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Virtual Reality in the Operating Room (OR-VR)

Primary Purpose

Anesthesia, Intravenous, Pain, Postoperative, Delayed Recovery From Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Immersive Relaxation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Intravenous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Immersive Relaxation

Usual Anesthesia Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intraoperative Propofol Dose
Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.

Secondary Outcome Measures

Length of PACU Stay
The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes
Morphine Equivalent Dose
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
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
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).

Full Information

First Posted
July 9, 2018
Last Updated
January 25, 2021
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
VRHealth Group Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03614325
Brief Title
Virtual Reality in the Operating Room
Acronym
OR-VR
Official Title
Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
VRHealth Group Ltd

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Intravenous, Pain, Postoperative, Delayed Recovery From Anesthesia, Satisfaction, Relaxation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Immersive Relaxation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Anesthesia Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Immersive Relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative Propofol Dose
Description
Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.
Time Frame
Duration of the procedure
Secondary Outcome Measure Information:
Title
Length of PACU Stay
Description
The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes
Time Frame
Duration of the patient's stay in the post anesthesia care unit, an average of 30 minutes
Title
Morphine Equivalent Dose
Description
The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (milligrams).
Time Frame
Duration of the patient's stay in the post anesthesia care unit, an average of 30 minutes
Title
Pain assessed by Eleven Point Numerical Rating Scale
Description
Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Time Frame
Day of surgery to time of discharge from the post anesthesia care unit, an average of 30 minutes
Title
Patient Satisfaction Measured Using Overall Study Rating Score
Description
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).
Time Frame
Day of surgery up to 1 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian O'Gara, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31882015
Citation
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.
Results Reference
derived

Learn more about this trial

Virtual Reality in the Operating Room

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