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

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ClinicalTrials.gov Identifier: NCT03459274
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : May 31, 2018
Sponsor:
Collaborators:
AppliedVR, Inc.
Attune Health Research, Inc.
Information provided by (Responsible Party):
Swamy Venuturupalli, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Systemic Lupus Erythematosus Spondyloarthropathy Vasculitis Device: VR-Biofeedback

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology: An Observational Cohort Study
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


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:
  • Applied Virtual Reality
  • Virtual Reality
  • Biofeedback




Primary Outcome Measures :
  1. Self-reported benefit of virtual reality-biofeedback experience [ Time Frame: Within 10 minutes immediately after virtual reality experience completion ]
    In interview, subjects are asked to describe their perception of the level of benefit of the Virtual Reality-Biofeedback experience


Secondary Outcome Measures :
  1. Self-reported interest to try the virtual reality-biofeedback experience [ Time Frame: Within 10 minutes immediately before virtual reality experience start ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459274


Contacts
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Contact: Kunal Gogna, MD 310 652 0010 ext 123 kunal@attunehealth.com

Locations
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United States, California
Attune Health Recruiting
Beverly Hills, California, United States, 90024
Contact: Kunal Gogna, MD    310-652-0010 ext 123    kunal@attunehealth.com   
Principal Investigator: Swamy R Venuturupalli, MD, FACR         
Sponsors and Collaborators
Cedars-Sinai Medical Center
AppliedVR, Inc.
Attune Health Research, Inc.
Investigators
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Principal Investigator: Swamy R Venuturupalli, MD, FACR Cedars-Sinai Medical Center

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Responsible Party: Swamy Venuturupalli, MD, FACR, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03459274     History of Changes
Other Study ID Numbers: Pro00049211
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Vasculitis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Spondylarthropathies
Spondylarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Spondylitis
Spinal Diseases
Bone Diseases