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

• Conditions: Rheumatoid Arthritis; Spondyloarthropathy; Vasculitis; Systemic Lupus Erythematosus
• Interventions: Device: VR-Biofeedback

• Registration Number: NCT03459274
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-03-16
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VR-Biofeedback Feedback Sharers	VR-Biofeedback	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.

Primary Outcome Measures

Name	Time	Method
Self-reported benefit of virtual reality-biofeedback experience	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 Outcome Measures

Name	Time	Method
Self-reported interest to try the virtual reality-biofeedback experience	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.

Trial Locations

Locations (1)

Attune Health; 🇺🇸 Beverly Hills, California, United States