Postoperative VR for Recovery After Bariatric Surgery

NCT04754165 | Active Not Recruiting DMC

• 1 other identifier: 2020P001149
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Postoperative Pain; Postoperative Complications

Keywords

Virtual Reality; ERAS

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery Questionnaires (QoR-15)

  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.

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

Secondary Outcomes (7)

• PACU Opioid Requirements

  Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.

• 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.

• 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.

• Postoperative Quality of Recovery Questionnaires (QoR-15) score

  Measured at 24 hours after post anesthesia unit discharge.

• Hospital length of stay

  Measured throughout the patients stay at the hospital, on average 1 to 3 days.

Study Arms (2)

Immersive Virtual Reality plus the enhanced recovery after surgery protocol

EXPERIMENTAL

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.

Other: Virtual Reality Immersive Relaxation

Enhanced recovery after surgery protocol

NO INTERVENTION

Subjects in the control group will only undergo standard enhanced recovery after surgery care.

Interventions

Virtual Reality Immersive Relaxation OTHER

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.

Immersive Virtual Reality plus the enhanced recovery after surgery protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Israel-United States Binational Industrial Research and Development Foundation: collaborator
• XRHealth: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 38333728 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Brian P O'Gara, MD,MP

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of the QOR15 recovery scale will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesia

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 15, 2021
• Study Start: March 21, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)