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| Name | Class |
|---|---|
| VRHealth Group Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Anesthesia Care | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Immersive Relaxation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Propofol Dose | Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Total Intraoperative Propofol Administered |
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Inclusion Criteria:
- Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian O'Gara, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31882015 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Virtual Reality Immersive Relaxation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Propofol Dose | Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure. | Posted | Median | Inter-Quartile Range | mg/kg/min | 60 minutes |
|
Adverse events were monitored from the start of the study; i.e. patient's surgery, until the time of a patient's PACU discharge. This timeframe typically encompasses 1-3 hours, all on the same day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian P. O'Gara | Beth Israel Deaconess Medical Center | 6177543189 | bpogara@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2018 | Jun 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D055191 | Delayed Emergence from Anesthesia |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Total propofol dose (mg bolus, mg infusion, and mg total) administered intraoperatively will be measured for the duration of the procedure. |
| 60 minutes |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Lost to Follow-up |
|
| Surgery never scheduled |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | BMI - Body Mass Index | Mean | Standard Deviation | Kg/m^2 |
|
| Diabetes | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Dyslipidemia | Count of Participants | Participants |
|
| Obesity | Count of Participants | Participants |
|
| COPD | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Anxiety | Count of Participants | Participants |
|
| Previous Use of VR | Count of Participants | Participants |
|
| Procedure Type | Multiple bookings per case are possible | Count of Participants | Participants |
|
| Surgery Length | Median | Inter-Quartile Range | minutes |
|
| Regional Anesthetic | Count of Participants | Participants |
|
| Regional Anesthetic | Median | Inter-Quartile Range | mg |
|
| Regional Anesthetic | Number of patients administered Midazolam for anxiolysis during the preoperative nerve block | Count of Participants | Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Median | Inter-Quartile Range | mg | 60 minutes |
|
|
|
| Secondary | Length of PACU Stay | The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes | Posted | Median | Inter-Quartile Range | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 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). | Modified intention to treat (those randomized who completed study protocol) | Posted | Median | Inter-Quartile Range | units on a scale | 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). | Posted | Median | Inter-Quartile Range | units on a scale | 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). | Posted | Median | Inter-Quartile Range | score on a scale, 0 - 100 | 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. | Posted | Median | Inter-Quartile Range | score on a scale, 0 - 100 | One month postoperatively |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| Ketorolac |
|
| Supplemental local block |
|
| Propofol total dose |
|
| I felt anxious |
|
| I remember being aware of how I felt in the OR |
|
| I would be interested in VR for future surgery |
|