Virtual Reality in the Operating Room

Study Overview
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Brief Summary
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This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.

Official Title
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Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia

Conditions
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Anesthesia, Intravenous, Pain, Postoperative, Delayed Recovery From Anesthesia, Satisfaction, Relaxation Therapy

Intervention / Treatment
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* Other: Virtual Reality Immersive Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC 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 Patients who require deep sedation Patients who are deemed ineligible to approach by the surgeon

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Immersive Relaxation<br>Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. | Other: Virtual Reality Immersive Relaxation<br>* The software developed by VRHealth allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.<br>|
| No Intervention: Usual Anesthesia Care<br>Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Propofol Dose | Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure. | Duration of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, an average of 30 minutes | 
| Morphine Equivalent Dose | The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (milligrams). | Duration of the patient's stay in the post anesthesia care unit, an average of 30 minutes | 
| Pain assessed by Eleven Point Numerical Rating Scale | Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome). | Day of surgery to time of discharge from the post anesthesia care unit, an average of 30 minutes | 
| Patient Satisfaction Measured Using Overall Study Rating Score | Patient satisfaction will be assessed using a survey which asks about ease of use, programming preferences and overall study satisfaction. The total satisfaction score will be reported on a scale from 0 (worst outcome; very unsatisfied) to 100 (best outcome; very satisfied). | Day of surgery up to 1 month postoperatively |