Anesthesia, Intravenous, Delayed Recovery From Anesthesia, Pain, Postoperative, Relaxation Therapy, Satisfaction
Conditions
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.
Interventions
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.
Sponsors
VRHealth Group Ltd
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Propofol Dose | 60 minutes | Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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. |
| 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). |
| 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). |
| 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. |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Surgery Cancelled | 2 | 1 |
| Overall Study | Surgery never scheduled | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Usual Anesthesia Care | Total | Virtual Reality Immersive Relaxation |
|---|---|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 11.1 | 49.4 years STANDARD_DEVIATION 0.09 | 48.7 years STANDARD_DEVIATION 19 |
| Anxiety | 3 Participants | 5 Participants | 2 Participants |
| Body Mass Index | 28.7 Kg/m^2 STANDARD_DEVIATION 5.2 | 28.4 Kg/m^2 STANDARD_DEVIATION 0.12 | 28.1 Kg/m^2 STANDARD_DEVIATION 4.8 |
| COPD | 4 Participants | 7 Participants | 3 Participants |
| Depression | 6 Participants | 9 Participants | 3 Participants |
| Diabetes | 4 Participants | 6 Participants | 2 Participants |
| Dyslipidemia | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hypertension | 6 Participants | 15 Participants | 9 Participants |
| Obesity | 7 Participants | 10 Participants | 3 Participants |
| Previous Use of VR A few times | 1 Participants | 5 Participants | 4 Participants |
| Previous Use of VR Many times | 1 Participants | 1 Participants | 0 Participants |
| Previous Use of VR Never | 13 Participants | 23 Participants | 10 Participants |
| Previous Use of VR Once | 2 Participants | 5 Participants | 3 Participants |
| Procedure Type Carpal Tunnel | 4 Participants | 8 Participants | 4 Participants |
| Procedure Type Dupuytren's contracture | 1 Participants | 3 Participants | 2 Participants |
| Procedure Type Ganglion removal | 3 Participants | 6 Participants | 3 Participants |
| Procedure Type Mass/cyst excision | 3 Participants | 4 Participants | 1 Participants |
| Procedure Type Other | 4 Participants | 6 Participants | 2 Participants |
| Procedure Type Reduction and/or internal fixation | 2 Participants | 5 Participants | 3 Participants |
| Procedure Type Tendon/ligament repair | 5 Participants | 8 Participants | 3 Participants |
| Procedure Type Ulnar neurolysis/decompression | 2 Participants | 6 Participants | 4 Participants |
| Regional Anesthetic Bupivacaine | 100 mg | 100 mg | 100 mg |
| Regional Anesthetic Infraclavicular | 11 Participants | 19 Participants | 8 Participants |
| Regional Anesthetic Mepivacaine | 240 mg | 220 mg | 200 mg |
| Regional Anesthetic None/data missing | 2 Participants | 4 Participants | 2 Participants |
| Regional Anesthetic Supraclavicular | 4 Participants | 11 Participants | 7 Participants |
| Regional Anesthetic | 17 Participants | 30 Participants | 13 Participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 5 Participants |
| Sex: Female, Male Male | 9 Participants | 21 Participants | 12 Participants |
| Surgery Length | 27.0 minutes | 23 minutes | 19.0 minutes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Intraoperative Propofol Dose
Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.
Time frame: 60 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Anesthesia Care | Intraoperative Propofol Dose | 0.14 mg/kg/min |
| Virtual Reality Immersive Relaxation | Intraoperative Propofol Dose | 0.00 mg/kg/min |
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.
Time frame: One month postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Anesthesia Care | Difference Between Preoperative and Postoperative QuickDASH Scores | 4.3 score on a scale, 0 - 100 |
| Virtual Reality Immersive Relaxation | Difference Between Preoperative and Postoperative QuickDASH Scores | 7.9 score on a scale, 0 - 100 |
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).
Time frame: One month postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Anesthesia Care | Hand Disability (QuickDASH) | 40.9 score on a scale, 0 - 100 |
| Virtual Reality Immersive Relaxation | Hand Disability (QuickDASH) | 20.5 score on a scale, 0 - 100 |
Secondary
Length of PACU Stay
The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes
Time frame: Duration of the patient's stay in the post anesthesia care unit, 100 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Anesthesia Care | Length of PACU Stay | 75.0 minutes |
| Virtual Reality Immersive Relaxation | Length of PACU Stay | 53.0 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.
Time frame: 60 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Anesthesia Care | Other Intraoperative Anesthetics or Analgesics Administered | Ketamine | 1 Participants |
| Usual Anesthesia Care | Other Intraoperative Anesthetics or Analgesics Administered | Fentanyl | 2 Participants |
| Usual Anesthesia Care | Other Intraoperative Anesthetics or Analgesics Administered | Ketorolac | 4 Participants |
| Usual Anesthesia Care | Other Intraoperative Anesthetics or Analgesics Administered | Supplemental local block | 1 Participants |
| Virtual Reality Immersive Relaxation | Other Intraoperative Anesthetics or Analgesics Administered | Supplemental local block | 7 Participants |
| Virtual Reality Immersive Relaxation | Other Intraoperative Anesthetics or Analgesics Administered | Ketamine | 2 Participants |
| Virtual Reality Immersive Relaxation | Other Intraoperative Anesthetics or Analgesics Administered | Ketorolac | 2 Participants |
| Virtual Reality Immersive Relaxation | Other Intraoperative Anesthetics or Analgesics Administered | Fentanyl | 1 Participants |
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).
Time frame: PACU discharge
Population: Modified intention to treat (those randomized who completed study protocol)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Anesthesia Care | Overall Patient Satisfaction | 100 units on a scale |
| Virtual Reality Immersive Relaxation | Overall Patient Satisfaction | 92 units on a scale |
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).
Time frame: Duration of stay in the post anesthesia care unit, 100 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Anesthesia Care | Pain Assessed by Eleven Point Numerical Rating Scale | 0 units on a scale |
| Virtual Reality Immersive Relaxation | Pain Assessed by Eleven Point Numerical Rating Scale | 0 units on a scale |
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).
Time frame: PACU discharge
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Anesthesia Care | Patient Survey: Agreement With the Following Statements (0-100) | My pain was controlled | 100 units on a scale |
| Usual Anesthesia Care | 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 |
| Usual Anesthesia Care | Patient Survey: Agreement With the Following Statements (0-100) | I felt relaxed | 100 units on a scale |
| Usual Anesthesia Care | Patient Survey: Agreement With the Following Statements (0-100) | I would be interested in VR for future surgery | 100 units on a scale |
| Usual Anesthesia Care | Patient Survey: Agreement With the Following Statements (0-100) | I felt anxious | 0 units on a scale |
| Virtual Reality Immersive Relaxation | Patient Survey: Agreement With the Following Statements (0-100) | I would be interested in VR for future surgery | 100 units on a scale |
| Virtual Reality Immersive Relaxation | Patient Survey: Agreement With the Following Statements (0-100) | My pain was controlled | 100 units on a scale |
| Virtual Reality Immersive Relaxation | Patient Survey: Agreement With the Following Statements (0-100) | I felt anxious | 0 units on a scale |
| Virtual Reality Immersive Relaxation | Patient Survey: Agreement With the Following Statements (0-100) | I remember being aware of how I felt in the OR | 97 units on a scale |
| Virtual Reality Immersive Relaxation | Patient Survey: Agreement With the Following Statements (0-100) | I felt relaxed | 99 units on a scale |
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.
Time frame: 60 minutes
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Usual Anesthesia Care | Total Intraoperative Propofol Administered | Protofol bolus | 50 mg |
| Usual Anesthesia Care | Total Intraoperative Propofol Administered | Propofol infusion | 223 mg |
| Usual Anesthesia Care | Total Intraoperative Propofol Administered | Propofol total dose | 260 mg |
| Virtual Reality Immersive Relaxation | Total Intraoperative Propofol Administered | Protofol bolus | 0 mg |
| Virtual Reality Immersive Relaxation | Total Intraoperative Propofol Administered | Propofol infusion | 0 mg |
| Virtual Reality Immersive Relaxation | Total Intraoperative Propofol Administered | Propofol total dose | 0 mg |