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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04754165
Other study ID # 2020P001149
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2022
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source Beth Israel Deaconess Medical Center
Contact Brian P O'Gara, MD,MPH
Phone 617-754-3189
Email bpogara@bidmc.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 106
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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and randomization, before intervention) - Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols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 Design


Intervention

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.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Israel-United States Binational Industrial Research and Development Foundation, XRHealth

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Opioid requirements Opioid requirements throughout the hospital stay. Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Secondary 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.
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