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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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). |
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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:
potentially able to continue music listening after discharge.
papable of giving informed consent for the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |