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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03459274
Enrollment
20
Registered
2018-03-08
Start date
2018-03-16
Completion date
2018-06-30
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Spondyloarthropathy, Systemic Lupus Erythematosus, Vasculitis

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.

Interventions

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.

Sponsors

AppliedVR Inc.
CollaboratorINDUSTRY
Attune Health Research, Inc.
CollaboratorINDUSTRY
Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported benefit of virtual reality-biofeedback experienceWithin 10 minutes immediately after virtual reality experience completionIn interview, subjects are asked to describe their perception of the level of benefit of the Virtual Reality-Biofeedback experience

Secondary

MeasureTime frameDescription
Self-reported interest to try the virtual reality-biofeedback experienceWithin 10 minutes immediately before virtual reality experience startPatients 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.

Countries

United States

Contacts

Primary ContactKunal Gogna, MD
kunal@attunehealth.com310 652 0010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026