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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Vasculitis; Spondyloarthropathy
• Intervention / Treatment: Device: VR-Biofeedback

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Kunal Gogna, MD; Phone Number: 123 310 652 0010; Email: kunal@attunehealth.com

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90024
      • Recruiting
      • Attune Health
      • Contact: Kunal Gogna, MD; Phone Number: 123 310-652-0010; Email: kunal@attunehealth.com
      • Principal Investigator: Swamy R Venuturupalli, MD, FACR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Rheumatoid arthritis, SLE, 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: Virtual Reality; Biofeedback; Applied Virtual Reality

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Attune Health Research, Inc.; AppliedVR Inc.
• Investigators: Principal Investigator: Swamy R Venuturupalli, MD, FACR, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Lupus Erythematosus, Systemic; Vasculitis; Spondylitis; Spondylarthritis; Spondylarthropathies
• Other Study ID Numbers: Pro00049211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No