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

NCT03459274 | Unknown FDA Device

• 1 other identifier: Pro00049211
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Systemic Lupus Erythematosus; Spondyloarthropathy; Vasculitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-reported interest to try the virtual reality-biofeedback experience

  Within 10 minutes immediately before virtual reality experience start

Study Arms (1)

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

Interventions

VR-Biofeedback DEVICE

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.

Also known as: Applied Virtual Reality, Virtual Reality, Biofeedback

VR-Biofeedback Feedback Sharers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• AppliedVR Inc.: collaborator
• Attune Health Research, Inc.: collaborator

Study Sites (1)

Attune Health

Beverly Hills, California, 90024, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Spondylarthropathies; Vasculitis

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Swamy R Venuturupalli, MD, FACR

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kunal Gogna, MD

CONTACT

310 652 0010; kunal@attunehealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 8, 2018
• Study Start: March 16, 2018
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

US (1)