Postoperative VR for Recovery After Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery

Conditions
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Postoperative Pain, Bariatric Surgery Candidate, Postoperative Complications

Intervention / Treatment
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* Other: Virtual Reality Immersive Relaxation


Participation Criteria
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Eligibility Criteria
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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 who plan to wear hearing aids during the procedure Patients with a pacemaker or other implanted medical device Droplet or airborne precautions (as determined by BIDMC infection control policy) Non English 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and randomization, before intervention) - Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immersive Virtual Reality plus the enhanced recovery after surgery protocol<br>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<br>* 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.<br>|
| No Intervention: Enhanced recovery after surgery protocol<br>Subjects in the control group will only undergo standard enhanced recovery after surgery care. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, ERAS