Trial Outcomes & Findings for Virtual Reality in the Operating Room (NCT NCT03614325)

NCT ID: NCT03614325

Last Updated: 2024-04-08

Results Overview

Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 60 minutes
• Results posted on: 2024-04-08

Participant Flow

Participant milestones

Measure	Usual Anesthesia Care Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Overall Study STARTED	20	20
Overall Study Completed Intervention	17	17
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Measure	Usual Anesthesia Care Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Overall Study Withdrawal by Subject	0	2
Overall Study Surgery Cancelled	2	1
Overall Study Lost to Follow-up	2	1
Overall Study Surgery never scheduled	1	0

Baseline Characteristics

Virtual Reality in the Operating Room

Baseline characteristics by cohort

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.	Total n=34 Participants Total of all reporting groups
Age, Continuous	50.1 years STANDARD_DEVIATION 11.1 • n=5 Participants	48.7 years STANDARD_DEVIATION 19.0 • n=7 Participants	49.4 years STANDARD_DEVIATION 0.09 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	28.7 Kg/m^2 STANDARD_DEVIATION 5.2 • n=5 Participants	28.1 Kg/m^2 STANDARD_DEVIATION 4.8 • n=7 Participants	28.4 Kg/m^2 STANDARD_DEVIATION .12 • n=5 Participants
Diabetes	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Hypertension	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Dyslipidemia	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Obesity	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
COPD	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Depression	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Anxiety	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Previous Use of VR Never	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Previous Use of VR Once	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Previous Use of VR A few times	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Previous Use of VR Many times	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Procedure Type Carpal Tunnel	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Procedure Type Dupuytren's contracture	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Procedure Type Tendon/ligament repair	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Procedure Type Ganglion removal	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Procedure Type Ulnar neurolysis/decompression	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Procedure Type Mass/cyst excision	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Procedure Type Reduction and/or internal fixation	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Procedure Type Other	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Surgery Length	27.0 minutes n=5 Participants	19.0 minutes n=7 Participants	23 minutes n=5 Participants
Regional Anesthetic Supraclavicular	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Regional Anesthetic Infraclavicular	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Regional Anesthetic None/data missing	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Regional Anesthetic Bupivacaine	100 mg n=5 Participants	100 mg n=7 Participants	100 mg n=5 Participants
Regional Anesthetic Mepivacaine	240 mg n=5 Participants	200 mg n=7 Participants	220 mg n=5 Participants
Regional Anesthetic	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Intraoperative Propofol Dose	0.14 mg/kg/min Interval 0.12 to 0.21	0.00 mg/kg/min Interval 0.0 to 0.01

SECONDARY outcome

Timeframe: 60 minutes

Total dose of additional anesthetics (other than propofol) or analgesics administered intraoperatively will be measured for the duration of the procedure.

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Other Intraoperative Anesthetics or Analgesics Administered Ketamine	1 Participants	2 Participants
Other Intraoperative Anesthetics or Analgesics Administered Fentanyl	2 Participants	1 Participants
Other Intraoperative Anesthetics or Analgesics Administered Ketorolac	4 Participants	2 Participants
Other Intraoperative Anesthetics or Analgesics Administered Supplemental local block	1 Participants	7 Participants

SECONDARY outcome

Timeframe: 60 minutes

Total propofol dose (mg bolus, mg infusion, and mg total) administered intraoperatively will be measured for the duration of the procedure.

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Total Intraoperative Propofol Administered Protofol bolus	50 mg Interval 0.0 to 65.0	0 mg Interval 0.0 to 20.0
Total Intraoperative Propofol Administered Propofol infusion	223 mg Interval 162.0 to 384.0	0 mg Interval 0.0 to 0.0
Total Intraoperative Propofol Administered Propofol total dose	260 mg Interval 203.0 to 469.0	0 mg Interval 0.0 to 30.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Length of PACU Stay	75.0 minutes Interval 57.5 to 89.0	53.0 minutes Interval 43.0 to 72.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Pain Assessed by Eleven Point Numerical Rating Scale	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: PACU discharge

Population: Modified intention to treat (those randomized who completed study protocol)

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).

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Overall Patient Satisfaction	100 units on a scale Interval 100.0 to 100.0	92 units on a scale Interval 77.0 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Patient Survey: Agreement With the Following Statements (0-100) My pain was controlled	100 units on a scale Interval 100.0 to 100.0	100 units on a scale Interval 76.0 to 100.0
Patient Survey: Agreement With the Following Statements (0-100) I felt relaxed	100 units on a scale Interval 100.0 to 100.0	99 units on a scale Interval 79.0 to 100.0
Patient Survey: Agreement With the Following Statements (0-100) I felt anxious	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 30.0
Patient Survey: Agreement With the Following Statements (0-100) I remember being aware of how I felt in the OR	0 units on a scale Interval 0.0 to 0.0	97 units on a scale Interval 79.0 to 100.0
Patient Survey: Agreement With the Following Statements (0-100) I would be interested in VR for future surgery	100 units on a scale Interval 68.0 to 100.0	100 units on a scale Interval 69.0 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Hand Disability (QuickDASH)	40.9 score on a scale, 0 - 100 Interval 27.3 to 59.1	20.5 score on a scale, 0 - 100 Interval 9.1 to 40.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Usual Anesthesia Care n=17 Participants Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.	Virtual Reality Immersive Relaxation n=17 Participants Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. 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.
Difference Between Preoperative and Postoperative QuickDASH Scores	4.3 score on a scale, 0 - 100 Interval -11.4 to 16.9	7.9 score on a scale, 0 - 100 Interval -5.0 to 24.9

Adverse Events

Usual Anesthesia Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Virtual Reality Immersive Relaxation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian P. O'Gara

Beth Israel Deaconess Medical Center

Phone: 6177543189

Email: bpogara@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place