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Clinical Trials/NCT04754165
NCT04754165
Active, not recruiting
Not Applicable

Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery

Beth Israel Deaconess Medical Center1 site in 1 country106 target enrollmentMarch 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
106
Locations
1
Primary Endpoint
Quality of Recovery Questionnaires (QoR-15)
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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 improve postoperative recovery from bariatric surgery.

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 of virtual reality (VR) during the immediate postoperative period could improve patient reported quality of recovery and potentially reduce opioid analgesic requirements as compared to an existing ERAS protocol. 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.

Registry
clinicaltrials.gov
Start Date
March 21, 2022
End Date
June 30, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian O'Gara

Assistant Professor of Anaesthesia

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia.

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

Outcomes

Primary Outcomes

Quality of Recovery Questionnaires (QoR-15)

Time Frame: Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery.

The primary outcome of this study will be patient reported quality of recovery at time of PACU discharge, as assessed by the QOR-15. The QOR-15 is a validated instrument to assess postoperative recovery from the patient's perspective, assessing overall well-being, nausea, pain, and anxiety and depression following surgery.

Secondary Outcomes

  • PACU Opioid Requirements(Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.)
  • Postoperative Quality of Recovery Questionnaires (QoR-15) score(Measured at 24 hours after post anesthesia unit discharge.)
  • Opioid-related adverse effects(Measured throughout the patients stay at the hospital, on average 1 to 3 days.)
  • Length of PACU stay(Duration of the patient's stay in the post anesthesia care unit, from time of admission to time of readiness for PACU discharge, on average 1 to 5 hours.)
  • Hospital length of stay(Measured throughout the patients stay at the hospital, on average 1 to 3 days.)
  • PACU pain scores using numeric rating scale(Administered every hour following admission to the post anesthesia care unit until discharge from the post anesthesia care unit, on average 1 to 5 hours.)
  • Opioid requirements(Measured throughout the patients stay at the hospital, on average 1 to 3 days.)

Study Sites (1)

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