Effect of Music Listening on Stress in Acute Stroke

NCT05859841 | Unknown

• 1 other identifier: 34/1801/2017
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Keywords

Stroke; Music; stress

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (1)

• Leisure Activity Questionnaire

  6 months post-stroke

Study Arms (2)

Music listening

EXPERIMENTAL

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

Other: Music listening

Control

PLACEBO COMPARATOR

Standard treatment, care and rehabilitation

Other: Control

Interventions

Music listening OTHER

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

Music listening

Control OTHER

Standard treatment, care and rehabilitation

Control

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemispheric infarction
• Neurologically stable

You may not qualify if:

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

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Susanna Tuomaala

  Chief of Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 15 pt listen to music, 15 receives standard treatment, care and rehabilitation

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: May 16, 2023
• Study Start: August 21, 2017
• Primary Completion: June 16, 2019
• Study Completion: June 30, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)