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Trial record 3 of 13 for:    virtual reality | ( Map: Massachusetts, United States )

Virtual Reality in the Operating Room (OR-VR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614325
Recruitment Status : Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
VRHealth Group Ltd
Information provided by (Responsible Party):
Brian O'Gara, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Intravenous Pain, Postoperative Delayed Recovery From Anesthesia Satisfaction Relaxation Therapy Other: Virtual Reality Immersive Relaxation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : November 7, 2019
Estimated Study Completion Date : September 1, 2020

Arm Intervention/treatment
Experimental: 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.

Other: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Intraoperative Propofol Dose [ Time Frame: Duration of the procedure ]
    Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.


Secondary Outcome Measures :
  1. Length of PACU Stay [ Time Frame: Duration of the patient's stay in the post anesthesia care unit, an average of 30 minutes ]
    The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes

  2. Morphine Equivalent Dose [ Time Frame: Duration of the patient's stay in the post anesthesia care unit, an average of 30 minutes ]
    The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams).

  3. Pain assessed by Eleven Point Numerical Rating Scale [ Time Frame: Day of surgery to time of discharge from the post anesthesia care unit, an average of 30 minutes ]
    Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).

  4. Patient Satisfaction Measured Using Overall Study Rating Score [ Time Frame: Day of surgery up to 1 month postoperatively ]
    Patient satisfaction will be assessed using a survey which asks about ease of use, programming preferences and overall study satisfaction. The total satisfaction score will be reported on a scale from 0 (worst outcome; very unsatisfied) to 100 (best outcome; very satisfied).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614325


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
VRHealth Group Ltd
Investigators
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Principal Investigator: Brian O'Gara, MD Beth Israel Deaconess Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian O'Gara, Attending Anesthesiologist, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03614325    
Other Study ID Numbers: 2018P000398
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs