Passive Music Listening in Acute Cerebrovascular Disease (MUSICSTROKE)

IRCCS Ospedale San Raffaele

Status: Enrolling

Conditions: Acute Stroke

Treatments: Other: Regular music listening

Study type: Interventional

Funder types: Other

Identifiers

NCT06743412

MUSICSTROKE

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

REGULAR MUSIC LISTENING

Experimental group

Description:

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.

Treatment:

Other: Regular music listening

NO REGULAR MUSIC LISTENING

No Intervention group

Description:

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.