Clinical trial NCT03614325: Virtual Reality in the Operating Room
Official title: Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Intravenous
Pain, Postoperative
Delayed Recovery From Anesthesia
Satisfaction
Relaxation Therapy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: VRHealth Group Ltd
First posted: 2018-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intraoperative Propofol Dose
timeFrame: 60 minutes
Secondary outcomes:
measure: Other Intraoperative Anesthetics or Analgesics Administered
timeFrame: 60 minutes
measure: Total Intraoperative Propofol Administered
timeFrame: 60 minutes
measure: Length of PACU Stay
timeFrame: Duration of the patient's stay in the post anesthesia care unit, 100 minutes
measure: Pain Assessed by Eleven Point Numerical Rating Scale
timeFrame: Duration of stay in the post anesthesia care unit, 100 minutes
measure: Overall Patient Satisfaction
timeFrame: PACU discharge
measure: Patient Survey: Agreement With the Following Statements (0-100)
timeFrame: PACU discharge
measure: Hand Disability (QuickDASH)
timeFrame: One month postoperatively
measure: Difference Between Preoperative and Postoperative QuickDASH Scores
timeFrame: One month postoperatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Brian O'Gara, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.