CClinicalTrials.gg
Status unknownNCT03459274Updated May 31, 2018

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

An observational study in Rheumatoid Arthritis, Systemic Lupus Erythematosus and Spondyloarthropathy, sponsored by Cedars-Sinai Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Cedars-Sinai Medical Center · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Spondyloarthropathy
  • Vasculitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceVR-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.

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

05

What researchers measure

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

    Time frame: Within 10 minutes immediately after virtual reality experience completion

Secondary outcomes

  1. 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.

    Time frame: Within 10 minutes immediately before virtual reality experience start

06

Study locations

1 of 1 sites recruiting
  • Attune Health
    Beverly Hills, California 90024, United States
    • Kunal Gogna, MD · Contact · kunal@attunehealth.com · 310-652-0010
    • Swamy R Venuturupalli, MD, FACR · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03459274
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
AppliedVR Inc., Attune Health Research, Inc.
Responsible party
Swamy Venuturupalli (MD, FACR, Cedars-Sinai Medical Center) — Principal investigator
First posted
Mar 8, 2018
Start date
Mar 16, 2018
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
May 31, 2018

Study contacts

Kunal Gogna, MD
Contact
kunal@attunehealth.com
310 652 0010 ext. 123
Swamy R Venuturupalli, MD, FACR
principal investigator · Cedars-Sinai Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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