UMIN-CTR Clinical Trial

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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