Acute StrokeMUSICSTROKENCT06743412
Passive Music Listening in Acute Cerebrovascular Disease
A study testing Regular music listening in people with Acute Stroke, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Regular music listening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jun 2022to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Ascolto Passivo di Musica Nella Malattia Cerebrovascolare Acuta
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.
Read more
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
- Being tested
- Regular music listening
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular music listeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline
Feasibility and acceptability during hospitalization (percentage of drop-outs).
percentage of drop-outs.
Measured: 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.
Measured: Baseline-discharge (up to 30 days)
Secondary outcomes (12)
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.
Measured: 3 months (+/- 1 month) follow-up visit
Improvement in the patient's perception of overall health status (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.
Measured: 3 months (+/- 1 month) follow-up visit
Feasibility and acceptability (percentage of drop-outs).
percentage of drop-outs
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: hospitalization phase (discharge-baseline, up to 30 days)
Daily average number of administrations of sedatives, anxiolytics, and antidepressants.
Measured: 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.
Measured: 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.
Measured: 3 months (+/- 1 month) follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start27 Jun 2022
- Primary completion25 Nov 2024
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIACOMO GIACALONE, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743412
- Sponsor's protocol ID
- MUSICSTROKE
- Acronym
- MUSICSTROKE
- Status last verified
- May 2025
- First submitted
- 4 Dec 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascolto Passivo di Musica Nella Malattia Cerebrovascolare Acuta
- ClinicalTrials.gov ID
- NCT06743412
- Acronym / sponsor ID
- MUSICSTROKE / MUSICSTROKE
- Conditions
- Acute Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGULAR MUSIC LISTENING | Experimental | Other: Regular music listeningPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular music listeningRegular listening of self-selected music sung in Italian language during the hospital stay and after discharge till the follow-up visit after 3 months. | Other | REGULAR MUSIC LISTENING |
Primary outcome
Improvement in anxiety/depression levels (HADS score) between baseline and discharge.
Time frame: Baseline vs. discharge (up to 30 days)
Hospital Anxiety and Depression Scale (HADS), total score ranges between 0-21, with higher values indicating higher levels of anxiety/depression.
Improvement in the patient's perception of overall health status between baseline and discharge (EQ-VAS).
Time frame: Baseline vs. discharge (up to 30 days)
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.
Feasibility and acceptability during hospitalization (Percentage of patients who refuse to participate in the study)
Time frame: Baseline
Percentage of patients who refuse to participate in the study
Feasibility and acceptability during hospitalization (percentage of drop-outs).
Time frame: Baseline-discharge (up to 30 days)
percentage of drop-outs.
Feasibility and acceptability during hospitalization (percentage of days and total hours of music listening during the hospitalization phase).
Time frame: Baseline-discharge (up to 30 days)
percentage of days and total hours of music listening during the hospitalization phase.
12 secondary outcomes
Improvement in anxiety/depression levels (HADS score)
Time frame: 3 months (+/- 1 month) follow-up visit
Improvement in the patient's perception of overall health status (EQ-VAS).
Time frame: 3 months (+/- 1 month) follow-up visit
Feasibility and acceptability (percentage of drop-outs).
Time frame: 3 months (+/- 1 month) follow-up visit
Evaluation of cognitive functions through MoCA test
Time frame: Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
Evaluation of cognitive functions through Stroop test
Time frame: Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
Evaluation of cognitive functions through delayed story recall
Time frame: 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).
Time frame: 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).
Time frame: Baseline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit
Blood pressure, pre- and post-listening.
Time frame: hospitalization phase (discharge-baseline, up to 30 days)
Daily average number of administrations of sedatives, anxiolytics, and antidepressants.
Time frame: hospitalization phase (discharge-baseline, up to 30 days)
Heart rate, pre- and post-listening.
Time frame: hospitalization phase (discharge-baseline, up to 30 days)
Feasibility and acceptability (percentage of days and total hours of music listening).
Time frame: 3 months (+/- 1 month) follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular music listening in people with Acute Stroke, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in anxiety/depression levels (HADS score) between baseline and discharge. (time frame: Baseline vs. discharge (up to 30 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.