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Postoperative VR for Recovery After Bariatric Surgery

Primary Purpose

Bariatric Surgery Candidate, Postoperative Pain, Postoperative Complications

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Immersive Relaxation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring Virtual Reality, ERAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immersive Virtual Reality plus the enhanced recovery after surgery protocol

Enhanced recovery after surgery protocol

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PACU Opioid Requirements
The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents.
Length of PACU stay
The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes.
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).
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.
Hospital length of stay
The length of the patients stay following surgery.
Opioid requirements
Opioid requirements throughout the hospital stay.
Opioid-related adverse effects
Opioid-related adverse effects such as nausea or ileus.

Full Information

First Posted
January 29, 2021
Last Updated
June 9, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Israel-United States Binational Industrial Research and Development Foundation, XRHealth
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1. Study Identification

Unique Protocol Identification Number
NCT04754165
Brief Title
Postoperative VR for Recovery After Bariatric Surgery
Official Title
Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Israel-United States Binational Industrial Research and Development Foundation, XRHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Postoperative Pain, Postoperative Complications
Keywords
Virtual Reality, ERAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Assessors of the QOR15 recovery scale will be blinded to group assignment.
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immersive Virtual Reality plus the enhanced recovery after surgery protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced recovery after surgery protocol
Arm Type
No Intervention
Arm Description
Subjects in the control group will only undergo standard enhanced recovery after surgery care.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Immersive Relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Recovery Questionnaires (QoR-15)
Description
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.
Time Frame
Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery.
Secondary Outcome Measure Information:
Title
PACU Opioid Requirements
Description
The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents.
Time Frame
Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.
Title
Length of PACU stay
Description
The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes.
Time Frame
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.
Title
PACU pain scores using numeric rating scale
Description
Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Time Frame
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.
Title
Postoperative Quality of Recovery Questionnaires (QoR-15) score
Description
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.
Time Frame
Measured at 24 hours after post anesthesia unit discharge.
Title
Hospital length of stay
Description
The length of the patients stay following surgery.
Time Frame
Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Title
Opioid requirements
Description
Opioid requirements throughout the hospital stay.
Time Frame
Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Title
Opioid-related adverse effects
Description
Opioid-related adverse effects such as nausea or ileus.
Time Frame
Measured throughout the patients stay at the hospital, on average 1 to 3 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian P O'Gara, MD,MPH
Phone
617-754-3189
Email
bpogara@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Evynne Gartner, BA
Email
egartner@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian P O'Gara, MD,MP
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian P. O'Gara, MD, MPH
Phone
617-754-3189
Email
bpogara@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Brian O'Gara, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative VR for Recovery After Bariatric Surgery

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