Study design
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.
Setting
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.
Study Registration
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 [1] are under 18 years of age; [2] have an active infection or open wounds of the face or eye area; [3] have a history of seizures of other symptoms linked to an epileptic condition; [4] plan to wear hearing aids during the surgical procedure; [5] have a pacemaker or other implanted medical device; [6] have droplet or airborne precautions; [7] have English-language limitations; [8] require deep sedation; or [9] 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. Patients will be approached preoperatively in the surgery clinic or via telephone. Patients will not be offered compensation for participation in the trial.
Randomization
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). Each patient is randomized via REDCap software after enrollment. The data manager will input the patient into REDCap after enrollment and determine which group the patient will be enrolled into. Randomization sequence is unknown to research members ahead of time. The allocation will only be informed to research members after the patient is enrolled and assigned. Considering the nature of the intervention, treatment allocation is unblinded, therefore, a protocol for unblinding participants is not applicable.
Drop-out criteria
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.
Data collection
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. There are no plans to prevent drop-outs or loss to follow up during the trial. 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.
Research team members met on a regular basis to discuss enrollment of patients. The data manager/statistician (AM) and data quality manager met regularly to assess and monitor the data quality. With a trial of this size and the low risk to participants, the study design team members did not feel it was necessary to have safety monitoring or steering committee. No interim analysis or trial audit will be performed during the trial. The trial is low risk for harm and therefore no post-trial care or compensation provisions are needed for trial participants experiencing harm from their participation.
Missing data from the perioperative course is not anticipated as the patients will undergo anesthesia with an anesthetic and medical record. If the patient is lost to follow-up 1 month post procedure then their data will not include DASH assessment information.
Analysis of secondary outcomes
Secondary outcomes including length of PACU stay, doses of medications administered and pain scores will be expressed as continuous variables. Secondary outcomes with continuous variables will be assessed using a t-test or Wilcoxon Rank Sum test to compare the two groups, depending on the normality of the data.
Doses of medications will be documented during PACU length of stay as either total milligrams dosed. Medications include dexmedetomidine, propofol, remifentanil, hydromorphone, fentanyl, midazolam, morphine, intravenous acetaminophen, ondansetron and ketorolac. The total dose of each medication given will be analyzed as a continuous variable.
Patient satisfaction will be evaluated from a REDCap survey using quantitative scales were used to assess the level of agreement with prompted statements in regards to pain, nausea, anxiety and overall experience, using slide bars with visible anchors of ‘strongly disagree’ (0), ‘neutral’ (50) and ‘strongly agree’ (100). The data from the survey will be used as continuous variables for analysis.
We will evaluate adherence to the randomization assignment, and should any patient receive an intervention different from their randomization assignment, a per protocol analysis will be performed as an additional secondary analysis. Therefore, the study team will analyze the patient for the intervention received instead of the randomization assignment. Functional success of the surgery will be assessed using the DASH questionnaire at one month post surgery and differences between groups will be analyzed (14).