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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 2020/05/10

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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
Japan

Condition
Condition Post traumatic stress disorder, depression
Classification by specialty
Pediatrics
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
7 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria All elementary and middle school children who come to our outpatient clinic
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
1st name Mari
Middle name
Last name Saito
Organization Haga Red Cross Hospital
Division name Pediatrics
Zip code 3214306
Address 271 Nakagou, Mouka, Tochigi
TEL 0285822195
Email mari.saito@haga.jrc.or.jp

Public contact
Name of contact person
1st name Mari
Middle name
Last name Saito
Organization Haga Red Cross Hospital
Division name Pediatrics
Zip code 3214306
Address 271 Nakago Mouka Tochigi
TEL 0285822195
Homepage URL
Email 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
Email 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
2020 Year 05 Month 11 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 Enrolling by invitation
Date of protocol fixation
2020 Year 05 Month 10 Day
Date of IRB
2020 Year 05 Month 10 Day
Anticipated trial start date
2020 Year 05 Month 10 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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
2020 Year 05 Month 10 Day
Last modified on
2020 Year 05 Month 10 Day


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


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