UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055009 |
|---|---|
| Receipt number | R000062799 |
| Scientific Title | Effectiveness of a parent education program for establishing infant sleep habits |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/01/17 10:01:04 |
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Basic information
Public title
A study on an education program for babies' sleep
Acronym
A study on an education program for babies' sleep
Scientific Title
Effectiveness of a parent education program for establishing infant sleep habits
Scientific Title:Acronym
Effectiveness of a parent education program for establishing infant sleep habits
Region
| Japan |
Condition
Condition
Healthy pregnant women and infants
Classification by specialty
| Nursing | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a parent education program for establishing infant sleep habits on infant sleep, postpartum maternal sleep and depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Infant sleep at 6 weeks, 12 weeks, 18 weeks, 6 months, and 1 year old (questionnaire, sleep diary)
2. Maternal sleep at 6 weeks, 12 weeks, 18 weeks, 6 months, and 1 year postpartum (PSQI-J)
3. Maternal depression at 6 weeks, 12 weeks, 18 weeks postpartum (EPDS)
Key secondary outcomes
1. Maternal self-efficacy at 6 weeks, 12 weeks, 18 weeks postpartum (PSOC)
2. Behaviors that promote sleep in pregnant mothers (questionnaire)
3. Behaviors that promote sleep in mothers at 6 weeks, 12 weeks, 18 weeks, 6 months, and 1 year postpartum (questionnaire)
4. Behaviors that promote sleep in infants at 6 weeks, 12 weeks, 18 weeks, 6 months, and 1 year old (questionnaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
An online parent education program on maternal and infant sleep (one 50-minute individual education session in late pregnancy, monthly email updates on learning content, one 15-minute individual consultation at 5 weeks after birth, and one 15-minute individual consultation upon request at 11 weeks after birth)
Interventions/Control_2
Usual care
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 singleton primiparous babies of gestational age 28-41 weeks
Key exclusion criteria
1. Taking sleeping pills during pregnancy or after childbirth
2. Working in a job that involves night shifts during pregnancy or after childbirth
3. After childbirth, the mother or infant is transferred to a general hospital or university hospital other than the planned delivery facility due to their health issues
4. The infant is admitted to a neonatal intensive care unit
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Matsunaka |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-0054
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka City, Fukuoka
TEL
092-642-6680
eriko.397@s.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Matsunaka |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-0054
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka City, Fukuoka
TEL
092-642-6680
Homepage URL
eriko.397@s.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Eriko Matsunaka
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Kyushu International College of Nursing
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Kyushu International College of Nursing
Address
1-1, Asty, Munakata city, Fukuoka
Tel
0940-35-7001
keiri@jrckicn.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
| 2024 | Year | 08 | Month | 01 | 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
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2024 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062799
