UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016325 |
|---|---|
| Receipt number | R000018945 |
| Scientific Title | Longitudinal research on a parenting support program - HUG Your Baby - for parent-infant bonding |
| Date of disclosure of the study information | 2015/01/24 |
| Last modified on | 2022/01/06 13:58:48 |
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Basic information
Public title
Longitudinal research on a parenting support program - HUG Your Baby - for parent-infant bonding
Acronym
HUG Your Baby longitudinal research
Scientific Title
Longitudinal research on a parenting support program - HUG Your Baby - for parent-infant bonding
Scientific Title:Acronym
HUG Your Baby longitudinal research
Region
| Japan |
Condition
Condition
parenting
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to longitudinally evaluate women who received the HUG Your Baby program during antenatal period may have differences in attachment with the infant and parenting confidence compared to women who did not receive the program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Maternal confidence, Parenting confidence, Attachment
Key secondary outcomes
Parenting knowledge, Use of HUG Your Baby, Demographics, Postpartum depression, Difficulty in dealing with a crying infant, Abusive intention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
HUG Your Baby Program
- Three Zones
- SOSs (Signs of Overstimulation)
- What to do when a baby cries (What TO DO)
- Two types of sleeping (Active/Light sleep, Still/Deep sleep)
- Tips for successful breastfeeding
Interventions/Control_2
How to swaddle a baby
- How to swaddle correctly
- Balancing body temperature (materials of swaddle, what to wear under swaddle)
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
Pregnant women with more than 30 weeks gestational age
Key exclusion criteria
Severe complications
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Shimpuku |
Organization
St. Luke's International University
Division name
Women't Health and Midwifery
Zip code
Address
10-1 Akashicho Chuoku Tokyo
TEL
03-5550-2372
yoko-shimpuku@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Shimpuku |
Organization
St. Luke's International University
Division name
Women't Health and Midwifery
Zip code
Address
10-1 Akashicho Chuoku Tokyo
TEL
03-5550-2372
Homepage URL
yoko-shimpuku@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
St. Luke's Life Science Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | 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 | 12 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018945
