The Virtual Reality in the Operating Room (VR-OR) trial is a randomized, controlled, single-center clinical trial of adult orthopedic surgical patients undergoing upper extremity surgery. Individuals will be randomized in a 1:1 allocation to either undergo immersion relaxation via the intraoperative use of VR or usual care control. The primary outcome of this study will be the difference in intraoperative propofol dose between groups. Secondary outcomes include postoperative analgesia dose requirements, postoperative pain scores, length of stay in the post-anesthesia care unit (PACU) and overall patient satisfaction. Additionally, at one month post-operatively, functional outcomes will be evaluated via a telephonic administration of the Disabilities of the Arm, Shoulder, and Hand (DASH) assessment. A study schema is provided in Figure 1.
This study is being conducted at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts. BIDMC is a 700-bed tertiary care academic facility which serves as a teaching hospital for Harvard Medical School. More than 1800 upper extremity orthopedic surgeries are performed at BIDMC per year.
Institutional Review Board (IRB) approval was obtained from the Committee on Clinical Investigations at BIDMC (IRB Protocol Number 2018-P–000398). This trial was registered on the National Institutes of Health (NIH) ClinicalTrials.gov website on 3 August 2018 with the identifier NCT03614325. Upon completion of the trial, results will be reported following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Standard Protocols Items: Recommendations for Interventional Trials (SPIRIT) checklist. The trial is currently active and ongoing, and any amendments made to the protocol are reported to and approved by the BIDMC IRB.
Inclusion and exclusion criteria
Patients are deemed eligible for trial inclusion if they will undergo upper extremity surgery at BIDMC and receive regional anesthesia preoperatively according to standard practice. We will exclude patients who  are under 18 years of age;  have an active infection or open wounds of the face or eye area;  have a history of seizures of other symptoms linked to an epileptic condition;  plan to wear hearing aids during the surgical procedure;  have a pacemaker or other implanted medical device;  have droplet or airborne precautions;  have English-language limitations;  require deep sedation; or  are deemed ineligible to approach by the surgeon. Patients who do not speak English will be excluded, as clear verbal communication will be essential during the study procedures.
Following informed consent, patients are randomized in a 1:1 allocation using block randomization of equal sizes to either intraoperative VR immersion or usual care control. The Research Electronic Data Capture (REDCap) randomization module will be used to implement the study randomization schema prior to any study interventions taking place. REDCap is a secure, web-based application that supports data capture for research studies and allows customization to support the development of the electronic case report form (11). Considering the nature of the intervention, treatment allocation is unblinded.
After providing informed consent, the patient can voluntarily withdraw from the study. Additionally, if the anesthesia team or investigators determine that the patient is no longer eligible to participate as a result of cancelled surgery or meeting an exclusion criterion, the patient will be withdrawn from the study.
Study intervention: virtual reality immersive relaxation
Patients randomized to the VR immersion group will be asked to wear the VR headset and view the programming of their choice for the entire procedure as an adjunct to standard anesthesia practice. The software used in this study was created by VRHealth USA, and is designed to promote relaxation and calmness. Some of the immersive VR environments that have been created with the software include sitting on a beach, in a peaceful meadow or forest, or sitting on a mountaintop. In addition, a library of short videos is available for patients to view via a web-based user interface. A study team member will be available at all times intraoperatively to assist with the device programming and technical issues. An anesthesia provider will perform their usual clinical responsibilities, including closely monitoring the patient throughout the procedure, and is free to administer anesthetic medications if clinically necessary or when requested by the patient. Both the patient and the anesthesia provider can decline to continue with the VR programming at any time. This is not considered drop-out criteria and the patient’s results will be analyzed based on intention to treat. At the conclusion of the surgery, the VR headset will be removed and postoperative care will begin according to the current standard care practice.
Control arm: usual care
Patients randomized to the control group will undergo perioperative anesthesia according to the current standard care practice at BIDMC.
Clinical management in both groups
In both groups, patients will receive regional anesthesia preoperatively in accordance with standard practice. Per the discretion of the regional anesthesia team, patients may receive anxiolytic medications such as midazolam during the placement of the nerve block. All intraoperative anesthetic management and medication administration decisions will be determined by the treating provider. All patients will be monitored (vital signs and capnography) according to American Society of Anesthesiologist standards.
Multiple data points, including airway interventions and use of airway assist devices, will be abstracted from the anesthesia medical record.
To assess primary and secondary outcomes, data on intraoperative propofol dose, length of PACU stay, administration of post-operative analgesia, pain scores and patient satisfaction will be collected. Additionally, information regarding patient demographics (including, but not limited to, age, gender, race, body mass index and comorbidities), surgical characteristics, intraoperative vital signs, medication administration and post-operative outcome data will be reviewed from patients’ medical records. Postoperative pain scores, documented on a scale of 0 to 10 by nursing staff in the PACU, will be abstracted from the medical record. All study data will be stored anonymously and managed in a REDCap database hosted at BIDMC. The database is audited and monitored for timeliness, completeness and accuracy.
Reporting of compliance and adverse events
Since this study utilizes a non-invasive device, we expect the associated risks to be minimal. According to the device manufacturers, 1 in 4000 people experiencing VR may have severe dizziness, seizures, eye or muscle twitching, or blackouts triggered by light flashes. These symptoms are more common in children and young people (12). To mitigate these risks, we are excluding patients under 18 years of age and patients with a history of seizures from this study. This patient population is undergoing surgery and it is expected that they may have a number of unrelated adverse health events during their hospital course. Therefore, we will limit the scope of adverse event monitoring and reporting to those believed to be related to the study procedures. Subjects will be monitored for protocol compliance and occurrence of adverse events until the time of PACU discharge. If a subject experiences any symptoms, the VR programming will be stopped and the patient will be treated accordingly.