Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology
NCT ID: NCT03459274
Last Updated: 2018-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2018-03-16
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 have a history of vertigo and/or dizziness
* Patients with a history of seizure disorder
18 Years
ALL
No
Sponsors
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AppliedVR Inc.
INDUSTRY
Attune Health Research, Inc.
INDUSTRY
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Swamy Venuturupalli
MD, FACR
Principal Investigators
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Swamy R Venuturupalli, MD, FACR
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Attune Health
Beverly Hills, California, United States
Countries
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Central Contacts
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Facility Contacts
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Kunal Gogna, MD
Role: primary
Other Identifiers
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Pro00049211
Identifier Type: -
Identifier Source: org_study_id