Virtual Reality in the Operating Room

Pain, Postoperative Clinical Trial

— OR-VR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614325
• Other study ID #: 2018P000398
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2021
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Intravenous
• Delayed Emergence from Anesthesia
• Delayed Recovery From Anesthesia
• Pain, Postoperative
• Relaxation Therapy
• Satisfaction

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	VRHealth Group Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Propofol Dose	Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.	60 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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