Clinical trial NCT06743412: Passive Music Listening in Acute Cerebrovascular Disease
Official title: Ascolto Passivo Di Musica Nella Malattia Cerebrovascolare Acuta
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Stroke
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Improvement in anxiety/depression levels (HADS score) between baseline and discharge.
timeFrame: Baseline vs. discharge (up to 30 days)
measure: Improvement in the patient's perception of overall health status between baseline and discharge (EQ-VAS).
timeFrame: Baseline vs. discharge (up to 30 days)
measure: Feasibility and acceptability during hospitalization (Percentage of patients who refuse to participate in the study)
timeFrame: Baseline
measure: Feasibility and acceptability during hospitalization (percentage of drop-outs).
timeFrame: Baseline-discharge (up to 30 days)
measure: Feasibility and acceptability during hospitalization (percentage of days and total hours of music listening during the hospitalization phase).
timeFrame: Baseline-discharge (up to 30 days)
Secondary outcomes:
measure: Improvement in anxiety/depression levels (HADS score)
timeFrame: 3 months (+/- 1 month) follow-up visit
measure: Improvement in the patient's perception of overall health status (EQ-VAS).
timeFrame: 3 months (+/- 1 month) follow-up visit
measure: Feasibility and acceptability (percentage of drop-outs).
timeFrame: 3 months (+/- 1 month) follow-up visit
measure: Evaluation of cognitive functions through MoCA test
timeFrame: Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
measure: Evaluation of cognitive functions through Stroop test
timeFrame: Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
measure: Evaluation of cognitive functions through delayed story recall
timeFrame: Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
measure: Patient perception of health status related to mobility, usual activities, anxiety, depression, and pain (EQ-5D-3L Italian version).
timeFrame: Baseline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up
measure: Patient perception of sleep quality (ISI insomnia severity index, Italian version).
timeFrame: Baseline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
measure: Blood pressure, pre- and post-listening.
timeFrame: hospitalization phase (discharge-baseline, up to 30 days)
measure: Daily average number of administrations of sedatives, anxiolytics, and antidepressants.
timeFrame: hospitalization phase (discharge-baseline, up to 30 days)
measure: Heart rate, pre- and post-listening.
timeFrame: hospitalization phase (discharge-baseline, up to 30 days)
measure: Feasibility and acceptability (percentage of days and total hours of music listening).
timeFrame: 3 months (+/- 1 month) follow-up visit
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: