Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain

Trial ID or NCT#

NCT04345575

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: A Randomized Controlled Pilot Study

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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

Investigator(s)

Beth Darnall
Beth Darnall
Pain management specialist, Pain psychologist
Professor of Anesthesiology, Perioperative and Pain Medicine (Adult Pain) and, by courtesy, of Psychiatry and Behavioral Sciences (General Psychiatry & Psychology (Adult))