Effect of Music Listening on Stress in Acute Stroke

Acute Stroke Clinical Trial

— MUKU3-1  

Official title:

Effect of Music Listening at Acute Stage of Stroke on the Recovery and Quality of Life: Block-randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05859841
• Other study ID #: 34/1801/2017
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 21, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Patients are randomized to music listening and control.Neuropsychological testing is performed in the acute phase and 6 months post-stroke.

Description:

Outcome measures: NIHSS, stress hormone levels, questionnaires on mood and quality of life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: June 30, 2023
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• Hemispheric infarction

• Neurologically stable

Exclusion Criteria:

• Previous neurological disease affecting the outcome

• Previous psychiatric disease affecting the outcome

• Substance abuse

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• Music listening
Music listening under instruction by music therapist, min 3 hours daily
• Control
Standard treatment, care and rehabilitation

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression, Anxiety and Stress Scale	Change in Depression, Anxiety and Stress Scale scores	1 day post-stroke
Primary	National Institute of Health Stroke Scale	Change in National Institute of Health Stroke Scale scores	1 day post-stroke
Primary	Visual Analogue Mood Scale	Change in Visual Analogue Mood Scale scores	2 days post stroke
Primary	Serum cortisol	Change in serum cortisol level	2 days post-stroke
Primary	Serum C-reactive protein	Change in serum C-reactive protein level	2 days post-stroke
Primary	Montreal Cognitive Assessment	Montreal Cognitive Assessment score	3 days post-stroke
Primary	Blood pressure	Change in systolic/diastolic blood pressure	3 days post-stroke
Primary	Pulse rate	Change in pulse rate	3 days post-stroke
Primary	Depression, Anxiety and Stress Scale	Change in Depression, Anxiety and Stress Scale scores	6 months post-stroke
Primary	National Institute of Health Stroke Scale	Change in National Institute of Health Stroke Scale	6 months post-stroke
Primary	Visual Analogue Mood Scale	Change in Visual Analogue Mood Scale scores	6 months post-stroke
Primary	Montreal Cognition Assessment	Change in Montreal Cognition Assessment score	6 moths post-stroke
Primary	Stroke and Aphasia Quality of Life scale	Change in Stroke and Aphasia Quality of Life scale score	6 months post-stroke
Primary	Center for Epidemiological Studies Depression score	Change in Center for Epidemiological Studies Depression score	6 months post-stroke
Primary	Working Memory Questionnaire	Change in Working Memory Questionnaire score	6 months post-stroke
Primary	Stroke Impact Scale	Change in Stroke Impact Scale score	6 months post-stroke
Secondary	Leisure Activity Questionnaire	Change in leisure activities (pre- vs. post-stroke)	6 months post-stroke