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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016579
Receipt No. R000019235
Scientific Title Psychological Effect of antenatal diagnosis and notice on mothers and mother-infant relationships and Psychological support
Date of disclosure of the study information 2015/02/24
Last modified on 2019/08/26

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Basic information
Public title Psychological Effect of antenatal diagnosis and notice on mothers and mother-infant relationships and Psychological support
Acronym Psychological Effect of antenatal diagnosis and notice on mothers and mother-infant relationships and Psychological support
Scientific Title Psychological Effect of antenatal diagnosis and notice on mothers and mother-infant relationships and Psychological support
Scientific Title:Acronym Psychological Effect of antenatal diagnosis and notice on mothers and mother-infant relationships and Psychological support
Region
Japan

Condition
Condition cleft lip and/or palate
Classification by specialty
Obsterics and gynecology Plastic surgery Dental medicine
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The Aim of this research is to understand how do Neonatal diagnosis and notice about cleft lip and/or palate psychologically influence on mothers and mother-infant relationship, and what kinds of support will be needed for mothers deep understanding of cleft and motivating infant parenting.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)scale about attachment style of mothers, depressive tendency, parenting stress, infant temperament
2)observation about mother-infant interaction for 10-15minites (evaluation will be used by emotional availability scale)

Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
19 months-old >
Gender Male and Female
Key inclusion criteria This research will be conducted with informed consent of mother whose infant is/will be a patient of Cleft lip and /or palate centre of Tohoku university hospital.
Key exclusion criteria If a infant has Other disease, they will be excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshimichi
Middle name
Last name Imai
Organization Tohoku University Graduate School of Medicine,
Division name Department of Plastic and Reconstructive Surgery
Zip code 9808574
Address 1-1 Seiryo, Aoba, Sendai
TEL 022-717-7748
Email yo-imai@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Matsumoto
Organization Kyoai Gakuen University
Division name Faculty of International Social Studies
Zip code 3792192
Address 1154-4 Koyabaha, Maebashi, Gunma
TEL 027-266-7575
Homepage URL
Email matsumoto@c.kyoai.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine, Department of Plastic and Reconstructive Surgery
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Kyoai Gakuen University
Address 1154-4 Koyahara, Maebashi, Gunma
Tel 0272667575
Email matsumoto@c.kyoai.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
2015 Year 02 Month 24 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 Open public recruiting
Date of protocol fixation
2014 Year 03 Month 24 Day
Date of IRB
2014 Year 03 Month 25 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective research will be conducted for mother and infant with cleft lip and/or palate after neonatal diagnosis and notice. The duration of the research will be the time from the time of the notice(before birth) to the time a infant will be the age of 18 month-old.

Management information
Registered date
2015 Year 02 Month 19 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019235

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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