UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047876 |
|---|---|
| Receipt number | R000054577 |
| Scientific Title | Creating a childcare support program based on the mother's class |
| Date of disclosure of the study information | 2022/05/27 |
| Last modified on | 2024/05/30 17:31:46 |
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Basic information
Public title
Creating a childcare support program based on the mother's class
Acronym
Creating a childcare support program based on the mother's class
Scientific Title
Creating a childcare support program based on the mother's class
Scientific Title:Acronym
Creating a childcare support program based on the mother's class
Region
| Japan |
Condition
Condition
puerperal women
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this program is to conduct interviews with mothers who visit the hospital for one-month postpartum checkups and create a childcare support program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative data obtained from interview surveys
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Puerperal women visiting the outpatient department of the Department of Obstetrics and Gynecology at Hamamatsu Medical University Hospital for a one-month postpartum checkup
(2) A person who was able to obtain consent for this research by signing a consent form by the principal
Key exclusion criteria
A person whom a doctor deems inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Yamasue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
TEL
053-435-2295
yamasue@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Fukumoto |
Organization
Hamamatsu University Hospital
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
TEL
053-435-2295
Homepage URL
yukofuku@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
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
The Institutional Review Board of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2022 | Year | 05 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Interviews will be conducted with puerperal women who come to the hospital for a one-month postpartum checkup. Collect qualitative data as indicators. The interviews will focus on "experience of being cared for," "relationship with parents," "image of parents," "image of one's own mother," "current child-rearing," "views and beliefs in child-rearing," and "how do you think that the experience of being raised affects one's own child-rearing?" Data is collected using semi-structured interviews and recordings. The interview lasted about 60 minutes.
Management information
Registered date
| 2022 | Year | 05 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054577
