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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040349 |
Receipt No. | R000046043 |
Scientific Title | Psychological and physical effects of self-isolation on Japanese school-aged children due to COVID19 epidemic |
Date of disclosure of the study information | 2020/05/11 |
Last modified on | 2020/11/18 |
Basic information | ||
Public title | Psychological and physical effects of self-isolation on Japanese school-aged children related to COVID19 epidemic | |
Acronym | Mental health on Japanese school-aged children related to COVID19 epidemic | |
Scientific Title | Psychological and physical effects of self-isolation on Japanese school-aged children due to COVID19 epidemic | |
Scientific Title:Acronym | Mental health on Japanese school-aged children related to COVID19 epidemic | |
Region |
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Condition | ||
Condition | Post traumatic stress disorder, depression | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Examinating the psychologicl and physical effects of Japanese school-aged children related to COVID19 epidemic |
Basic objectives2 | Others |
Basic objectives -Others | Asking to self-isolating Japanese school-aged children to fill out the quality-of-life questionnaire and five well-being index. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Five well-being index (WHO-5) |
Key secondary outcomes | Quality-of-life questionnaire |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
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 | All elementary and middle school children who visit to our outpatient clinic on April, May and October in 2020. | |||
Key exclusion criteria | Excluding the children who do not wish to attend this study, nor who do not answer the questionnaires | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Haga Red Cross Hospital | ||||||
Division name | Pediatrics | ||||||
Zip code | 3214306 | ||||||
Address | 271 Nakagou, Mouka, Tochigi | ||||||
TEL | 0285822195 | ||||||
mari.saito@haga.jrc.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Haga Red Cross Hospital | ||||||
Division name | Pediatrics | ||||||
Zip code | 3214306 | ||||||
Address | 271 Nakago Mouka Tochigi | ||||||
TEL | 0285822195 | ||||||
Homepage URL | |||||||
mari.saito@haga.jrc.or.jp |
Sponsor | |
Institute | Haga Red Cross Hospital |
Institute | |
Department |
Funding Source | |
Organization | Pediatrics reserach funding in Haga Red Cross Hospital |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Haga Red Cross Hospital Ethics Committee |
Address | 271 Nakago Mouka Tochigi |
Tel | 0285822195 |
mari.saito@haga.jrc.or.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | R2-10 |
Org. issuing International ID_1 | Haga Red Cross Hospital Ethics Committee |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information | At the end of the self-isolation period, we will analyze the questionnaire, WHO-5 and other related data. |
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=R000046043 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |