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Virtual Reality Immersive Relaxation for Postoperative Complications

N/A
Recruiting
Led By Brian P O'Gara, MD,MP
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia
Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured throughout the patients stay at the hospital, on average 1 to 3 days.
Awards & highlights

Study Summary

This trial will investigate whether adding virtual reality to an enhanced recovery protocol could improve postoperative recovery for patients who have had bariatric surgery.

Who is the study for?
This trial is for adults undergoing laparoscopic bariatric surgery under general anesthesia. It's not suitable for those with open facial wounds, infections near the eyes, airborne precautions, non-English speakers, chronic opioid users, individuals under 18, pacemaker users or anyone with a history of seizures.Check my eligibility
What is being tested?
The study tests if using immersive virtual reality (VR) right after bariatric surgery can help patients recover better as part of an enhanced recovery protocol. Participants will experience VR relaxation sessions post-surgery.See study design
What are the potential side effects?
While VR is generally safe, it may cause temporary discomfort like dizziness or nausea in some people. Those with a history of seizures should avoid it due to potential seizure risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having weight loss surgery at BIDMC under general anesthesia.
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If my surgery changes to an open procedure, I will be withdrawn from the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of Recovery Questionnaires (QoR-15)
Secondary outcome measures
Hospital length of stay
Length of PACU stay
Opioid requirements
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immersive Virtual Reality plus the enhanced recovery after surgery protocolExperimental Treatment1 Intervention
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.
Group II: Enhanced recovery after surgery protocolActive Control1 Intervention
Subjects in the control group will only undergo standard enhanced recovery after surgery care.

Find a Location

Who is running the clinical trial?

XRHealthUNKNOWN
1 Previous Clinical Trials
131 Total Patients Enrolled
Israel-United States Binational Industrial Research and Development FoundationUNKNOWN
1 Previous Clinical Trials
131 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,166 Total Patients Enrolled
2 Trials studying Postoperative Complications
160 Patients Enrolled for Postoperative Complications

Media Library

Virtual Reality Immersive Relaxation Clinical Trial Eligibility Overview. Trial Name: NCT04754165 — N/A
Postoperative Complications Research Study Groups: Immersive Virtual Reality plus the enhanced recovery after surgery protocol, Enhanced recovery after surgery protocol
Postoperative Complications Clinical Trial 2023: Virtual Reality Immersive Relaxation Highlights & Side Effects. Trial Name: NCT04754165 — N/A
Virtual Reality Immersive Relaxation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04754165 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for this clinical research at present?

"Affirmative. According to information available on clinicaltrials.gov, the trial is in recruitment mode. It was initially posted on March 21st 2022 and revised for the last time two months ago (October 19th). The research needs 105 volunteers from a single location."

Answered by AI

What is the quota for participants in this clinical investigation?

"Affirmative, the information on clinicaltrials.gov states that this trial is actively enrolling participants. It was initially announced on March 21st 2022 and had its last edit made on October 19th of the same year. One site needs to recruit a total of 105 individuals for the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Postoperative VR for Recovery After Bariatric Surgery
Brian O'Gara 2022. "Postoperative VR for Recovery After Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04754165.
~26 spots leftby Dec 2024
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