UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059276 |
|---|---|
| Receipt number | R000067804 |
| Scientific Title | The Effectiveness of Education for Parents and Coaches on the Physical Pain and Mental Health of Youth Athletes |
| Date of disclosure of the study information | 2025/10/04 |
| Last modified on | 2025/10/03 14:27:42 |
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Basic information
Public title
The Examination of the effectiveness of Health Education to Parents and Coaches for Youth Athletes
Acronym
Health Education to Parents and Coaches for Youth Athletes
Scientific Title
The Effectiveness of Education for Parents and Coaches on the Physical Pain and Mental Health of Youth Athletes
Scientific Title:Acronym
The Examination of the effectiveness of Health Education to Parents and Coaches for Youth Athletes
Region
| Japan |
Condition
Condition
Overuse injuries, Mental health issues
Classification by specialty
| Pediatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of educational intervention to parents and coaches who surround youth athletes on prevalence of overuse injuries and mental health issues.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of overuse injuries and mental health issues
Key secondary outcomes
Psychological resilience
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is 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
Delivery of educational content (article content) about once a week.
Interventions/Control_2
No intervention
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
| 10 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Individuals who are in the 5th or 6th grade at the start of the study.
- Individuals who participate in club team practices or games at least three times a week.
- Male individuals who play soccer, or female individuals who play basketball.
Key exclusion criteria
- Individuals who have left sports due to an injury or illness at the start of the study, and are not expected to return for at least 8 weeks (50% of the survey period).
- Individuals who regularly receive medical support.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Miwako |
| Middle name | |
| Last name | Yamanaka |
Organization
Euphoria Company, Limited
Division name
R&D Center
Zip code
102-0083
Address
10F Kojimachi Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo
TEL
050-1744-7921
miwako.yamanaka@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Yamanaka |
Organization
Euphoria Company, Limited
Division name
R&D Center
Zip code
102-0083
Address
10F Kojimachi Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo
TEL
050-1744-7921
Homepage URL
miwako.yamanaka@eu-phoria.jp
Sponsor or person
Institute
Euphoria Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Euphoria Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Euphoria Institutional Review Board
Address
10F Kojimachi Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo
Tel
050-1744-7921
info-rinri@eu-phoria.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 | 10 | Month | 04 | 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 | 09 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2026 | 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 | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067804
