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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ACTIVE_NOT_RECRUITING
NA
106 participants
INTERVENTIONAL
2022-03-21
2026-06-30
Brief Summary
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Detailed Description
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The investigators hypothesize that immersive VR will improve subjective quality of recovery scores at time of Post Anesthesia Care Unit (PACU) discharge as compared to standard ERAS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The first 6 patients enrolled will be assigned to the VR group for the purposes of a pilot phase with the objective of identifying and refining any issues with the intervention. Data for these patients will not be included in the statistical analysis.
TREATMENT
SINGLE
Study Groups
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Immersive Virtual Reality plus the enhanced recovery after surgery protocol
Patients in the immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones in the post anesthesia care unit (PACU) after surgery. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface.
Patients in the VR group will also be treated according to the existing enhanced recovery after surgery protocol.
Virtual Reality Immersive Relaxation
The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
Enhanced recovery after surgery protocol
Subjects in the control group will only undergo standard enhanced recovery after surgery care.
No interventions assigned to this group
Interventions
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Virtual Reality Immersive Relaxation
The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Open wounds or active infection of the face or eye area
* History of seizures or other symptom linked to an epileptic condition
* Patients with hearing aids who are unable to tolerate wearing headphones with their hearing aids
* Patients with a pacemaker or other implanted medical device
* Droplet or airborne precautions (as determined by BIDMC infection control policy)
* Non English Speaking or non Spanish Speaking
* Chronic opioid dependence (existing oral opioid prescription for \>3 months, methadone, suboxone)
Drop Out Criteria: (after enrollment and randomization, before intervention)
\- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols
18 Years
ALL
No
Sponsors
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Israel-United States Binational Industrial Research and Development Foundation
UNKNOWN
XRHealth
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Brian O'Gara
Assistant Professor of Anaesthesia
Principal Investigators
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Brian P O'Gara, MD,MP
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Espinosa-Leon JP, Mathura R, Chen G, Joseph M, Sadhwani T, Beydoun N, Hernandez ER, Riley T, Goodspeed V, O'Gara BP. Postoperative virtual reality for recovery after bariatric surgery: study protocol for a randomised clinical trial. BJA Open. 2024 Feb 5;9:100258. doi: 10.1016/j.bjao.2024.100258. eCollection 2024 Mar.
Other Identifiers
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2020P001149
Identifier Type: -
Identifier Source: org_study_id
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