UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048654 |
|---|---|
| Receipt number | R000055442 |
| Scientific Title | Relationship between nocturnal sleep structure and crying/fussy behavior in early infancy and maternal mental health |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2025/02/19 16:06:47 |
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Basic information
Public title
Relationship between nocturnal sleep structure and crying/fussy behavior in early infancy and maternal mental health
Acronym
Relationship between nocturnal sleep structure and crying/fussy behavior in early infancy and maternal mental health
Scientific Title
Relationship between nocturnal sleep structure and crying/fussy behavior in early infancy and maternal mental health
Scientific Title:Acronym
Relationship between nocturnal sleep structure and crying/fussy behavior in early infancy and maternal mental health
Region
| Japan |
Condition
Condition
full-term infants and their mothers
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the sleep structure of nocturnal sleep and night crying behavior in 4-month-old infants, their development at 7-month-old, and materenal mental health of the third trimester pregnancy and postpartum period.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep structure and crying behavior in 4-month-old infants
1)A miniature actigraph (Micro-mini RC, Ambulatory Monitoring Inc., NY, USA)
2)A single-channel portable EEG device (Sleep Scope, SleepWell Co., Osaka, Japan)
3)A timetable for recording sleep and crying/fussy behavior in infants
Key secondary outcomes
Development at 7-month-old infants
1)Kinder Infant Development Scale
Mental health of mothers (late pregnancy and 4 and 7 months postpartum)
1)State-Trait Anxiety Inventory-Form JYZ
2)The Center for Epidemiologic Studies Depression Scale
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. Normal singleton infant born at term
2. Infants whose mothers gave consent for research cooperation
Key exclusion criteria
1. Infants requiring NICU hospitalization management
2. Mothers with medical diseases requiring hospitalization
3. Mothers who drink or smoke
4. Mothers with a history of mental illness and risk factors for depression, such as low economic status
Include cesarean deliveries, excluding emergency cesarean deliveries.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | MAYUKO |
| Middle name | |
| Last name | KUMAGAI |
Organization
Akita University
Division name
Graduate School of Health Sciences, Department of nursing
Zip code
010-8543
Address
1-1-1, Hondo, Akita-City, Akita, Japan
TEL
0188846521
mayukok@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | MAYUKO |
| Middle name | |
| Last name | KUMAGAI |
Organization
Akita University
Division name
Graduate School of Health Sciences, Department of nursing
Zip code
010-8543
Address
1-1-1, Hondo, Akita-City, Akita, Japan
TEL
0188846521
Homepage URL
mayukok@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
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
The General Affairs Division Research Cooperation Office at Akita University Graduate School of Medicine and Faculty of Medicine
Address
Hondo, Akita-City, Akita, Japan
Tel
0188846210
soken@hos.akita-u.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
| 2022 | Year | 08 | Month | 15 | 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
5
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
| 2022 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational research
Relational exploration research
Recruitment method:
During postpartum hospitalization at the research facility, the person in charge hands the mother a form indicating the outline of the research and the purpose of recruiting collaborators.
For those who are willing to listen to explanations about research cooperation, we will explain the purpose and method of the research at the one-month postnatal checkup, and conduct a survey for those who have given consent.
The survey period is scheduled to be from the date of permission to conduct research until August 2026.
Management information
Registered date
| 2022 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055442
