UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044812 |
|---|---|
| Receipt number | R000051178 |
| Scientific Title | Test for confirming the efficacy of an intervention program using videos for enhancing mother-infant bonding |
| Date of disclosure of the study information | 2021/07/09 |
| Last modified on | 2022/07/10 12:14:36 |
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Basic information
Public title
Test for confirming the efficacy of an intervention program using videos for enhancing mother-infant bonding
Acronym
Test for confirming the efficacy of an intervention program using videos for enhancing mother-infant bonding
Scientific Title
Test for confirming the efficacy of an intervention program using videos for enhancing mother-infant bonding
Scientific Title:Acronym
Test for confirming the efficacy of an intervention program using videos for enhancing mother-infant bonding
Region
| Japan |
Condition
Condition
Mother-to-infant Bonding Disorder
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce mothers' misreading of their infants' signals, a preventive intervention of mother-to-infant bonding disorder was started by asking pregnant mothers to watch videos. The study aims to confirm the efficacy of the intervention by evaluating their psychological scales assessing the postpartum mother-infant bonding and postpartum depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
X: MIBS-J scores and EPDS scores one month after childbirth; and the differences from the scores three and six months after childbirth in the intervention group.
Y: MIBS-J scores and EPDS scores one month after childbirth; and the differences from the scores three and six months after childbirth in the control group.
Differences between X and Y.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The control group mothers are asked to fill in the questionnaires distributed during pregnancy and one, three and six months after childbirth.
Interventions/Control_2
The intervention group mothers are asked to watch infant-related videos during pregnancy and one month after childbirth. At the same time, they are asked to fill in the questionnaires distributed during pregnancy and one, three and six months after childbirth.
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
Women 28 or more weeks pregnant, regardless of primiparas or multiparas.
The women participating in the study are required to fully understand the adequately provided explanation concerning the study, and express the consent on their own free will.
Key exclusion criteria
Those who cannot read and write in Japanese.
Target sample size
640
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Fujita |
Organization
Mejiro University
Division name
Department of Nursing
Zip code
3398501
Address
320 Ukiya,Iwatsuki-ku Saitama-shi Saitama,Japan
TEL
0487972131
ka.fujita@mejiro.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | fujita |
Organization
Mejiro University
Division name
Department of Nursing
Zip code
3398501
Address
320 Ukiya,Iwatsuki-ku Saitama-shi Saitama,Japan
TEL
0487972131
Homepage URL
ka.fujita@mejiro.ac.jp
Sponsor or person
Institute
Mejiro University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mejiro University Medical Research ethics committe
Address
320 Ukiya,Iwatsuki-ku Saitama-shi Saitama,Japan
Tel
0487972131
univsyomu@mejiro.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
目白大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 09 | 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
| 2021 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051178
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
