Passive Music Listening in Acute Cerebrovascular Disease

NCT06743412 | Completed DMC

• 1 other identifier: MUSICSTROKE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• Improvement in anxiety/depression levels (HADS score)

  3 months (+/- 1 month) follow-up visit

• Improvement in the patient's perception of overall health status (EQ-VAS).

  3 months (+/- 1 month) follow-up visit

• Feasibility and acceptability (percentage of drop-outs).

  3 months (+/- 1 month) follow-up visit

• Evaluation of cognitive functions through MoCA test

  Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit

• Evaluation of cognitive functions through Stroop test

  Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit

Study Arms (2)

REGULAR MUSIC LISTENING

EXPERIMENTAL

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

NO REGULAR MUSIC LISTENING

NO INTERVENTION

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.

Interventions

Regular music listening 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.

REGULAR MUSIC LISTENING

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 19, 2024
• Study Start: June 27, 2022
• Primary Completion: November 25, 2024
• Study Completion: February 27, 2025
• Last Updated: March 17, 2026

Record last verified: 2025-05

Locations

IT (1)