UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049918 |
|---|---|
| Receipt number | R000056849 |
| Scientific Title | Development of a program to prevent postpartum depression and promote maternal roles: A randomized controlled study |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/27 14:04:31 |
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Basic information
Public title
The effectiveness of programs to prevent postpartum depression and promote the maternal role
Acronym
The effectiveness of programs to prevent postpartum depression and promote the maternal role
Scientific Title
Development of a program to prevent postpartum depression and promote maternal roles:
A randomized controlled study
Scientific Title:Acronym
Development of a program to prevent postpartum depression and promote maternal roles:A randomized controlled study
Region
| Japan |
Condition
Condition
Postpartum depression
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of a program that promotes the mental health of mothers and their maternal role
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Early Childhood Parenting Scale
K6
Key secondary outcomes
Mother's Child Care Stress Scale
A Japanese version of a 12 item Self Compassion scale Short Form
A Japanese version of The meaning of life scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will attend a 90-minute program once a week for six sessions.
Interventions/Control_2
The control group can take the same program after the intervention group completes the program
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
First-time mothers 3-6 months postpartum
Key exclusion criteria
K6 score of 5 or more
Cannot understand Japanese
History of psychiatric illness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Kimura |
Organization
Nagoya City University Graduate School
Division name
Graduate School of Nursing
Zip code
4678601
Address
1 Kawasumi, Aza Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
0528538051
kimura703hm@gmail.com
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Kimura |
Organization
Nagoya City University Graduate School
Division name
Graduate School of Nursing
Zip code
467-8601
Address
1 Kawasumi, Aza Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8051
Homepage URL
nao1710@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Naomi Kimura
Funding Source
Organization
Nagoya City University
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
Nagoya City University Graduate School Graduate School of Nursing Research Ethics Committee
Address
1 Kawasumi, Aza Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-851-5511
nao1710@med.nagoya-cu.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 | 12 | Month | 28 | 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
32
Results
The program had the effect of promoting the maternal role and maintaining mental health
Results date posted
| 2022 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the mothers was 32.56 years. All study participants were married
Participant flow
There were 32 study participants (intervention group = 16, control group = 16).
Adverse events
Nothing
Outcome measures
Early Childhood Parenting Scale
K6
Mother's Child Care Stress Scale
A Japanese version of a 12-item Self-Compassion scale-Short Form
A Japanese version of The meaning of life scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056849
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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