Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain
NCT ID: NCT04345575
Last Updated: 2020-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2019-03-01
2019-05-30
Brief Summary
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The primary goal of this study was to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based cognitive behavioral treatment for chronic pain. The secondary goal was to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary goal was to conduct a randomized controlled trial to compare the VR treatment to an audio-only treatment; this comparison isolated the immersive effects of the skills-based VR program, thereby informing potential mechanisms of effect.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
PainCare VR
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.
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.
Audio content
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.
Interventions
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PainCare VR
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.
Audio content
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
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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AppliedVR Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Beth Darnall, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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AppliedVR, Inc.
Los Angeles, California, United States
Countries
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References
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Other Identifiers
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2019-03
Identifier Type: -
Identifier Source: org_study_id
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