Trial Outcomes & Findings for VR Solace for Pain and Anxiety Using Survey and Biodata (NCT NCT05468086)

NCT ID: NCT05468086

Last Updated: 2024-11-04

Results Overview

Pain level pre- versus post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: Just prior to session to 15-minutes post session
• Results posted on: 2024-11-04

Participant Flow

The recruitment will be limited to one site, an inpatient hospital setting at Cedars-Sinai Medical Center (CSMC)

Participant milestones

Measure	Solace VR This arm will include software that provides immersive distraction based content for pain reduction. VR Solace: Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.
Overall Study STARTED	35
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Solace VR This arm will include software that provides immersive distraction based content for pain reduction. VR Solace: Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.
Overall Study Withdrawal by Subject	3
Overall Study Subject was found ineligible after consent	1

Baseline Characteristics

VR Solace for Pain and Anxiety Using Survey and Biodata

Baseline characteristics by cohort

Measure	Solace VR n=31 Participants This arm will include software that provides immersive distraction based content for pain reduction. VR Solace: Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.4 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 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	10 Participants n=5 Participants
Race (NIH/OMB) White	16 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

PRIMARY outcome

Timeframe: Just prior to session to 15-minutes post session

Population: Age 18 years or older who suffer from chronic pain, have ongoing pain of equal or greater than 3 on an 11-point numerical rating scale, and were capable of giving informed consent.

Pain level pre- versus post-VR Solace as measured by Patient-Reported 11-point numeric rating scale (Continuous, 0-10, higher the worse).

Outcome measures

Measure	Pre-Solace VR n=31 Participants This arm is participants pre-VR intervention VR Solace: Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.	Post-VR Solace n=31 Participants This arm is participants post-VR intervention
Patient-reported Pain Level Pre Versus Post-VR Session	6.6 score on a scale Standard Deviation 2.0	5.1 score on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: Just prior to VR session and 15 minutes after the VR session

Population: Age 18 years or older who suffer from chronic pain, have ongoing pain of equal or greater than 3 on an 11-point numerical rating scale, and were capable of giving informed consent.

Anxiety level pre versus post-VR Solace as measured by Patient-Reported 6-question version of State-Trait Anxiety Inventory (4-point scale, 1 to 4, for each question, e.g. from "Almost Never" to "Almost Always". The scores are added up to produce a total score of anxiety. Higher scores indicate greater anxiety). Scores range from 20 to 80, with higher scores reflecting increased anxiety.

Outcome measures

Measure	Pre-Solace VR n=31 Participants This arm is participants pre-VR intervention VR Solace: Participants will use the VR audio and visual head-mounted device. The device is a standalone VR headset. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.	Post-VR Solace n=31 Participants This arm is participants post-VR intervention
Patient-reported Anxiety Level Pre Versus Post-VR Session	46.7 score on a scale Standard Deviation 12.2	35.6 score on a scale Standard Deviation 11.2

Adverse Events

Solace VR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Omer Liran, MD, MSHS

Cedars-Sinai Medical Center

Phone: 31042333754

Email: omer.liran@cshs.org

Results disclosure agreements

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