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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 : September 17, 2020
Sponsor:
Collaborator:
VRHealth Group Ltd
Information provided by (Responsible Party):
Brian O'Gara, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE July 9, 2018
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE December 4, 2018
Actual Primary Completion Date November 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
Intraoperative Propofol Dose [ Time Frame: Duration of the procedure ]
Total propofol dose (mcg/kg/min) administered intraoperatively will be measured for the duration of the procedure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • 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
  • 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 (milligrams).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • 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
  • 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).
  • 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).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality in the Operating Room
Official Title  ICMJE Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anesthesia, Intravenous
  • Pain, Postoperative
  • Delayed Recovery From Anesthesia
  • Satisfaction
  • Relaxation Therapy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Virtual Reality Immersive 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Actual Primary Completion Date November 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03614325
Other Study ID Numbers  ICMJE 2018P000398
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian O'Gara, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE VRHealth Group Ltd
Investigators  ICMJE
Principal Investigator: Brian O'Gara, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP