Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): PainCare VR; Audio content
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group design where enrolled participants are randomly assigned to one of two treatment groups: Virtual reality behavioral medicine for chronic pain or Audio behavioral medicine for chronic pain
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual reality; chronic pain; behavioral health; behavioral medicine