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Postoperative VR for Recovery After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT04754165
Recruitment Status : Not yet recruiting
First Posted : February 15, 2021
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Information provided by (Responsible Party):
Brian O'Gara, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Postoperative Pain Postoperative Complications Other: Virtual Reality Immersive Relaxation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 5 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 (Outcomes Assessor)
Masking Description: Assessors of the QOR15 recovery scale will be blinded to group assignment.
Primary Purpose: Treatment
Official Title: Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Quality of Recovery Questionnaires (QoR-15) [ Time Frame: Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery. ]
    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 :
  1. PACU Opioid Requirements [ Time Frame: Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery. ]
    The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents.

  2. Length of PACU stay [ 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. ]
    The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes.

  3. PACU pain scores using numeric rating scale [ 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. ]
    Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).

  4. Postoperative Quality of Recovery Questionnaires (QoR-15) score [ Time Frame: Measured at 24 hours after post anesthesia unit discharge. ]
    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.

  5. Hospital length of stay [ Time Frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days. ]
    The length of the patients stay following surgery.

  6. Opioid requirements [ Time Frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days. ]
    Opioid requirements throughout the hospital stay.

  7. Opioid-related adverse effects [ Time Frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days. ]
    Opioid-related adverse effects such as nausea or ileus.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754165


Contacts
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Contact: Brian P O'Gara, MD,MPH 617-754-3189 bpogara@bidmc.harvard.edu
Contact: Evynne Gartner, BA egartner@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: Brian P. O'Gara, MD, MPH    617-754-3189    bpogara@bidmc.harvard.edu   
Principal Investigator: Brian O'Gara, MD, MPH         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Investigators
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Principal Investigator: Brian P O'Gara, MD,MP Beth Israel Deaconess Medical Center
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Responsible Party: Brian O'Gara, Assistant Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04754165    
Other Study ID Numbers: 2020P001149
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian O'Gara, Beth Israel Deaconess Medical Center:
Virtual Reality
ERAS
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes