Virtual Reality in the Operating Room (OR-VR)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Satisfaction; Anesthesia, Intravenous; Delayed Recovery From Anesthesia; Relaxation Therapy
• Intervention / Treatment: Other: Virtual Reality Immersive Relaxation

Detailed Description

The proposed study is a randomized, controlled trial to evaluate the effectiveness of VR as an adjunct to standard anesthetic practice for upper extremity surgery. Patients will be randomized to undergo immersion relaxation via the use of VR during their procedure or control. In both groups patients will undergo regional anesthesia preoperatively according to standard practice. Patients will then be assessed postoperatively to assess the intraoperative propofol dose between groups, as well as secondary outcomes including patient satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

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.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Intraoperative Anesthetics or Analgesics Administered	Total dose of additional anesthetics (other than propofol) or analgesics administered intraoperatively will be measured for the duration of the procedure.	60 minutes
Total Intraoperative Propofol Administered	Total propofol dose (mg bolus, mg infusion, and mg total) administered intraoperatively will be measured for the duration of the procedure.	60 minutes
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, 100 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).	Duration of stay in the post anesthesia care unit, 100 minutes
Overall Patient Satisfaction	Patient satisfaction will be assessed using a survey which asks about ease of use, programming preferences and overall study satisfaction. The satisfaction score will be reported on a scale from 0 (worst outcome; very unsatisfied) to 100 (best outcome; very satisfied).	PACU discharge
Patient Survey: Agreement With the Following Statements (0-100)	Patients are asked their level of agreement with statements about how well their pain was controlled, whether they felt anxious, whether they felt relaxed, whether they could remember their time in surgery, and whether they would be interested in using VR for another surgery. The total score will be reported on a scale from 0 (worst outcome, no agreement) to 100 (best outcome, total agreement).	PACU discharge
Hand Disability (QuickDASH)	As assessed by the Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score; a patient reported outcome scale regarding hand disability. Scores range from 0 (no disability) to 100 (most severe disability).	One month postoperatively
Difference Between Preoperative and Postoperative QuickDASH Scores	As assessed by the QuickDASH score, a patient reported outcome scale regarding hand disability. Higher scores indicate a patient's worse disability. This is to measure the difference in patient's disability before vs after their surgery.	One month postoperatively

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: VRHealth Group Ltd
• Investigators: Principal Investigator: Brian O'Gara, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): November 7, 2019
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Delayed Emergence from Anesthesia
• Other Study ID Numbers: 2018P000398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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