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OpenTrials
Completed

NCT Number: NCT03614325

Virtual Reality in the Operating Room

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.

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Key information

Conditions

Anesthesia, Intravenous Behavior Delayed Emergence from Anesthesia Delayed Recovery From Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Postoperative Complications Relaxation Therapy Satisfaction Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intraoperative Propofol Dose

    Time frame: 60 minutes

    Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.

Secondary outcomes

  1. Other Intraoperative Anesthetics or Analgesics Administered

    Time frame: 60 minutes

    Total dose of additional anesthetics (other than propofol) or analgesics administered intraoperatively will be measured for the duration of the procedure.

  2. Total Intraoperative Propofol Administered

    Time frame: 60 minutes

    Total propofol dose (mg bolus, mg infusion, and mg total) administered intraoperatively will be measured for the duration of the procedure.

  3. Length of PACU Stay

    Time frame: 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

  4. Pain Assessed by Eleven Point Numerical Rating Scale

    Time frame: 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).

  5. Overall Patient Satisfaction

    Time frame: 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).

  6. Patient Survey: Agreement With the Following Statements (0-100)

    Time frame: 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).

  7. Hand Disability (QuickDASH)

    Time frame: 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).

  8. Difference Between Preoperative and Postoperative QuickDASH Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • VRHealth Group Ltd

Registry information

Official study title

Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia

Acronym: OR-VR

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Aug 3, 2018
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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