UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055419 |
|---|---|
| Receipt number | R000063331 |
| Scientific Title | Mental Health Literacy of Nursing Staff and Support for Mother-to-Infant Bonding During the 2 Weeks Postpartum |
| Date of disclosure of the study information | 2024/09/04 |
| Last modified on | 2024/12/26 10:39:55 |
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Basic information
Public title
Mental Health Literacy of Nursing Staff and Support for Mother-to-Infant Bonding During the 2 Weeks Postpartum
Acronym
Mental Health Literacy of Nursing Staff and Support for Mother-to-Infant Bonding
Scientific Title
Mental Health Literacy of Nursing Staff and Support for Mother-to-Infant Bonding During the 2 Weeks Postpartum
Scientific Title:Acronym
Mental Health Literacy of Nursing Staff and Support for Mother-to-Infant Bonding
Region
| Japan |
Condition
Condition
bonding disorder
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current state of mental health literacy of nursing staff and the state of support for Mother-to-Infant Bonding durring the 2 weeks postoartum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Support for mother-to-infant bonding during 2 weeks postpartum
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Obstetric facilities that handle childbirth and conduct two-week postpartum checkups
2) Nursing staff who care for postpartum women during hospitalization for childbirth or provide health guidance at two-week postpartum checkups
3) Able to answer questions in Japanese
4) Own a smartphone or other electronic device that can answer the questionnaire
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Okayama |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-8372
okayama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Tanaka |
Organization
University of Tsukuba
Division name
master's program in nursing science
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3251
Homepage URL
s2321381@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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, Ibaraki, Japan
Tel
029-853-3251
s2321381@u.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
| 2024 | Year | 09 | Month | 04 | 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
| 2024 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 13 | 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
To clarify the current state of mental health literacy of nursing staff and the state of support for mother-to-infant bonding during 2 weeks postpartum
Management information
Registered date
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063331
