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

• Sponsor: Turku University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05859841
• Collaborator: University of Helsinki (Other)
• Enrollment: 32
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 70.3
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke	Other: Music listening; Other: Control	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 15 pt listen to music, 15 receives standard treatment, care and rehabilitation15 pt listen to music, 15 receives standard treatment, care and rehabilitation
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Music Listening at Acute Stage of Stroke on the Recovery and Quality of Life: Block-randomized Controlled Study
• Actual Study Start Date: Aug 21, 2017
• Actual Primary Completion Date: Jun 16, 2019
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music listening Music listening under instruction by music therapist, min 3 hours daily	Other: Music listening; Music listening under instruction by music therapist, min 3 hours daily
Placebo Comparator: Control Standard treatment, care and rehabilitation	Other: Control; Standard treatment, care and rehabilitation

Outcome Measures

Primary Outcome Measures

1. Depression, Anxiety and Stress Scale [1 day post-stroke]

   Change in Depression, Anxiety and Stress Scale scores

2. National Institute of Health Stroke Scale [1 day post-stroke]

   Change in National Institute of Health Stroke Scale scores

3. Visual Analogue Mood Scale [2 days post stroke]

   Change in Visual Analogue Mood Scale scores

4. Serum cortisol [2 days post-stroke]

   Change in serum cortisol level

5. Serum C-reactive protein [2 days post-stroke]

   Change in serum C-reactive protein level

6. Montreal Cognitive Assessment [3 days post-stroke]

   Montreal Cognitive Assessment score

7. Blood pressure [3 days post-stroke]

   Change in systolic/diastolic blood pressure

8. Pulse rate [3 days post-stroke]

   Change in pulse rate

9. Depression, Anxiety and Stress Scale [6 months post-stroke]

   Change in Depression, Anxiety and Stress Scale scores

10. National Institute of Health Stroke Scale [6 months post-stroke]

    Change in National Institute of Health Stroke Scale

11. Visual Analogue Mood Scale [6 months post-stroke]

    Change in Visual Analogue Mood Scale scores

12. Montreal Cognition Assessment [6 moths post-stroke]

    Change in Montreal Cognition Assessment score

13. Stroke and Aphasia Quality of Life scale [6 months post-stroke]

    Change in Stroke and Aphasia Quality of Life scale score

14. Center for Epidemiological Studies Depression score [6 months post-stroke]

    Change in Center for Epidemiological Studies Depression score

15. Working Memory Questionnaire [6 months post-stroke]

    Change in Working Memory Questionnaire score

16. Stroke Impact Scale [6 months post-stroke]

    Change in Stroke Impact Scale score

Secondary Outcome Measures

1. Leisure Activity Questionnaire [6 months post-stroke]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hemispheric infarction

• Neurologically stable

Exclusion Criteria:

• Previous neurological disease affecting the outcome

• Previous psychiatric disease affecting the outcome

• Substance abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turku University Hospital	Turku		Finland

Sponsors and Collaborators

• Turku University Hospital
• University of Helsinki

Investigators

• Study Chair: Susanna Tuomaala, Chief of Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seppo Soinila, Professor, Turku University Hospital
• ClinicalTrials.gov Identifier: NCT05859841
• Other Study ID Numbers: 34/1801/2017
• First Posted: May 16, 2023
• Last Update Posted: May 16, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seppo Soinila, Professor, Turku University Hospital: Stroke; Music; stress
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 16, 2023