Objective: Music can be used as an alternative method to decrease anxiety in awake patients during surgical procedures. The aim of this study was to test the hypothesis that listening to music during carotid endarterectomy (CEA) under regional anesthesia decreases the patient's anxiety and pain. Design: A multicenter, prospective, randomized controlled trial. Setting: Patients undergoing carotid endarterectomy under cervical plexus block. Interventions: Patients scheduled for carotid endarterectomy under cervical plexus block were randomized into two groups: Music Group and Control Group. Main Outcome Measures: The primary endpoint of this study was the difference in intraoperative anxiety in patients with or without music during CEA under regional anesthesia, and the secondary endpoints were intraoperative and postoperative pain, use of additional local anesthetics, use of intravenous analgesics, patient and surgeon satisfaction and complications. Anxiety was assessed using State Trait Anxiety Inventory (STAI) and numeric rating scale (NRS). Visual analog scale (VAS) was used for pain assessment. Results: The postoperative STAI scores were similar in both groups (p = 0.839). The NRS scores measured immediately after the end of the surgery were statistically higher in Music Group (p = 0.001). The intraoperative anxiety statistically increased in Music Group, when the scores of the intraoperative responses to the questions of "are you relaxed?" and "are you calm?" were compared. (p = 0.0001 and p = 0.0001, respectively). There were no statistical differences in terms of the amount of intraoperative and postoperative analgesic used (p = 0.801, p = 0.773, respectively). The intraoperative VAS scores, postoperative VAS scores, patient and surgeon satisfaction scores were similar in both groups (p = 0.586, p = 0.185, p = 0.302 and p = 0.599, respectively). Systolic, diastolic and mean arterial blood pressure and heart rate were no different between Music Group and Control Group at any of all time points during the intraoperative period. Surgical side and contralateral side cerebral rSO2 values are similar in both groups (p = 0.438, p = 0.397, respectively). Conclusions: Music use in CEA under regional anesthesia increased intraoperative patient anxiety, and had no effect on intraoperative and postoperative pain or patient satisfaction.
