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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03614325
Other study ID # 2018P000398
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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