Passive Music Listening in Acute Cerebrovascular Disease (MUSICSTROKE)

Ascolto Passivo di Musica Nella Malattia Cerebrovascolare Acuta

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.

Study Overview

• Status: Completed
• Conditions: Acute Stroke
• Intervention / Treatment: Other: Regular music listening

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• time of enrollment greater than 24 hours and less than 4 days from onset of acute cerebrovascular disease
• native Italian speaker

• able to cooperate according to the following criteria:

  • NIHSS stroke severity score at enrollment <10.
  • No impairment in alertness, orientation, or language that would prevent adequate communication (NIHSS score <2 for items 1a, 1b, 1c, 9, 10).
  • No known pre-existing severe or moderate cognitive decline (CDR<2).
• potentially able to continue music listening after discharge.
• papable of giving informed consent for the study.

Exclusion Criteria:

• Deafness and/or significant hearing loss and/or significant visual impairment and/or illiteracy.
• Major psychiatric illness.
• Other conditions that, in the investigator's judgment, would prevent compliance with the protocol during hospitalization or the post-hospitalization phase.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REGULAR MUSIC LISTENING; Patients randomized into this arm are provided with tablet and earphones for regular music listening during hospital stay (1 hour per day in average). After discharge, patients are instructed how to continue regular music listening till the follow-up visit. Patients are required to maintain a daily music listening diary to be presented at the follow-up visit.	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.
No Intervention: NO REGULAR MUSIC LISTENING; Patients randomized into this arm do not receive instrumentation for regular music listening during hospital stay. At discharge, patients in this arm are not required to perform regular music listening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in anxiety/depression levels (HADS score) between baseline and discharge.	Hospital Anxiety and Depression Scale (HADS), total score ranges between 0-21, with higher values indicating higher levels of anxiety/depression.	Baseline vs. discharge (up to 30 days)
Improvement in the patient's perception of overall health status between baseline and discharge (EQ-VAS).	EuroQol-visual analogue scales (EQ-VAS). The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.	Baseline vs. discharge (up to 30 days)
Feasibility and acceptability during hospitalization (Percentage of patients who refuse to participate in the study)	Percentage of patients who refuse to participate in the study	Baseline
Feasibility and acceptability during hospitalization (percentage of drop-outs).	percentage of drop-outs.	Baseline-discharge (up to 30 days)
Feasibility and acceptability during hospitalization (percentage of days and total hours of music listening during the hospitalization phase).	percentage of days and total hours of music listening during the hospitalization phase.	Baseline-discharge (up to 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in anxiety/depression levels (HADS score)	Hospital Anxiety and Depression Scale (HADS), total score ranges between 0-21, with higher values indicating higher levels of anxiety/depression.	3 months (+/- 1 month) follow-up visit
Improvement in the patient's perception of overall health status (EQ-VAS).	EuroQol-visual analogue scales (EQ-VAS). The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.	3 months (+/- 1 month) follow-up visit
Feasibility and acceptability (percentage of drop-outs).	percentage of drop-outs	3 months (+/- 1 month) follow-up visit
Evaluation of cognitive functions through MoCA test	MoCA (Montreal Cognitive Assessment or The MoCA Test) is a tool for early detection of mild cognitive impairment; total score ranges between 0 and 30, with lower values indicating increasing cognitive impairment.	Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
Evaluation of cognitive functions through Stroop test	The time interference score and the error interference score will be measured; according to normative data, the scores will be converted in equivalent scores from 0 to 4 with lower values indicating higher level of impairment.	Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
Evaluation of cognitive functions through delayed story recall	The raw score will be converted, according to normative data, to an equivalent score between 0 and 4 with lower values indicating more impairment.	Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
Patient perception of health status related to mobility, usual activities, anxiety, depression, and pain (EQ-5D-3L Italian version).	The EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) is a Patient Reported Outcomes (PRO) which examines five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The questionnaire produces a 5-digit health state profile that represents the level of reported problems on each of the five dimensions of health. EQ-5D 5-digit health state is subsequently converted into a single index value, according to normative, which reflects the health state.	Baseline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up
Patient perception of sleep quality (ISI insomnia severity index, Italian version).	The total score ranges from 0 to 28, with higher score indicating greater insomnia severity.	Baseline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
Blood pressure, pre- and post-listening.	Blood pressure, pre- and post-listening to music. Measure unit: mmHg	hospitalization phase (discharge-baseline, up to 30 days)
Daily average number of administrations of sedatives, anxiolytics, and antidepressants.		hospitalization phase (discharge-baseline, up to 30 days)
Heart rate, pre- and post-listening.	Heart rate, pre- and post-listening to music. Measure unit: beats/min.	hospitalization phase (discharge-baseline, up to 30 days)
Feasibility and acceptability (percentage of days and total hours of music listening).	percentage of days and total hours of music listening.	3 months (+/- 1 month) follow-up visit

Collaborators and Investigators

• Sponsor: IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: MUSICSTROKE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No