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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040567
Receipt No. 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 2021/05/31

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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
Email 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
Email marisame@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2022 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
2021 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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