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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Stroke
• Intervention / Treatment: Other: Music listening; Other: Control

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hemispheric infarction
• Neurologically stable

Exclusion Criteria:

• Previous neurological disease affecting the outcome
• Previous psychiatric disease affecting the outcome
• Substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety and Stress Scale	Change in Depression, Anxiety and Stress Scale scores	1 day post-stroke
National Institute of Health Stroke Scale	Change in National Institute of Health Stroke Scale scores	1 day post-stroke
Visual Analogue Mood Scale	Change in Visual Analogue Mood Scale scores	2 days post stroke
Serum cortisol	Change in serum cortisol level	2 days post-stroke
Serum C-reactive protein	Change in serum C-reactive protein level	2 days post-stroke
Montreal Cognitive Assessment	Montreal Cognitive Assessment score	3 days post-stroke
Blood pressure	Change in systolic/diastolic blood pressure	3 days post-stroke
Pulse rate	Change in pulse rate	3 days post-stroke
Depression, Anxiety and Stress Scale	Change in Depression, Anxiety and Stress Scale scores	6 months post-stroke
National Institute of Health Stroke Scale	Change in National Institute of Health Stroke Scale	6 months post-stroke
Visual Analogue Mood Scale	Change in Visual Analogue Mood Scale scores	6 months post-stroke
Montreal Cognition Assessment	Change in Montreal Cognition Assessment score	6 moths post-stroke
Stroke and Aphasia Quality of Life scale	Change in Stroke and Aphasia Quality of Life scale score	6 months post-stroke
Center for Epidemiological Studies Depression score	Change in Center for Epidemiological Studies Depression score	6 months post-stroke
Working Memory Questionnaire	Change in Working Memory Questionnaire score	6 months post-stroke
Stroke Impact Scale	Change in Stroke Impact Scale score	6 months post-stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leisure Activity Questionnaire	Change in leisure activities (pre- vs. post-stroke)	6 months post-stroke

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Helsinki
• Investigators: Study Chair: Susanna Tuomaala, Chief of Research

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): June 16, 2019
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; stress; Music
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 34/1801/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No