NCT06743412

Passive Music Listening in Acute Cerebrovascular Disease

Ascolto Passivo di Musica Nella Malattia Cerebrovascolare Acuta

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: IRCCS Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
OTHER	Regular music listening	Regular listening of self-selected music sung in Italian language during the hospital stay and after discharge till the follow-up visit after 3 months.

Timeline

• Start date: 2022-06-27
• Primary completion: 2024-11-25
• Completion: 2025-02-27
• First posted: 2024-12-19
• Last updated: 2026-03-17

Locations

1 site across 1 country: Italy