The aim of the study is to investigate whether passive music listening during the acute phase of stroke hospitalization is a feasible and acceptable intervention that can improve the patient's psychophysical well-being, reduce anxiety and depression indicators, and improve the patient's perception of their overall health status. Secondly, the effects during hospitalization on physiological parameters, pain perception, quality of sleep, and the use of sedative, antidepressant, or anxiolytic medications will be evaluated. Finally, it will be assessed whether passive music listening is also associated with an improvement in cognitive functions. The clinical trial is a prospective, randomized, controlled, open-label, single-center study with parallel cohorts. Subjects with acute cerebrovascular disease (ischemic stroke, hemorrhagic stroke) hospitalized in the Neurology-Stroke Unit at San Raffaele Hospital in Milan will be recruited. Enrolled subjects will be randomly assigned to 2 groups: * Group 1: regular music listening starting since the acute phase of hospitalization (between 24 and 96 hours after symptom onset), continuing post-discharge for a total of 3 months. * Group 2: no regular music listening. Measurements of psychophysical well-being, anxiety and depression scales, and cognitive functions will be performed at three different time points (baseline, discharge, and 3 months post-ischemic event during the routine follow-up visit as per standard care). The primary outcome of the study are: * To evaluate whether passive music listening during hospitalization is associated with an improvement in anxiety/depression levels as measured by the Hospital Anxiety and Depression Scale (HADS). * To investigate whether passive music listening during hospitalization is associated with an improvement in the patient's perception of their overall health status as measured by the Italian version of the EQ-VAS (EuroQol Visual Analog Scale). * To assess the feasibility and acceptability of the intervention by measuring the percentage of patients who refuse to participate in the study and the drop-out rate during the hospitalization phase, the percentage of days with music listening during hospitalization, and the total amount of listening hours; through a feasibility, acceptability, and care appreciation questionnaire.
Age range
18 Years – 85 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Improvement in anxiety/depression levels (HADS score) between baseline and discharge.
Timeframe: Baseline vs. discharge (up to 30 days)
Improvement in the patient's perception of overall health status between baseline and discharge (EQ-VAS).
Timeframe: Baseline vs. discharge (up to 30 days)
Feasibility and acceptability during hospitalization (Percentage of patients who refuse to participate in the study)
Timeframe: Baseline
Feasibility and acceptability during hospitalization (percentage of drop-outs).
Timeframe: Baseline-discharge (up to 30 days)
Feasibility and acceptability during hospitalization (percentage of days and total hours of music listening during the hospitalization phase).
Timeframe: Baseline-discharge (up to 30 days)