Passive Music Listening in Acute Cerebrovascular Disease

NCT ID: NCT06743412

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2025-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Regular music listening

Intervention Type: OTHER

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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

GIACOMO GIACALONE

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giacomo Giacalone, MD, PhD

Role: primary

Elena Papetti

Role: backup

Luisa Roveri, MD

Role: backup

Other Identifiers

MUSICSTROKE

Identifier Type: -

Identifier Source: org_study_id