Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain
Keywords
Abstract
Description
This randomized controlled clinical trial was conducted between March and May of 2019. Participants were recruited through online advertisements on Facebook and The Mighty, a digital health community. Screening included a 2-item measure to assess for anhedonia and depressive symptoms experienced over the past two weeks. Potential participants were excluded from the study if they endorsed experiencing either depression or anhedonia nearly every day, and the other more than half the days. Eligible study participants were English-fluent adults 18-65 years of age, with either self-reported chronic low back pain without radicular symptoms and/or fibromyalgia pain of > 6 months duration,[29] and with average pain intensity > 4 (using the 11-point Numerical Rating Scale; 0=no pain, 10=worst pain imaginable) over the past month at screening. Exclusionary criteria included cognitive impairment, medical condition predisposing one to nausea or dizziness, hypersensitivity to flashing light or motion, absence of stereoscopic vision, severe hearing impairment, facial/head injury that would cause discomfort with VR use, cancer-related pain, severe depression, active suicidality, and previous use of Pain Care VR.
After informed consent was obtained study participants were randomized one-to-one using a REDCAP Cloud random number generator and allocated to treatment group. All study procedures were completed remotely and no in-person visits were required. Study participants were not blinded to treatment group assignment due to the obvious nature of the mode of delivery of their assigned treatment. Participant compensation was prorated based on the number of surveys completed; participants received up to $30 in the form of an Amazon.com e-gift card following completion of the final study survey. The study was approved by the Western Institutional Review Board (Puyallup, WA).
Data collection consisted of electronically collected patient-reported measures and objective use data collected from the VR devices and audio access logs.
In accordance with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations, multiple methods evaluated the importance of change in outcome measures across four recommended domains: pain intensity, health-related quality of life as defined by physical functioning, and ratings of overall Improvement.
Both treatment groups received the same didactic content delivered in distinct formats (VR vs. Audio). Treatment content consisted of a variety of sessions to support participants in learning cognitive and behavioral self-management skills based on evidence-based CBT principles and skills, biofeedback and mindfulness strategies used in pain management.
The 21-day program consisted of 4-8 treatment sessions from each content category with the duration of session length ranging from 1-15 minutes. Each treatment session was indexed as complete if participants initiated the experience. Participants were allowed to replay completed sessions.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 03/30/2020 |
| Estimated Enrollment Submitted: | 04/12/2020 |
| First Posted: | 04/13/2020 |
| Last Update Submitted: | 04/12/2020 |
| Last Update Posted: | 04/13/2020 |
| Actual Study Start Date: | 02/28/2019 |
| Estimated Primary Completion Date: | 05/29/2019 |
| Estimated Study Completion Date: | 05/29/2019 |
Condition or disease
Intervention/treatment
Device: VR Group
Other: Audio Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: VR Group VR group participants were mailed an Oculus Go Virtual Reality headset preloaded with VR software developed by AppliedVR. Treatment content consisted of a variety of 21 sessions to support participants in learning cognitive and behavioral self-management skills based on evidence-based CBT principles and skills, biofeedback and mindfulness strategies used in pain management. The program was designed to improve self-regulation of cognitive, emotion, and physiological response to stress and pain. | Device: VR Group Didactic content delivered in virtual reality to support participants in learning cognitive and behavioral self-management skills based on cognitive-based therapy, biofeedback, and mindfulness strategies for pain management. |
| Active Comparator: Audio Group The audio program consisted of the majority of the same narrative content contained in the VR program. Owing to VR having a visual and auditory media form, about one-third of the Audio program included didactic and experiential content that was not identifical but was closely matched to the VR content (sans references to visual imagery that would be confusing in the absence of visual content). Participants accessed 21 audio recordings on SoundCloud and asked to complete one session each day. | Other: Audio Group The audio program consisted of the majority of the same narrative content contained in the VR program. Owing to VR having a visual and auditory media form, about one-third of the VR program could not be included in the audio. Participants accessed 21 audio recordings on SoundCloud and asked to complete one session each day. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - English-fluent - adults 18-65 years old - have either self-reported chronic low back pain without radicular symptoms and/or fibromyalgia pain of > 6 months duration - average pain intensity > 4 (using the 11-point Numerical Rating Scale; 0=no pain, 10=worst pain imaginable) over the past month at screening. Exclusion Criteria: - Cognitive impairment - Current or prior diagnosis of epilepsy, dementia, migraines or other neurological disease that may prevent the use of VR - Hypersensitivity to flashing light or motion - No stereoscopic vision or severe hearing impairment - Injury to eyes, face or neck that prevents comfortable use of VR - Pain related to cancer - Active suicidal ideation or severe depression - Previous use of Pain Care VR for pain |
Outcome
Primary Outcome Measures
1. VR use [Day 1 through Day 21]
2. VR satisfaction [Day 22]
3. VR Nausea and motion sickness [Day 22]
Secondary Outcome Measures
1. Average Pain Intensity [Baseline and Day 21]
2. Pain Interference [Baseline and Day 21]
3. Pain-related Activity Interference [Baseline and Day 21]
4. Pain-related Mood Interference [Baseline and Day 21]
5. Pain-related Sleep Interference [Baseline and Day 21]
6. Pain-related Stress Interference [Baseline and Day 21]
7. Pain Catastrophizing [Baseline and Day 22]
8. Pain Self-Efficacy [Baseline and Day 22]
