Clinical trial NCT04754165: Postoperative VR for Recovery After Bariatric Surgery
Official title: Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Postoperative Pain
Postoperative Complications
Keywords: Virtual Reality
ERAS
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Israel-United States Binational Industrial Research and Development Foundation
name: XRHealth
First posted: 2021-02-15
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Research participants will be randomized to one of two groups: immersive VR plus ERAS, or ERAS alone in a 1:1 allocation.

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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of Recovery Questionnaires (QoR-15)
timeFrame: Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery.
Secondary outcomes:
measure: PACU Opioid Requirements
timeFrame: Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.
measure: Length of PACU stay
timeFrame: 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.
measure: PACU pain scores using numeric rating scale
timeFrame: 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.
measure: Postoperative Quality of Recovery Questionnaires (QoR-15) score
timeFrame: Measured at 24 hours after post anesthesia unit discharge.
measure: Hospital length of stay
timeFrame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
measure: Opioid requirements
timeFrame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
measure: Opioid-related adverse effects
timeFrame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Brian P O'Gara, MD,MP
role: PRINCIPAL_INVESTIGATOR
References: