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UMIN-CTR Clinical Trial |
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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 | 2020/11/27 |
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 |
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Condition | ||
Condition | school refusal students | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 | Kagoshima University |
Address | 8-35-1, Sakuragaoka, Kagoshima |
Tel | 099-275-6898 |
marisame@m3.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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |