Virtual Reality in the Operating Room

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia, Intravenous Pain, Postoperative Delayed Recovery From Anesthesia Satisfaction Relaxation Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Virtual Reality Immersive Relaxation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No