OR-VR: Virtual Reality in the Operating Room

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03614325
Collaborator
VRHealth Group Ltd (Industry)
32
1
2
29.9
1.1

Study Details

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
  • Other: Virtual Reality Immersive Relaxation
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 4, 2018
Actual Primary Completion Date :
Nov 7, 2019
Anticipated Study Completion Date :
Jun 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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Aug 3, 2018
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Jan 27, 2021