UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056434 |
|---|---|
| Receipt number | R000064489 |
| Scientific Title | Examining the Effectiveness of Role Lettering for Mothers Raising Their First Child at Age 0 |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2024/12/12 14:42:06 |
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Basic information
Public title
Examining the Effectiveness of Role Lettering for Mothers Raising Their First Child at Age 0
Acronym
Examining the Effectiveness of Role Lettering for Mothers Raising Their First Child at Age 0
Scientific Title
Examining the Effectiveness of Role Lettering for Mothers Raising Their First Child at Age 0
Scientific Title:Acronym
Effects of role lettering on mothers raising their first child at age 0
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of the intervention on the psychological aspects of mothers' child-rearing anxiety, self-esteem, and attachment to their children by conducting role-lettering with mothers raising their first child aged 0 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Once before the role lettering is implemented, and three times after the role lettering is implemented approximately every two weeks, for a total of four times. The following three questionnaires will be used to evaluate the effectiveness of the role lettering.
Mother to Infant Bonding Scale,Scale of Anxiety over Child-rearing, State Self-Esteem Scale
Key secondary outcomes
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Implementation of role lettering
Interventions/Control_2
Role lettering not implemented
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Mother raising her first child, a 0-year-old
Key exclusion criteria
Mothers with health disabilities and mothers raising children with health disabilities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kinuyo |
| Middle name | |
| Last name | Sakaeda |
Organization
Yamaguchi Prefectural University
Division name
Faculty of Nursing and Human Nutrition
Zip code
753-0021
Address
6-2-1,sakurabatake,yamaguti
TEL
083-933-1453
ksakaeda@yp4.yamaguchi-pu.ac.jp
Public contact
Name of contact person
| 1st name | Kinuyo |
| Middle name | |
| Last name | Sakaeda |
Organization
Yamaguchi Prefectural University
Division name
Faculty of Nursing and Human Nutrition
Zip code
753-0021
Address
6-2-1,Sakurabatake,Yamaguchi city,Japan
TEL
083-933-1453
Homepage URL
ksakaeda@yp4.yamaguchi-pu.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
Yamaguchi Prefectural University
Address
6-2-1,Sakurabatake,Yamaguchi city,Japan
Tel
083-933-1453
ksakaeda@yp4.yamaguchi-pu.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 | 12 | Month | 12 | 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
26
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
| 2023 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064489
