Boston, Massachusetts 02215

  • Postoperative Complications

Purpose:

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 summary:

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.


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)


Study is Available At:


Original ID:

2020P001149


NCT ID:

NCT04754165


Secondary ID:


Study Acronym:


Brief Title:

Postoperative VR for Recovery After Bariatric Surgery


Official Title:

Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery


Overall Status:

Not yet recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Beth Israel Deaconess Medical Center


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Brian P O'Gara, MD,MP
Principal Investigator
Beth Israel Deaconess Medical Center
Primary Contact:Brian P O'Gara, MD,MPH
617-754-3189
bpogara@bidmc.harvard.edu
Backup Contact:Evynne Gartner, BA
egartner@bidmc.harvard.edu

Study Dates

Start Date:June 1, 2021
Completion Date:September 30, 2022
Completion Type:Anticipated
Primary Completion Date:June 30, 2022
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 28, 2021
First Received Date:January 29, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False
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 we
Outcome Type:Secondary Outcome
Measure:PACU Opioid Requirements
Time Frame:Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after
Safety Issues:False
Description:The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents.
Outcome Type:Secondary Outcome
Measure: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 r
Safety Issues:False
Description:The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes.
Outcome Type:Secondary Outcome
Measure:PACU pain scores using numeric rating scale
Time Frame:Administered every hour following admission to the post anesthesia care unit until discharge from th
Safety Issues:False
Description:Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Outcome Type:Secondary Outcome
Measure:Postoperative Quality of Recovery Questionnaires (QoR-15) score
Time Frame:Measured at 24 hours after post anesthesia unit discharge.
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Hospital length of stay
Time Frame:Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Safety Issues:False
Description:The length of the patients stay following surgery.
Outcome Type:Secondary Outcome
Measure:Opioid requirements
Time Frame:Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Safety Issues:False
Description:Opioid requirements throughout the hospital stay.
Outcome Type:Secondary Outcome
Measure:Opioid-related adverse effects
Time Frame:Measured up to 48 hours after surgery.
Safety Issues:False
Description:Opioid-related adverse effects such as nausea or ileus.

Study Interventions

Intervention Type:Other
Name:Virtual Reality Immersive Relaxation
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.
Arm Name:Immersive Virtual Reality plus the enhanced recove

Study Arms

Study Arm Type:No Intervention
Arm Name:Enhanced recovery after surgery protocol
Description:Subjects in the control group will only undergo standard enhanced recovery after surgery care.
Study Arm Type:Experimental
Arm Name:Immersive Virtual Reality plus the enhanced recovery after surgery protocol
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. 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. Pa

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Beth Israel Deaconess Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:Israel-United States Binational Industrial Research and Development Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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