Virtual Reality in the Operating Room (OR-VR)

• ClinicalTrials.gov Identifier: NCT03614325
• Recruitment Status: Unknown
• First Posted: August 3, 2018
• Last Update Posted: January 27, 2021
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: VRHealth Group Ltd
• Information provided by (Responsible Party): Brian O'Gara, Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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).
3. 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).
4. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

VRHealth Group Ltd

Investigators

• Principal Investigator: Brian O'Gara, MD; Beth Israel Deaconess Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Faruki A, Nguyen T, Proeschel S, Levy N, Yu J, Ip V, Mueller A, Banner-Goodspeed V, O'Gara B. Virtual reality as an adjunct to anesthesia in the operating room. Trials. 2019 Dec 27;20(1):782. doi: 10.1186/s13063-019-3922-2.

• Responsible Party: Brian O'Gara, Attending Anesthesiologist, Principal Investigator, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03614325
• Other Study ID Numbers: 2018P000398
• First Posted: August 3, 2018
• 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

Additional relevant MeSH terms:

Pain, Postoperative; Delayed Emergence from Anesthesia; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations