Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain
CompletedNot applicableNCT04345575
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic pain management is optimized with a multidisciplinary biopsychosocial treatment approach. However, patients have limited access to comprehensive care that includes behavioral medicine for chronic pain. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapeutic with analgesic efficacy for acute pain. No scientific literature was found for skills-based VR behavioral programs for chronic pain populations. 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.
Study details
- Official title
- Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: A Randomized Controlled Pilot Study
- Conditions
- Interventions
- Device: PainCare VR
- Other: Audio content
- Sponsor
- AppliedVR Inc.
- Start date
- 2019-03-01
- Primary completion
- 2019-05-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04345575