UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054750 |
|---|---|
| Receipt number | R000062566 |
| Scientific Title | Research on the effects of music therapy on emotions, cognitive function and physical behavior |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/06/24 18:23:08 |
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Basic information
Public title
Effects of music-based interventions on emotions, cognition and physical behavior
Acronym
Music-Cognition-Emotion-Behavior
Scientific Title
Research on the effects of music therapy on emotions, cognitive function and physical behavior
Scientific Title:Acronym
Music Therapy - Cognition, Emotion, Behavior
Region
| Japan |
Condition
Condition
1) Healthy adults
2) Patients diagnosed with mild cognitive impairment receiving outpatient rehabilitation treatment, those with vascular cognitive impairment hospitalized in a rehabilitation ward, or those hospitalized in a ward of a consciousness recovery center.
Classification by specialty
| Neurology | Geriatrics | Orthopedics |
| Neurosurgery | Cardiovascular surgery | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the effects of music intervention on emotions, cognition, physical behavior, and other factors will be examined from multiple perspectives in rehabilitation subjects with physical or cognitive impairments and healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale
Key secondary outcomes
1) Assessment of emotional intensity (e.g., pleasure, interest, activity, boredom, anger, sadness, surprise, fear, disgust, contempt) based on facial expression analysis.
2) Heart rate variability.
3) Assessment of participation and autonomy using reaction scales.
4) Behavioral analysis using videography.
5) Questionnaire survey on "points of change in the patient" regarding facial expressions and reactions during, before, and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
We will conduct an intervention using music (songs and orchestral music) with healthy adults and rehabilitation subjects with some kind of physical or cognitive impairment who are hospitalized or visit the rehabilitation department as outpatients. The study aims to examine whether the intervention results in changes in emotions, mood, and physical behavior.
The effectiveness of the intervention will be verified based on:
a) subjective evaluation of mood,
b) facial expression analysis,
c) heart rate variability, and
d) behavioral changes (including video recording, participation and autonomy surveys, and family questionnaire surveys) conducted before, during, and after the intervention.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy Adults:
Adults aged 18 years and over with no history of brain, neuromuscular, cardiac, or epileptic diseases, and who can give informed consent for this study are eligible.
2) Patients:
Patients who have been diagnosed with mild dementia and are undergoing outpatient rehabilitation treatment, or those with cerebrovascular cognitive impairment who are hospitalized in a rehabilitation ward. Patients must be 18 years of age or older and admitted to a ward of the Centre for the Recovery of Consciousness Disorders. They must be able to give informed consent to participate in this study after receiving a full explanation from the patient or a surrogate.
Key exclusion criteria
Exclude individuals with a history of brain disease, neuromuscular disease, cardiac disease, or epilepsy.
Exclude patients whose general condition is unstable and subject to sudden changes.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
4701192
Address
1-98, Kutsukake cho, Toyoake City, Aichi 470-1192
TEL
0562-93-2000
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
4701192
Address
1-98, Kutsukake cho, Toyoake City, Aichi 470-1192
TEL
0562-93-2000
Homepage URL
yootaka@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98, Kutsukake cho, Toyoake City, Aichi 470-1192
Tel
0562-93-2000
yootaka@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062566
