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Effect of Music Listening on Stress in Acute Stroke (MUKU3-1)

Primary Purpose

Acute Stroke

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Music listening
Control
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Stroke, Music, stress

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hemispheric infarction Neurologically stable Exclusion Criteria: Previous neurological disease affecting the outcome Previous psychiatric disease affecting the outcome Substance abuse

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Music listening

Control

Arm Description

Music listening under instruction by music therapist, min 3 hours daily

Standard treatment, care and rehabilitation

Outcomes

Primary Outcome Measures

Depression, Anxiety and Stress Scale
Change in Depression, Anxiety and Stress Scale scores
National Institute of Health Stroke Scale
Change in National Institute of Health Stroke Scale scores
Visual Analogue Mood Scale
Change in Visual Analogue Mood Scale scores
Serum cortisol
Change in serum cortisol level
Serum C-reactive protein
Change in serum C-reactive protein level
Montreal Cognitive Assessment
Montreal Cognitive Assessment score
Blood pressure
Change in systolic/diastolic blood pressure
Pulse rate
Change in pulse rate
Depression, Anxiety and Stress Scale
Change in Depression, Anxiety and Stress Scale scores
National Institute of Health Stroke Scale
Change in National Institute of Health Stroke Scale
Visual Analogue Mood Scale
Change in Visual Analogue Mood Scale scores
Montreal Cognition Assessment
Change in Montreal Cognition Assessment score
Stroke and Aphasia Quality of Life scale
Change in Stroke and Aphasia Quality of Life scale score
Center for Epidemiological Studies Depression score
Change in Center for Epidemiological Studies Depression score
Working Memory Questionnaire
Change in Working Memory Questionnaire score
Stroke Impact Scale
Change in Stroke Impact Scale score

Secondary Outcome Measures

Leisure Activity Questionnaire
Change in leisure activities (pre- vs. post-stroke)

Full Information

First Posted
June 9, 2017
Last Updated
May 5, 2023
Sponsor
Turku University Hospital
Collaborators
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT05859841
Brief Title
Effect of Music Listening on Stress in Acute Stroke
Acronym
MUKU3-1
Official Title
Effect of Music Listening at Acute Stage of Stroke on the Recovery and Quality of Life: Block-randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
June 16, 2019 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Stroke, Music, stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
15 pt listen to music, 15 receives standard treatment, care and rehabilitation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music listening
Arm Type
Experimental
Arm Description
Music listening under instruction by music therapist, min 3 hours daily
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Standard treatment, care and rehabilitation
Intervention Type
Other
Intervention Name(s)
Music listening
Intervention Description
Music listening under instruction by music therapist, min 3 hours daily
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard treatment, care and rehabilitation
Primary Outcome Measure Information:
Title
Depression, Anxiety and Stress Scale
Description
Change in Depression, Anxiety and Stress Scale scores
Time Frame
1 day post-stroke
Title
National Institute of Health Stroke Scale
Description
Change in National Institute of Health Stroke Scale scores
Time Frame
1 day post-stroke
Title
Visual Analogue Mood Scale
Description
Change in Visual Analogue Mood Scale scores
Time Frame
2 days post stroke
Title
Serum cortisol
Description
Change in serum cortisol level
Time Frame
2 days post-stroke
Title
Serum C-reactive protein
Description
Change in serum C-reactive protein level
Time Frame
2 days post-stroke
Title
Montreal Cognitive Assessment
Description
Montreal Cognitive Assessment score
Time Frame
3 days post-stroke
Title
Blood pressure
Description
Change in systolic/diastolic blood pressure
Time Frame
3 days post-stroke
Title
Pulse rate
Description
Change in pulse rate
Time Frame
3 days post-stroke
Title
Depression, Anxiety and Stress Scale
Description
Change in Depression, Anxiety and Stress Scale scores
Time Frame
6 months post-stroke
Title
National Institute of Health Stroke Scale
Description
Change in National Institute of Health Stroke Scale
Time Frame
6 months post-stroke
Title
Visual Analogue Mood Scale
Description
Change in Visual Analogue Mood Scale scores
Time Frame
6 months post-stroke
Title
Montreal Cognition Assessment
Description
Change in Montreal Cognition Assessment score
Time Frame
6 moths post-stroke
Title
Stroke and Aphasia Quality of Life scale
Description
Change in Stroke and Aphasia Quality of Life scale score
Time Frame
6 months post-stroke
Title
Center for Epidemiological Studies Depression score
Description
Change in Center for Epidemiological Studies Depression score
Time Frame
6 months post-stroke
Title
Working Memory Questionnaire
Description
Change in Working Memory Questionnaire score
Time Frame
6 months post-stroke
Title
Stroke Impact Scale
Description
Change in Stroke Impact Scale score
Time Frame
6 months post-stroke
Secondary Outcome Measure Information:
Title
Leisure Activity Questionnaire
Description
Change in leisure activities (pre- vs. post-stroke)
Time Frame
6 months post-stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hemispheric infarction Neurologically stable Exclusion Criteria: Previous neurological disease affecting the outcome Previous psychiatric disease affecting the outcome Substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Tuomaala
Organizational Affiliation
Chief of Research
Official's Role
Study Chair
Facility Information:
Facility Name
Turku University Hospital
City
Turku
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Music Listening on Stress in Acute Stroke

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