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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis, Systemic Lupus Erythematosus, Spondyloarthropathy, Vasculitis

Intervention / Treatment
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* Device: VR-Biofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VR-Biofeedback Feedback Sharers<br>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. | Device: VR-Biofeedback<br>* 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.<br>* Other names: Biofeedback;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported interest to try the virtual reality-biofeedback experience | 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. | Within 10 minutes immediately before virtual reality experience start |