UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063065 |
|---|---|
| Receipt number | R000072185 |
| Scientific Title | Needs for sleep support and nursing practices for infants aged 1-2 months and their caregivers: A multicenter cross-sectional survey of mothers, partners, and nursing professionals |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/27 07:27:48 |
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Basic information
Public title
A survey of sleep support needs among infants aged 1-2 months and their families and nursing support
Acronym
Baby Sleep Study
Scientific Title
Needs for sleep support and nursing practices for infants aged 1-2 months and their caregivers: A multicenter cross-sectional survey of mothers, partners, and nursing professionals
Scientific Title:Acronym
Infant Sleep Support Gap Study (ISSGS)
Region
| Japan |
Condition
Condition
Healthy postpartum women, partners, and nursing professionals
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the implementation of sleep support for infants and caregivers and the perceived importance of such support from the perspectives of caregivers and nursing professionals.
To identify priority areas for sleep support using Borich's needs assessment and the Locus for Focus model.
Basic objectives2
Others
Basic objectives -Others
To examine differences by participant characteristics in infant and caregiver sleep, caregivers' sleep support needs, and the implementation and perceived importance of sleep support.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Implementation and perceived importance of sleep support for infants and caregivers
Key secondary outcomes
1. Caregiver outcomes: Infant sleep, caregiver sleep, social support, concerns regarding infant sleep and the timing of these concerns, concerns regarding caregiver sleep and the timing of these concerns, timing when sleep support is needed for infants and caregivers, sources of information and consultation regarding infant and caregiver sleep, information and support needed regarding infant and caregiver sleep
2. Nursing professional outcomes: Timing of sleep support provision for infants and caregivers, strategies and approaches used to provide sleep support for infants and caregivers, difficulties in providing sleep support for infants and caregivers, frequency of sleep support provided to partners regarding infant and caregiver sleep, types of sleep support provided to partners regarding infant and caregiver sleep, requests and expectations regarding sleep support for infants and caregivers
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Mothers
Mothers who gave birth at a participating institution and are caring for an infant aged 1-2 months. Mothers are eligible regardless of whether their infant has a history of admission to a neonatal care unit and regardless of whether they have a partner. Participants must be able to complete the web-based questionnaire in Japanese.
(2) Partners
The spouse or an individual who lives with the mother described above and is involved in childcare. Participants must be able to complete the web-based questionnaire in Japanese.
(3) Nursing professionals
Nursing professionals working at participating medical institutions who are involved in providing support to infants aged 1-2 months and their families from pregnancy through the infant's first 1-2 months of life. Participants must be able to complete the web-based questionnaire in Japanese.
Midwives and nurses working in obstetric outpatient departments
Midwives and nurses working in obstetric wards
Nurses and midwives working in neonatal care units
Midwives and nurses working in pediatric outpatient departments, including those involved in one-month infant health checkups and follow-up care after discharge from neonatal care units
Key exclusion criteria
Individuals who are not living with the infant at the time of the survey.
Target sample size
290
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Matsunaka |
Organization
Japanese Red Cross Kyushu International College of Nursing
Division name
Faculty of Nursing
Zip code
811-4157
Address
1-1 Asty, Munakata-shi, Fukuoka, Japan
TEL
0940-35-7001
e-matsunaka@jrckicn.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Matsunaka |
Organization
Japanese Red Cross Kyushu International College of Nursing
Division name
Faculty of Nursing
Zip code
811-4157
Address
1-1 Asty, Munakata-shi, Fukuoka, Japan
TEL
0940-35-7001
Homepage URL
e-matsunaka@jrckicn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Kyushu International College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Kyushu International College of Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2026 | Year | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter cross-sectional survey of infants aged 1-2 months and their caregivers (mothers and partners), as well as nursing professionals. A web-based questionnaire will be used to assess infant and caregiver sleep status, concerns regarding sleep, support needs, sources of information and consultation, and the implementation and perceived importance of sleep support. Nursing professionals will also be surveyed regarding the timing and content of sleep support, strategies used, difficulties in providing support, support provided to partners, and requests regarding sleep support. The data will be used to compare sleep support needs and practices between caregivers and nursing professionals and to identify issues and priority areas for sleep support.
Management information
Registered date
| 2026 | Year | 09 | Month | 27 | Day |
Last modified on
| 2026 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072185
