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Trial record 4 of 18 for:    AppliedVR

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

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ClinicalTrials.gov Identifier: NCT04345575
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
AppliedVR Inc.

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Device: PainCare VR Other: Audio content Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
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
Official Title: Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: A Randomized Controlled Pilot Study
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: VR Group
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
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.

Active Comparator: Audio Group
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
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.




Primary Outcome Measures :
  1. VR use [ Time Frame: Day 1 through Day 21 ]
    VR use will be calculated as the total number of sessions launched for the VR group.

  2. VR satisfaction [ Time Frame: Day 22 ]
    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).

  3. VR Nausea and motion sickness [ Time Frame: Day 22 ]
    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.


Secondary Outcome Measures :
  1. Average Pain Intensity [ Time Frame: Baseline and Day 21 ]
    Compare between group (VR vs Audio) pre-post treatment pain intensity (0-10 numeric rating scale) end of treatment on Day 21.

  2. Pain Interference [ Time Frame: Baseline and Day 21 ]
    Department of Defense/Veterans Administration (DoD/VA) Scale assesses pain interference over the previous 24 hours at two time points: Baseline and end of treatment on Day 21 (0=does not interfere; 10=completely interferes). Between group (VR vs Audio) pre-post treatment for pain interference will be compared.

  3. Pain-related Activity Interference [ Time Frame: Baseline and Day 21 ]
    Department of Defense/Veterans Administration (DoD/VA) Scale assesses activity interference over the previous 24 hours at two time points: Baseline and end of treatment on Day 21 (0=does not interfere; 10=completely interferes). Between group (VR vs Audio) pre-post treatment for activity interference will be compared.

  4. Pain-related Mood Interference [ Time Frame: Baseline and Day 21 ]
    Department of Defense/Veterans Administration (DoD/VA) Scale assesses mood interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21(0=does not interfere; 10=completely interferes). The investigators will compare mood interference between group (VR vs Audio) pre-post treatment.

  5. Pain-related Sleep Interference [ Time Frame: Baseline and Day 21 ]
    Department of Defense/Veterans Administration (DoD/VA) Scale assesses sleep interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21 (0=does not interfere; 10=completely interferes). The investigators will compare sleep interference between group (VR vs Audio) pre-post treatment.

  6. Pain-related Stress Interference [ Time Frame: Baseline and Day 21 ]
    Department of Defense/Veterans Administration (DoD/VA) Scale assesses stress interference over the previous 24 hours at two time points: Baseline end of treatment on Day 21 (0=does not interfere; 10=completely interferes). The investigators will compare stress interference between group (VR vs Audio) pre-post treatment .

  7. Pain Catastrophizing [ Time Frame: Baseline and Day 22 ]
    Pain Catastrophizing Scale (PCS) assesses frequency of pain-related thoughts and feelings on a 0-4 scale (0=not at all; 4=all the time). The PCS is assessed at baseline and post-treatment at day 22. There is no specific time referent for this measure. The investigators compared PCS between group (VR vs Audio) pre-post treatment.

  8. Pain Self-Efficacy [ Time Frame: Baseline and Day 22 ]
    The 2-item PSEQ (PSEQ-2) is used to assess pain self-efficacy. Respondents rate their responses to the items using a 7-point scale ranging from 0 (Not at all confident) to 4 (Completely confident). The two item scores are summed to create a total score. The investigators will compare pain self-efficacy (PSEQ-2) between group (VR vs Audio) pre-post treatment .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345575


Locations
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United States, California
AppliedVR, Inc.
Los Angeles, California, United States, 90067
Sponsors and Collaborators
AppliedVR Inc.
Investigators
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Principal Investigator: Beth Darnall, PhD Stanford University
Additional Information:
Publications:
Darnall BD. Psychological Treatment for Patients with Chronic Pain. Washington, D.C.: American Psychological Association Press; 2018.
Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychological Assessment, 7(4), 524-532. https://doi.org/10.1037/1040-3590.7.4.524

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Responsible Party: AppliedVR Inc.
ClinicalTrials.gov Identifier: NCT04345575    
Other Study ID Numbers: 2019-03
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AppliedVR Inc.:
virtual reality
chronic pain
behavioral health
behavioral medicine
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations