Abstract
BACKGROUND: Surgery and anesthesia are associated with heightened anxiety, particularly in procedures performed under regional anesthesia where patients remain conscious. Perioperative anxiety can negatively affect hemodynamic stability, patient satisfaction, and overall recovery. Immersive virtual reality (VR) has emerged as a promising non-pharmacological intervention to manage intraoperative anxiety. OBJECTIVES: This study aimed to examine the effect of VR on intraoperative anxiety (primary endpoint), stress levels, and patient satisfaction (secondary endpoints) in Palestinian patients undergoing urological surgery under regional anesthesia. METHODS: A total of 145 patients undergoing elective urological surgery under spinal or epidural anesthesia at Rafidia Governmental Hospital, Palestine, were enrolled in this assessor-blinded randomized controlled trial between June and September 2024. Participants were randomly assigned to a VR group (n = 72) or control group (n = 73). The primary endpoint was intraoperative anxiety measured using the State-Trait Anxiety Inventory (STAI) at 30 min post-induction. Secondary endpoints included stress (Perceived Stress Scale), patient satisfaction (Visual Analog Scale), and hemodynamic parameters. RESULTS: The VR group demonstrated significantly lower intraoperative anxiety scores compared to the control group (37.2 ± 15.3 vs. 52.9 ± 15.7, P < 0.001, Cohen's d = 1.01). Secondary outcomes after Bonferroni correction (α = 0.0125) showed significantly lower stress levels (21.1 ± 5.3 vs. 25.9 ± 5.8, P < 0.001) and higher satisfaction scores (82.4 ± 12.1 vs. 61.3 ± 15.7, P < 0.001). Heart rate differences were not statistically significant after correction (85.5 ± 7.6 vs. 90.0 ± 7.8 bpm, P = 0.028). CONCLUSIONS: VR is a safe and effective non-pharmacological intervention that reduces intraoperative anxiety and stress while improving patient satisfaction in urological surgeries performed under regional anesthesia. These findings support VR integration into perioperative care protocols for procedures involving regional anesthesia. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov with identifier NCT07132216 on August 20, 2025.