UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024213 |
|---|---|
| Receipt number | R000027883 |
| Scientific Title | A study on the development of a support program for mothers of crying infants |
| Date of disclosure of the study information | 2016/09/28 |
| Last modified on | 2023/10/05 19:59:04 |
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Basic information
Public title
A study on the development of a support program for mothers of crying infants
Acronym
A study of intervention with mothers feeling distressed when their infants cry
Scientific Title
A study on the development of a support program for mothers of crying infants
Scientific Title:Acronym
A study of intervention with mothers feeling distressed when their infants cry
Region
| Japan |
Condition
Condition
Postpartum mothers
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of intervention in reducing mothers' feeling of anxiety and stress regarding their babies' crying.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mothers' felling of distress levels
Time of evaluation; after birth, one months, 7~8months
Key secondary outcomes
Mothers' emotional responses levels to crying infants
Mothers' anxiety levels
Sense of Coherence levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group;Distribution of educational material regarding phases of being able to interpret babies' crying with pregnancy, after birth, after birth one month.
Interventions/Control_2
Control group; No intervention
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
Female
Key inclusion criteria
1) Normal pregnant women(more 20 weeks gestation)
2) Premipara
3) Pregnant womens who have signed to an approved informed consent.
Key exclusion criteria
1) Multipara
2) Pregnant women fetal abnormalities are suspected
3) Twins, triplets and multiple birth
4) Preterm delibery (Pregnancy of the less than 37weeks)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Tabuchi |
Organization
Kanazawa University
Division name
Division of Health Sciences, College of Medical, Pharmaceutical and Health Science
Zip code
920-0942
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa, Japan
TEL
076-265-2557
tabuchi@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Tabuchi |
Organization
Kanazawa University
Division name
Division of Health Sciences, College of Medical, Pharmaceutical and Health Science
Zip code
920-0942
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa, Japan
TEL
076-265-2557
Homepage URL
tabuchi@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Division of Health Sciences, College of Medical, Pharmaceutical and Health Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, Culuture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
5-11-80 Kodatsuno, Kanazawa, Ishikawa, Japan
Tel
076-265-2557
tabuchi@staff.kanazawa-u.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
| 2016 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
none
Publication of results
Partially published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
67
Results
In summary, intervention was not shown to be effective in reducing the score for distress when a mother's baby cried, either one month after or eight months after birth.
Results date posted
| 2023 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pregnant women with a normal course who come for antenatal checkups at two obstetric facilities where research consent has been obtained
Participant flow
Pregnant women who receive antenatal care at one of the two maternity facilities will serve as the control group and will receive usual antenatal care and postpartum care. Pregnant women at the other maternity facility will be the intervention group who will receive information on crying during pregnancy and at one month postpartum. Both groups will receive questionnaires during pregnancy and at 1 and 8 months postpartum.
Adverse events
none
Outcome measures
the score for distress when a mother's baby cried
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
The 37th Annual Conference of Japan Academy of Nursing Science in Sendai 2017
Japan Academy of Midwifery in YOKOHAMA 2018
Japan Academy of Midwifery in FUKUOKA 2019
Management information
Registered date
| 2016 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027883
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