UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040567 |
|---|---|
| Receipt number | R000046302 |
| Scientific Title | Investigation of efficacy and safety of yoga in school non-attendance children - a multicenter open cluster randomized controlled trial |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2022/05/30 10:11:58 |
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Basic information
Public title
Investigation of efficacy and safety of yoga in school non-attendance children
Acronym
yoga study
Scientific Title
Investigation of efficacy and safety of yoga in school non-attendance children - a multicenter open cluster randomized controlled trial
Scientific Title:Acronym
yoga study
Region
| Japan |
Condition
Condition
school refusal students
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to examine whether yoga intervention in children who refuse to go to school could control their feelings of anxiety. We will demonstrate that yoga intervention helps non-attending school children control their feelings of anxiety and will develop a treating method that is very safe and reliable for children who refuse to go to school. This study will show that yoga is a comprehensive, effective, and very safe intervention for children who refuse to go to school.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SCAS-C score after 29 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
yoga intervention
Interventions/Control_2
non-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
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
school non-attendance children
Key exclusion criteria
1)Fulll IQ is 70 or less
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Amitani |
Organization
Kagoshima University
Division name
Research Field in Medicine and Health Sciences, Medical and Dental Sciences Area
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima
TEL
099-275-6898
marisame@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Amitani |
Organization
Kagoshima University
Division name
Research Field in Medicine and Health Sciences, Medical and Dental Sciences Area
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima
TEL
099-275-6898
Homepage URL
marisame@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Clinical Research Manegement Center, Kagoshima University Hospital
Address
8-35-1, Sakuragaoka, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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
| 2020 | Year | 06 | Month | 01 | 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
| 2020 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 05 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046302
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
