UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061682 |
|---|---|
| Receipt number | R000070575 |
| Scientific Title | Study of artistic creativity assessment in children using exercises. |
| Date of disclosure of the study information | 2026/05/25 |
| Last modified on | 2026/05/25 18:03:30 |
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Basic information
Public title
Study of artistic creativity assessment in children using exercises.
Acronym
Study of exercises and artistic creativity.
Scientific Title
Study of artistic creativity assessment in children using exercises.
Scientific Title:Acronym
Study of exercises and artistic creativity.
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of exercise on the artistic quality of artwork.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Art rating.
Key secondary outcomes
Cognitive task performance.
Autonomic nerve function.
Subjective sensation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The intervention involves performing exercises during the creation of artwork.
Interventions/Control_2
Providing instructions on the exercises only during the creation of artwork.
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
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who are in Grade 4 of elementary school through Grade 3 of junior high school and do not meet the exclusion criteria.
(2) Those who can understand the informed consent content and are able to provide written assent voluntarily, and whose parent or guardian is able to provide written informed consent.
Key exclusion criteria
(1) Individuals who have a history of serious neurological, cardiovascular, or other serious diseases, or who are currently undergoing treatment, including the use of prescription medications provided by a medical institution.
(2) Individuals who have a history of seizures related to neurological disorders, including episodes of loss of consciousness, coma, or convulsions.
(3) Individuals deemed unsuitable for participation in the study by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
Osaka Metropolitan University
Division name
Center for Health Science Innovation
Zip code
5588585
Address
3-3-138 Sugimoto, Sumiyoshi-ku, Osaka City, JAPAN
TEL
+81-6-6605-3432
gr-knky-chsi@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | MIZUNO |
Organization
Osaka Metropolitan University
Division name
Center for Health Science Innovation
Zip code
5588585
Address
3-3-138 Sugimoto, Sumiyoshi-ku, Osaka City, JAPAN
TEL
+81-6-6605-3432
Homepage URL
gr-knky-chsi@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University Center for Health Science Innovation
Institute
Department
Personal name
Funding Source
Organization
Shiga Support Center of Culture and Art for Next Generation.
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Center for Health Science Innovation Ethics Committee
Address
3-3-138 Sugimoto, Sumiyoshi-ku, Osaka City, JAPAN
Tel
+81-6-6605-3432
gr-knky-chsi@omu.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
| 2026 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 25 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070575
