Recruiting

Virtual Reality

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03459274

Conditions

Rheumatoid Arthritis

Systemic Lupus Erythematosus

Spondyloarthropathy

Vasculitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VR-Biofeedback

Study Details

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

Study ID

NCT03459274

Start date

Mar 16, 2018

Status verified date

May, 2018

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Self-reported benefit of virtual reality-biofeedback experience [ Time Frame: Within 10 minutes immediately after virtual reality experience completion ]

Central Contacts and Locations

Central contacts

Locations

Attune Health

Recruiting

Beverly Hills, California, United States, 90024

Contacts

Principal Investigator:

Swamy R Venuturupalli, MD, FACR

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

May 31, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2018-05-31.