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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03459274
• Other study ID #: Pro00049211
• Status: Recruiting
• Start date: March 16, 2018
• Est. completion date: June 2018

Study information

• Verified date: May 2018
• Source: Cedars-Sinai Medical Center
• Contact: Kunal Gogna, MD
• Phone: 310 652 0010
• Email: kunal[@]attunehealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Lupus Erythematosus, Systemic
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylarthropathies
• Spondyloarthropathy
• Systemic Lupus Erythematosus
• Vasculitis

Intervention

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.

Locations

Country	Name	City	State
United States	Attune Health	Beverly Hills	California

Sponsors (3)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	AppliedVR, Inc., Attune Health Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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