Effect of Music Listening on Stress in Acute Stroke

Study Overview
=================
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.

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

Conditions
-----------------
Acute Stroke

Intervention / Treatment
-----------------
* Other: Music listening
* Other: Control


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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 15 pt listen to music, 15 receives standard treatment, care and rehabilitation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music listening<br>Music listening under instruction by music therapist, min 3 hours daily | Other: Music listening<br>* Music listening under instruction by music therapist, min 3 hours daily<br>|
| Placebo Comparator: Control<br>Standard treatment, care and rehabilitation | Other: Control<br>* Standard treatment, care and rehabilitation<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Music, stress