NCT03459274

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Spondyloarthropathy
• Vasculitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-16
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2018-03-08
• Last updated: 2018-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study