores indicate a better outcome and increased participant engagement.

Outcome measures

Outcome measures
Measure	Live-Action 360° Video Virtual Reality n=34 Participants Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=35 Participants CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
Absorption Survey	104.32 units on a scale Standard Deviation 16.52	96.2 units on a scale Standard Deviation 18.34	—

SECONDARY outcome

Timeframe: Every 10 minutes for 40 minutes following intervention

The Present Mood Questionnaire was used to assess the participant's current mood. The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil. It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden. Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.

Outcome measures

Outcome measures
Measure	Live-Action 360° Video Virtual Reality n=34 Participants Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=35 Participants CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist n=34 Participants Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
Present Mood Questionnaire Depression	.7 units on a scale Standard Deviation 1.45	.85 units on a scale Standard Deviation 1.88	2.25 units on a scale Standard Deviation 3.13
Present Mood Questionnaire Anxiety	1.24 units on a scale Standard Deviation 3.18	1.21 units on a scale Standard Deviation 2.27	2.25 units on a scale Standard Deviation 2.76
Present Mood Questionnaire Happy	6.52 units on a scale Standard Deviation 2.54	6.24 units on a scale Standard Deviation 3.38	5.34 units on a scale Standard Deviation 3.39
Present Mood Questionnaire Tranquil	7.7 units on a scale Standard Deviation 2.3	7.62 units on a scale Standard Deviation 2.71	6.56 units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: Immediately after intervention

Self-report measure that assesses the participant's attitude toward the VR experience. Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree. There are 12 questions for a total score of 120. Higher scores mean a more positive attitude towards the experience and is a better outcome.

Outcome measures

Outcome measures
Measure	Live-Action 360° Video Virtual Reality n=34 Participants Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=35 Participants CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.	Waitlist Participants randomized to the waitlist group will complete all study procedures except the VR exposure. After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
Attitudes Toward the Experience Survey	74.35 units on a scale Standard Deviation 10.93	67.51 units on a scale Standard Deviation 16.49	—

Adverse Events

Live-Action 360° Video Virtual Reality

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

CGI 360° Video Virtual Reality

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Live-Action 360° Video Virtual Reality n=66 participants at risk Live-Action 360° Video Virtual Reality: 360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.	CGI 360° Video Virtual Reality n=37 participants at risk CGI 360° Video Virtual Reality: Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
Eye disorders Eyestrain	9.1% 6/66 • Number of events 6 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.	13.5% 5/37 • Number of events 5 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.
Nervous system disorders Dizzy	6.1% 4/66 • Number of events 4 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.	10.8% 4/37 • Number of events 4 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.
Gastrointestinal disorders Nausea	4.5% 3/66 • Number of events 3 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.	5.4% 2/37 • Number of events 2 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.
Nervous system disorders Headache	3.0% 2/66 • Number of events 2 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.	5.4% 2/37 • Number of events 2 • One year Waitlist group was enrolled in other groups after the wait. Their numbers are included in the other group's counts. Participants in waitilist chose their own groups so numbers are not even.

Additional Information

Dr. Mark Powers

Baylor Scott & White Research Institute

Phone: 2148652409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place