Pain, Postoperative Clinical Trial
— OR-VROfficial title:
Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
Verified date | October 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 1, 2021 |
Est. primary completion date | November 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | VRHealth Group Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative Propofol Dose | Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure. | 60 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. | 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. | 60 minutes | |
Secondary | 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 | |
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). | 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). | 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). | 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). | 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. | One month postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05480111 -
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
|
Phase 4 | |
Completed |
NCT06129305 -
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
|
||
Completed |
NCT04401826 -
Micro-surgical Treatment of Gummy Smile
|
N/A | |
Recruiting |
NCT04020133 -
the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.
|
N/A | |
Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT03546738 -
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
|
N/A | |
Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Terminated |
NCT03261193 -
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
|
Phase 3 | |
Completed |
NCT02525133 -
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
|
Phase 3 | |
Completed |
NCT03244540 -
Regional Analgesia After Cesarean Section
|
Phase 4 | |
Enrolling by invitation |
NCT05316168 -
Post Operative Pain Management for ACL Reconstruction
|
Phase 3 | |
Recruiting |
NCT04130464 -
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
|
Phase 4 | |
Enrolling by invitation |
NCT04574791 -
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04073069 -
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
|
Phase 4 | |
Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
Recruiting |
NCT05351229 -
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
|
Phase 4 | |
Enrolling by invitation |
NCT05543109 -
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
|
N/A | |
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 |