N/A
N=40
Virtual Reality in the Operating Room
Anesthesia, Intravenous · Pain, Postoperative · Delayed Recovery From Anesthesia · Satisfaction · Relaxation Therapy
Bottom Line
View on ClinicalTrials.gov: NCT03614325 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Intraoperative Propofol Dose — 0.14; 0.00 mg/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Reality Immersive Relaxation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Propofol Dose |
0.14; 0.00 | — |
| SECONDARY Other Intraoperative Anesthetics or Analgesics Administered |
1; 2; 2; 1; 4; 2 | — |
| SECONDARY Total Intraoperative Propofol Administered |
50; 0; 223; 0; 260; 0 | — |
| SECONDARY Length of PACU Stay |
75.0; 53.0 | — |
| SECONDARY Pain Assessed by Eleven Point Numerical Rating Scale |
0; 0 | — |
| SECONDARY Overall Patient Satisfaction |
100; 92 | — |
| SECONDARY Patient Survey: Agreement With the Following Statements (0-100) |
100; 100; 100; 99; 0; 0 | — |
| SECONDARY Hand Disability (QuickDASH) |
40.9; 20.5 | — |
| SECONDARY Difference Between Preoperative and Postoperative QuickDASH Scores |
4.3; 7.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03614325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.