Postoperative VR for Recovery After Bariatric Surgery

Postoperative Pain Clinical Trial

Official title:

Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754165
• Other study ID #: 2020P001149
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Postoperative Complications
• Postoperative Pain

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.