Virtual Reality in the Operating Room

Not Applicable

Completed

Conditions: Pain, Postoperative
Anesthesia, Intravenous
Relaxation Therapy
Delayed Recovery From Anesthesia
Satisfaction

Registration Number: NCT03614325

Lead Sponsor: Beth Israel Deaconess Medical Center

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraoperative Propofol Dose	60 minutes	Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.

Secondary Outcome Measures

Name	Time	Method
Other Intraoperative Anesthetics or Analgesics Administered	60 minutes	Total dose of additional anesthetics (other than propofol) or analgesics administered intraoperatively will be measured for the duration of the procedure.
Total Intraoperative Propofol Administered	60 minutes	Total propofol dose (mg bolus, mg infusion, and mg total) administered intraoperatively will be measured for the duration of the procedure.
Length of PACU Stay	Duration of the patient's stay in the post anesthesia care unit, 100 minutes	The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes
Patient Survey: Agreement With the Following Statements (0-100)	PACU discharge	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).
Difference Between Preoperative and Postoperative QuickDASH Scores	One month postoperatively	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.
Pain Assessed by Eleven Point Numerical Rating Scale	Duration of stay in the post anesthesia care unit, 100 minutes	Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Overall Patient Satisfaction	PACU discharge	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).
Hand Disability (QuickDASH)	One month postoperatively	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).

Trial Locations

Locations (1): Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States