Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology

Overview

The purpose is to study the use of virtual reality (VR) and biofeedback in rheumatology clinics to help manage chronic pain in patients with rheumatologic diseases. The objective is to know the usefulness of VR/biofeedback-based therapy in the clinic.

Full Title of Study: “Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology: An Observational Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2018

Interventions

  • Device: VR-Biofeedback
    • The intervention uses a smart phone with a virtual reality app; a headset that connects to the phone and has goggles that contribute to the 3 dimensional, interactive, and surrounding aspects of the experience; headphones through which subjects hear calming sounds and guiding voices from the experience; an attached microphone that allows subjects to monitor their breathing and interact with their environment through their breath; and a heart rate monitor whose realtime data on variability has an affect on the virtual environment. The virtual reality experience guides subjects through deep breathing exercises. Subjects will attempt to match a certain slow breathing rate, and pulse and breathing rate will cause non-stressful changes to the environment.

Arms, Groups and Cohorts

  • VR-Biofeedback Feedback Sharers
    • These participants would express either interest or a lack of interest in trying biofeedback/virtual reality therapy. They will be instructed on how to use the virtual reality equipment and program. Then, they will have the option to participate in the biofeedback/virtual reality experience, if they choose to do so, before sharing their feedback.

Clinical Trial Outcome Measures

Primary Measures

  • Self-reported benefit of virtual reality-biofeedback experience
    • Time Frame: Within 10 minutes immediately after virtual reality experience completion
    • In interview, subjects are asked to describe their perception of the level of benefit of the Virtual Reality-Biofeedback experience

Secondary Measures

  • Self-reported interest to try the virtual reality-biofeedback experience
    • Time Frame: Within 10 minutes immediately before virtual reality experience start
    • Patients who are consented and fit inclusion criteria are asked, in interview, if they would be interested in trying the virtual reality experience and providing a rationale for their choice.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients with Rheumatoid arthritis, Systemic Lupus Erythematosus, Seronegative Spondyloarthropathy, Myositis, Psoriatic Arthritis, vasculitis or other autoimmune conditions.
  • Patients must be on a stable regimen of medications.
  • Patients should have pain, measured at the time of entry using a Visual Analog scale, of >5/10 at least 4 days in the last 30 days

Exclusion Criteria

  • Patients who are deemed by the study team to be unable to use the VR headset and follow instructions for any reason.
  • Patients who have a history of vertigo and/or dizziness
  • Patients with a history of seizure disorder

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cedars-Sinai Medical Center
  • Collaborator
    • AppliedVR Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Swamy Venuturupalli, MD, FACR – Cedars-Sinai Medical Center
  • Overall Official(s)
    • Swamy R Venuturupalli, MD, FACR, Principal Investigator, Cedars-Sinai Medical Center
  • Overall Contact(s)
    • Kunal Gogna, MD, 310 652 0010, kunal@attunehealth.com

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