UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057658 |
|---|---|
| Receipt number | R000065505 |
| Scientific Title | A Study on the Effects of Instrumental Music on Attention Function |
| Date of disclosure of the study information | 2025/04/20 |
| Last modified on | 2025/11/02 13:07:00 |
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Basic information
Public title
A Study on the Effects of Instrumental Music on Attention Function
Acronym
A Study on the Effects of Instrumental Music on Attention Function
Scientific Title
A Study on the Effects of Instrumental Music on Attention Function
Scientific Title:Acronym
A Study on the Effects of Instrumental Music on Attention Function
Region
| Japan |
Condition
Condition
Developmental disorders
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how instrumental activities in music classes affect attentional functions, by use neuroscientific methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in NIRS (near-infrared spectroscopy) before and after instrumental music activities.
Key secondary outcomes
Changes in tests of attention function such as the Wisconsin Card Sorting Test (WCST).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Instrumental activities. Once,on the day of the experiment.
Interventions/Control_2
Activities other than instrumental music.Once,on the day of the experiment.
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have agreed to participate in this study.
Key exclusion criteria
Those with a history of organic brain disease such as epilepsy or cerebral infarction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Miura |
Organization
Fukushima Medical University, Department of medicine
Division name
Department of Neuropsychiatry
Zip code
960-1295
Address
1 Hikariga-oka,Fukushima City,Fukushima,JAPAN
TEL
024-547-1331
neuropsy@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Suzuki |
Organization
Fukushima Medical University,School of Medicine
Division name
Department of Neuropsychiatry
Zip code
960-1295
Address
1 Hikariga-oka,Fukushima City,Fukushima,JAPAN
TEL
024-547-1331
Homepage URL
neuropsy@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University, School of Medicine
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
Fukushima Medical University, School of Medicine
Address
1 Hikariga-oka,Fukushima City,Fukushima,JAPAN
Tel
024-547-1331
neuropsy@fmu.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
| 2025 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 04 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065505
