Acute StrokeMUKU3-1NCT05859841
Effect of Music Listening on Stress in Acute Stroke
A study testing Music listening in people with Acute Stroke, run by Turku University Hospital at 1 site in Finland.
Trial summary
Investigation on changes in the neurochemical stress parameters in acute stroke. 30 patients are recruited in the stroke unit, blood samples are collected at fixed intervals during the first two days. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Music listening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFinland
- Study dates
- 21 Aug 2017to 30 Jun 2023
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemispheric infarction
- Neurologically stable
Who cannot join
- Previous neurological disease affecting the outcome
- Previous psychiatric disease affecting the outcome
- Substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music Listening at Acute Stage of Stroke on the Recovery and Quality of Life: Block-randomized Controlled Study
Investigation on changes in the neurochemical stress parameters in acute stroke. 30 patients are recruited in the stroke unit, blood samples are collected at fixed intervals during the first two days. Patients are randomized to music listening and control.Neuropsychological testing is performed in the acute phase and 6 months post-stroke.
Read the detailed description
Outcome measures: NIHSS, stress hormone levels, questionnaires on mood and quality of life.
- Conditions
- Acute Stroke
- Being tested
- Music listening, Control
- Keywords
- Stroke, Music, stress
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningOther
Music listening under instruction by music therapist, min 3 hours daily
ControlOther
Standard treatment, care and rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Music listening | Experimental | Music listening under instruction by music therapist, min 3 hours daily Receives: Other: Music listening |
| Control | Placebo comparator | Standard treatment, care and rehabilitation Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety and Stress Scale
Change in Depression, Anxiety and Stress Scale scores
Measured: 1 day post-stroke
National Institute of Health Stroke Scale
Change in National Institute of Health Stroke Scale scores
Measured: 1 day post-stroke
Visual Analogue Mood Scale
Change in Visual Analogue Mood Scale scores
Measured: 2 days post stroke
Serum cortisol
Change in serum cortisol level
Measured: 2 days post-stroke
Serum C-reactive protein
Change in serum C-reactive protein level
Measured: 2 days post-stroke
Montreal Cognitive Assessment
Montreal Cognitive Assessment score
Measured: 3 days post-stroke
Blood pressure
Change in systolic/diastolic blood pressure
Measured: 3 days post-stroke
Pulse rate
Change in pulse rate
Measured: 3 days post-stroke
Depression, Anxiety and Stress Scale
Change in Depression, Anxiety and Stress Scale scores
Measured: 6 months post-stroke
National Institute of Health Stroke Scale
Change in National Institute of Health Stroke Scale
Measured: 6 months post-stroke
Visual Analogue Mood Scale
Change in Visual Analogue Mood Scale scores
Measured: 6 months post-stroke
Montreal Cognition Assessment
Change in Montreal Cognition Assessment score
Measured: 6 moths post-stroke
Stroke and Aphasia Quality of Life scale
Change in Stroke and Aphasia Quality of Life scale score
Measured: 6 months post-stroke
Center for Epidemiological Studies Depression score
Change in Center for Epidemiological Studies Depression score
Measured: 6 months post-stroke
Working Memory Questionnaire
Change in Working Memory Questionnaire score
Measured: 6 months post-stroke
Stroke Impact Scale
Change in Stroke Impact Scale score
Measured: 6 months post-stroke
Secondary outcomes (1)
Leisure Activity Questionnaire
Change in leisure activities (pre- vs. post-stroke)
Measured: 6 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start21 Aug 2017
- Primary completion16 Jun 2019
- Study completion30 Jun 2023 (estimated)
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.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 15 pt listen to music, 15 receives standard treatment, care and rehabilitation
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Seppo Soinila, Turku University Hospital
- Investigators
- Susanna Tuomaala, Study chair, Chief of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859841
- Sponsor's protocol ID
- 34/1801/2017
- Acronym
- MUKU3-1
- Status last verified
- May 2023
- First submitted
- 9 Jun 2017
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music Listening at Acute Stage of Stroke on the Recovery and Quality of Life: Block-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05859841
- Acronym / sponsor ID
- MUKU3-1 / 34/1801/2017
- Conditions
- Acute Stroke
- Keywords
- Stroke, Music, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Helsinki
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 May 2023 (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.
Investigation on changes in the neurochemical stress parameters in acute stroke. 30 patients are recruited in the stroke unit, blood samples are collected at fixed intervals during the first two days. Patients are randomized to music listening and control.Neuropsychological testing is performed in the acute phase and 6 months post-stroke.
Detailed description
Outcome measures: NIHSS, stress hormone levels, questionnaires on mood and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 15 pt listen to music, 15 receives standard treatment, care and rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Music listening | Experimental | Other: Music listeningMusic listening under instruction by music therapist, min 3 hours daily |
| Control | Placebo comparator | Other: ControlStandard treatment, care and rehabilitation |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemispheric infarction
- Neurologically stable
Key exclusion criteria (3 listed)
- Previous neurological disease affecting the outcome
- Previous psychiatric disease affecting the outcome
- Substance abuse
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 |
|---|---|---|
| Music listeningMusic listening under instruction by music therapist, min 3 hours daily | Other | Music listening |
| ControlStandard treatment, care and rehabilitation | Other | Control |
Primary outcome
Depression, Anxiety and Stress Scale
Time frame: 1 day post-stroke
Change in Depression, Anxiety and Stress Scale scores
National Institute of Health Stroke Scale
Time frame: 1 day post-stroke
Change in National Institute of Health Stroke Scale scores
Visual Analogue Mood Scale
Time frame: 2 days post stroke
Change in Visual Analogue Mood Scale scores
Serum cortisol
Time frame: 2 days post-stroke
Change in serum cortisol level
Serum C-reactive protein
Time frame: 2 days post-stroke
Change in serum C-reactive protein level
Montreal Cognitive Assessment
Time frame: 3 days post-stroke
Montreal Cognitive Assessment score
Blood pressure
Time frame: 3 days post-stroke
Change in systolic/diastolic blood pressure
Pulse rate
Time frame: 3 days post-stroke
Change in pulse rate
Depression, Anxiety and Stress Scale
Time frame: 6 months post-stroke
Change in Depression, Anxiety and Stress Scale scores
National Institute of Health Stroke Scale
Time frame: 6 months post-stroke
Change in National Institute of Health Stroke Scale
Visual Analogue Mood Scale
Time frame: 6 months post-stroke
Change in Visual Analogue Mood Scale scores
Montreal Cognition Assessment
Time frame: 6 moths post-stroke
Change in Montreal Cognition Assessment score
Stroke and Aphasia Quality of Life scale
Time frame: 6 months post-stroke
Change in Stroke and Aphasia Quality of Life scale score
Center for Epidemiological Studies Depression score
Time frame: 6 months post-stroke
Change in Center for Epidemiological Studies Depression score
Working Memory Questionnaire
Time frame: 6 months post-stroke
Change in Working Memory Questionnaire score
Stroke Impact Scale
Time frame: 6 months post-stroke
Change in Stroke Impact Scale score
1 secondary outcome
Leisure Activity Questionnaire
Time frame: 6 months post-stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Susanna Tuomaala study chair
Chief of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Acute Stroke, run by Turku University Hospital at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Depression, Anxiety and Stress Scale (time frame: 1 day post-stroke). The study lists 16 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 16 May 2023.