Intraoperative stress and anxiety reduction with music therapy: A controlled randomized clinical trial of efficacy and safety

Objective: The purpose of this study was to investigate the music therapy (MT) effect in levels of intraoperative anxiety in patients undergoing crossectomy with stripping of the great saphenous vein and to assess the efficacy, safety, and feasibility of this alternative therapy as a complement of standard intraoperative care. Material and methods: The study is a simple blind, controlled, parallel groups, prospective randomized clinical trial. Patients were allocated by means of randomized controlled sampling. The study was performed in the surgery room of Getafe University Hospital in Madrid. The study was carried out in 40 patients, 20 randomized to the experimental group and 20 randomized to the control group, with an age range from 27 to 70 years. The control group was given intraoperative routine attention, and the experimental group was given an MT passive intervention that consisted of audition of musical fragments during varicose veins surgery. These pieces previously showed relaxing actions on the cardiovascular system. The anxiety levels were measured by means of pre- and postsurgical questionnaires by a blinded investigator for the study arm to which the patients had been randomized. Heart rate and systolic and diastolic blood pressures were determined during the intervention, and adrenaline and noradrenaline plasma levels were determined before and after the surgical procedure. Results: The majority of the patients in the MT group (95%) and standard care group (90%) completed the study. There were no statistical differences between the control and experimental groups in heart rate gradient or systolic and diastolic blood pressures measured after the intervention. The anxiety state and the stress feeling scale score after surgery were significantly inferior in the MT group (94.7% vs 57.9% decrease in anxiety levels, P < .05, and stress score of 1.31 vs 2.36, P < .05, respectively). The adverse events ratio was low and occurred with similar frequency in both groups. Conclusions: The MT intervention was easily implemented in the context of nursing care received during varicose vein surgery and was positively accepted and valued by the majority of the patients. MT is a safe procedure that is proved to reduce anxiety and stress in the study patients.