Virtual Reality in the Operating Room (OR-VR)
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|ClinicalTrials.gov Identifier: NCT03614325|
Recruitment Status : Unknown
Verified January 2021 by Brian O'Gara, Beth Israel Deaconess Medical Center.
Recruitment status was: Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : January 27, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Anesthesia, Intravenous Pain, Postoperative Delayed Recovery From Anesthesia Satisfaction Relaxation Therapy||Other: Virtual Reality Immersive Relaxation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia|
|Actual Study Start Date :||December 4, 2018|
|Actual Primary Completion Date :||November 7, 2019|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: Virtual Reality Immersive Relaxation
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
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.
No Intervention: Usual Anesthesia Care
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.
- Intraoperative Propofol Dose [ Time Frame: Duration of the procedure ]Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.
- Length of PACU Stay [ Time Frame: Duration of the patient's stay in the post anesthesia care unit, an average of 30 minutes ]The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes
- Morphine Equivalent Dose [ Time Frame: Duration of the patient's stay in the post anesthesia care unit, an average of 30 minutes ]The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (milligrams).
- Pain assessed by Eleven Point Numerical Rating Scale [ Time Frame: Day of surgery to time of discharge from the post anesthesia care unit, an average of 30 minutes ]Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
- Patient Satisfaction Measured Using Overall Study Rating Score [ Time Frame: Day of surgery up to 1 month postoperatively ]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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614325
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Brian O'Gara, MD||Beth Israel Deaconess Medical Center|
|Responsible Party:||Brian O'Gara, Attending Anesthesiologist, Principal Investigator, Beth Israel Deaconess Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 3, 2018 Key Record Dates|
|Last Update Posted:||January 27, 2021|
|Last Verified:||January 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Delayed Emergence from Anesthesia