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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024213
Receipt No. 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 2019/04/09

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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
Obsterics 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
Email 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
Email tabuchi@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Division of Health Sciences, College of Medical, Pharmaceutical and Health Science
Institute
Department

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
Email 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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Questionnaires were sent twice to two different hospitals to recruit pregnant women for this study. 28 women responded from one hospital agreeing to participate in this study and became the intervention group. 39 women responded from the other hospital and became the non-intervention group (total effective response rate of 83.8%). Analysis of the results showed the age to be 32.2 +- 6.2 (Ave. +- SD) for the intervention group and 29.1 +- 6.2 for the non-intervention group. The average age for the intervention group was significantly higher than the non-intervention group (p < 0.05), however, there was no significant difference in the two groups for STAI score, SOC score or distress score for when baby cried (27.4 +- 5.0 for intervention group and 27.4 +- 3.9 for non-intervention group) during pregnancy and one month after birth.
Follow-up questionnaires were distributed eight months after birth and responses were received from 22 mothers in the intervention group and 28 mothers in the non-intervention group (total effective response rate of 62.5%). Analysis of the results showed no significant difference in the distress score for the intervention group (25.4 +- 4.3) and non-intervention group (24.6 +- 4.0).
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
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 No longer recruiting
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
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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