UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016579 |
|---|---|
| Receipt number | 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 | 2024/08/26 10:14:38 |
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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
| Obstetrics 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
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
matsumoto@c.kyoai.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Department of Plastic and Reconstructive Surgery
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019235
