UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040349 |
|---|---|
| Receipt number | 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 | 2022/05/12 11:18:17 |
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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 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
| 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
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
mari.saito@haga.jrc.or.jp
Sponsor or person
Institute
Haga Red Cross Hospital
Institute
Department
Personal name
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
| 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
Completed
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 | 11 | Month | 11 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 11 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 11 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 12 | Day |
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
| 2022 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
