UMIN-CTR Clinical Trial

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
Email	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
Email	ka.fujita@mejiro.ac.jp

Sponsor
Institute	Mejiro University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051178