CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
PainCare VR +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04345575
NCT04345575N/ACompleted

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

AppliedVR Inc.·interventional·Posted Apr 14, 2020·Updated Apr 14, 2020

In Brief

A clinical study evaluating PainCare VR and Audio content for Chronic Pain. Completed, enrolled 97 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 14, 2020
Enrollment StartMar 1, 2019
Primary CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.2 years ago

Interventions

PainCare VRdevice

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 contentother

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.