UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058989 |
|---|---|
| Receipt number | R000067461 |
| Scientific Title | Social support contributes to preventing postpartum depressive symptoms of Vietnamese women in Japan: A qualitative research |
| Date of disclosure of the study information | 2025/09/08 |
| Last modified on | 2025/09/04 11:15:59 |
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Basic information
Public title
Experience of pregnancy, childbirth, and child-rearing in Vietnamese women living in Japan, and Social support contribute to preventing postpartum depressive symptoms in them
Acronym
Social support contributes to preventing postpartum depressive symptoms of Vietnamese women in Japan
Scientific Title
Social support contributes to preventing postpartum depressive symptoms of Vietnamese women in Japan: A qualitative research
Scientific Title:Acronym
Social support contributes to preventing postpartum depressive symptoms of Vietnamese women in Japan
Region
| Japan |
Condition
Condition
Postpartum depression
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clearly for experiences from pregnancy to child-rearing in Vietnamese women in Japan, and their perceived social support
Basic objectives2
Others
Basic objectives -Others
To clarify the contents of perceived social support in Vietnamese families in Japan. That will be used for future support.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Postpartum depressive symptoms
Key secondary outcomes
Social support, experiences of pregnancy, childbirth, and child-rearing
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Inclusion criteria for participants are as follows:
1. Vietnamese women residing in metropolitan areas of Japan who have a child under one year old at the time of the first interview.
2. Relationship status did not matter, including whether they had a partner or were living with one.
3. Willingness to be accompanied by a Vietnamese interpreter during interviews.
4. Provision of informed consent to participate in the study.
5. Consent to audio recording of both the participant and their child during the interview.
Key exclusion criteria
Exclusion criteria for participants are as follows:
1. Individuals who have children over one year of age at the time of the first interview.
2. Individuals without any experience of pregnancy, childbirth, or child-rearing in Japan.
3. Individuals who are unable to participate in an interview conducted in either Vietnamese or Japanese.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | SHIBAYAMA |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba 305-8575
TEL
029-853-3023
taiga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | SHIBAYAMA |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba 305-8575
TEL
029-853-3023
Homepage URL
taiga@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
The Institute of Seizon and Life Sciences
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba 305-8575
Tel
029-853-3023
sien.ningenss@un.tsukuba.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
| 2025 | Year | 09 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Each participant will be interviewed three times at appropriate intervals.
Based on an interview guide developed with reference to previous studies, data will be collected on the following themes during each session:
Interview 1: Experiences up to the pregnancy period
Interview 2: Childbirth experiences
Interview 3: Child-rearing experiences and perspectives on parenting
A Vietnamese interpreter will be present for all interviews.
Participants will be encouraged to choose either Japanese or Vietnamese, whichever language they feel more comfortable speaking.
This study will be conducted with cultural sensitivity, ensuring careful consideration of each participant's cultural background and maintaining a culturally respectful approach throughout the research process.
Management information
Registered date
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067461
