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

NCT04345575 | Completed

• 1 other identifier: 2019-03
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

virtual reality; chronic pain; behavioral health; behavioral medicine

Outcome Measures

Primary Outcomes (3)

• VR use

  VR use will be calculated as the total number of sessions launched for the VR group.

  Day 1 through Day 21

• VR satisfaction

  Participant satisfaction ratings will be assessed using the question, "How satisfied or dissatisfied are you with the ability of this VR (Audio) program to relieve your symptoms" on a 5-point scale (1=Extremely Dissatisfied to 5=Extremely Satisfied). Satisfaction with treatment will be reported as percentages for the satisfaction categories 1-5 (on day 22).

  Day 22

• VR Nausea and motion sickness

  Nausea and motion sickness will be assessed on day 22 (post-treatment survey) using the question, "Did you experience any motion sickness or nausea while using VR?" on 4-point with 0=Never, 1=Sometimes, 2=Often, and 3=Always. The proportion of participants who did not experience any nausea/motion sickness will be reported.

  Day 22

Secondary Outcomes (8)

• Average Pain Intensity

  Baseline and Day 21

• Pain Interference

  Baseline and Day 21

• Pain-related Activity Interference

  Baseline and Day 21

• Pain-related Mood Interference

  Baseline and Day 21

• Pain-related Sleep Interference

  Baseline and Day 21

Study Arms (2)

VR Group

EXPERIMENTAL

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: PainCare VR

Audio Group

ACTIVE COMPARATOR

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 content

Interventions

PainCare VR DEVICE

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.

VR Group

Audio content OTHER

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.

Audio Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AppliedVR Inc.: lead

Study Sites (1)

AppliedVR, Inc.

Los Angeles, California, 90067, United States

Location

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MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beth Darnall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 14, 2020
• Study Start: March 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)