Postoperative VR for Recovery After Bariatric Surgery

Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Complications; Postoperative Pain; Bariatric Surgery Candidate
• Intervention / Treatment: Other: Virtual Reality Immersive Relaxation

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Enhanced recovery after surgery protocol; Subjects in the control group will only undergo standard enhanced recovery after surgery care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU Opioid Requirements	The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents.	Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.
Length of PACU stay	The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes.	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	Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).	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	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 24 hours after post anesthesia unit discharge.
Hospital length of stay	The length of the patients stay following surgery.	Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Opioid requirements	Opioid requirements throughout the hospital stay.	Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Opioid-related adverse effects	Opioid-related adverse effects such as nausea or ileus.	Measured throughout the patients stay at the hospital, on average 1 to 3 days.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Israel-United States Binational Industrial Research and Development Foundation; XRHealth
• Investigators: Principal Investigator: Brian P O'Gara, MD,MP, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): June 1, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; ERAS
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2020P001149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No