Trial Design
anxiety
RECRUITMENT
This randomized clinical trial was approved by the institutional review board at the University of Miami. All participants provided verbal informed consent or assent. This study followed the Consolidated Standards of Reporting Trials (Participants were recruited from the University of Miami and included patients who were indicated to have an elective, outpatient orthopedic surgery with the senior author (L.D.K.). Recruitment began in November 2021, and the follow-up for the final patient was completed in October 2022.To investigate the effect of a preoperative AR training experience on patient anxiety, we randomized 140 patients to receive either the AR experience or the standard set of preoperative instructions as a control. The interactive AR experience was a custom application developed in-house in collaboration with our institution’s Center for Computational Science by Xennial Digital Studios. The AR intervention visually walks patients through their trip to the operating room with narration from their surgeon while using an AR headset. The development was funded by an institutional grant of $10 000 that covered the costs of the application design and development. The AR experience takes approximately 3 minutes. Inclusion criteria consisted of all patients aged 12 years or older who were scheduled to have an ambulatory procedure with our senior author. Patients were excluded if they did not speak English (as the AR application was recorded only in English) or if they had circumstances that would prevent them from meeting or performing study requirements, such as canceling surgery or not completing the required surveys. After patients were indicated for surgery and given a surgical date, verbal informed consent was obtained. Patients were then randomized into 1 of 2 groups (AR or control) using a randomization table by whoever was performing the enrollment (M.G.R, J.P.C., or D.L.) (