Influence of Preoperative Virtual Reality on Preoperative State Anxiety in the Ambulatory Setting: The AMBLUMEEN Randomized Controlled Trial

BACKGROUND: Preoperative anxiety affects 30% to 80 % of ambulatory surgery patients and is associated with increased anesthetic requirements, postoperative pain, and delayed recovery. Virtual reality (VR) is a promising nonpharmacological anxiolytic, but evidence remains limited in the ambulatory setting. METHODS: The AMBLUMEEN (AMBulatory LUMEEN) trial is a single-center, randomized, open-label, superiority trial conducted in an adult ambulatory surgery unit. Patients with moderate-to-severe preoperative anxiety (State-Trait Anxiety Inventory Form Y-A [STAI-YA] > 45) were randomized 1:1 to standard care alone (control) or standard care and a single 20-minute preoperative VR session (immersive 360° natural contemplative scenes). The primary end point was the change in STAI-YA score from arrival in the ambulatory unit (baseline) to immediately before operating room transfer (presurgery), analyzed under the intention-to-treat principle with a linear mixed model. Secondary end points included preoperative benzodiazepine use, postoperative morphine requirement, unplanned overnight admission, patient satisfaction, and device acceptability. RESULTS: Of 106 randomized patients (53 per group) with a median [interquartile range] baseline STAI-YA of 49 [46-55] and 49 [46-58] respectively in the control and VR group, the VR group experienced a markedly greater reduction in state anxiety than controls. Adjusted mean between-group difference in STAI-YA change from baseline to presurgery was -18.7 95% confidence interval (CI) [-21.4 to -16.1] points in favor of VR. Although benzodiazepine requirement, postoperative pain, and unplanned overnight admission were comparable between groups, the morphine requirement in postanesthesia care unit was lower in the VR group (6/53 [11.3% 95% CI, 11.3 {4.3-23.0}] vs 0/53 [0.0%, 95% CI, {0.0-6.7}]; P = .027). Global perioperative satisfaction was high in both groups (median 8 [8-9] on 10). CONCLUSIONS: A single 20-minute session of medical-grade VR significantly reduced preoperative anxiety in ambulatory surgery patients, with high acceptability and an excellent safety profile.