Status:
ACTIVE_NOT_RECRUITING
Postoperative VR for Recovery After Bariatric Surgery
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Conditions:
Bariatric Surgery Candidate
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could i...
Detailed Description
The investigators propose conducting a randomized, controlled, single-center clinical trial of patients recovering from laparoscopic bariatric surgery. The objective is to investigate whether the use ...
Eligibility Criteria
Inclusion
- \- Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia.
Exclusion
- Age\<18
- 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- \- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04754165
Start Date
March 21 2022
End Date
June 30 2026
Last Update
July 14 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215