- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07476612
Sleep Patterns in Children Aged 0-36 Months and Maternal Anxiety and Depression
Maternal Anxiety and Depression and Their Association With Sleep Patterns in Children Aged 0-36 Months
Study Overview
Status
Conditions
Detailed Description
Sleep problems during infancy and early childhood are common and may affect both child development and family well-being. Maternal psychological status, particularly anxiety and depression, may play an important role in shaping infant sleep patterns through behavioral and environmental mechanisms. Understanding this relationship may help identify families at risk and contribute to early supportive interventions.
This observational study aims to investigate the relationship between sleep patterns of children aged 0-36 months and maternal anxiety and depression levels. Infant sleep characteristics, including total sleep duration, number of night awakenings, and sleep quality, will be assessed using the Brief Infant Sleep Questionnaire-Revised (BISQ-R) completed by mothers.
Maternal psychological status will be evaluated using validated psychological assessment tools. Maternal depression will be assessed using the Beck Depression Inventory (BDI), while maternal anxiety levels will be assessed using the Beck Anxiety Inventory (BAI).
The association between infant sleep parameters and maternal anxiety and depression scores will be analyzed to evaluate the potential relationship between maternal psychological status and infant sleep patterns in children aged 0-36 months. The findings of this study are expected to improve understanding of factors influencing sleep during early childhood and may help inform early supportive strategies for families.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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İ̇stanbul
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Başakşehir, İ̇stanbul, Turkey (Türkiye), 34107
- Basaksehir Cam ve Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers
Exclusion Criteria:
- Outpatients,
- Newborns aged 0-29 days,
- Patients over 3 years of age,
- Infants diagnosed with chronic diseases,
- Infants diagnosed sleep disorders,
- Mothers diagnosed with psychiatric disorders,
- Mothers receiving regular medical treatment for anxiety and depression disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hospitalized infants (0-36 months) and mothers
Single cohort of mother-infant dyads with infants aged 0-36 months hospitalized in the pediatric inpatient ward.
Maternal anxiety and depressive symptoms were assessed using the Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI).
Infant sleep characteristics were assessed using the Brief Infant Sleep Questionnaire (BISQ).
No intervention was administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Spearman Correlation Between Maternal Anxiety and Infant Sleep Status
Time Frame: single assessment at enrollment during inpatient hospitalization
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Spearman correlation (rho) between maternal Beck Anxiety Inventory (BAI) total score (0-63 points) and infant total sleep duration (hours) assessed by the Brief Infant Sleep Questionnaire (BISQ) at enrollment during inpatient hospitalization.
Unit of measure: Spearman rho (correlation coefficient).
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single assessment at enrollment during inpatient hospitalization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between Maternal Depression and Infant Sleep Status
Time Frame: single assessment at enrollment during inpatient hospitalization
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pearman correlation (rho) between maternal Beck Depression Inventory (BDI) total score (0-63 points) and infant total sleep duration (hours) assessed by BISQ at enrollment during inpatient hospitalization.
Unit of measure: Spearman rho.
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single assessment at enrollment during inpatient hospitalization
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Maternal Anxiety Score by Infant Sleep Disorder Status
Time Frame: Baseline (single assessment at enrollment during inpatient hospitalization)
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Comparison of maternal BAI total score (0-63 points) between infants with vs without BISQ-defined sleep disorder (>3 night awakenings OR >60 min nocturnal wakefulness OR <9 h total sleep duration) at enrollment during inpatient hospitalization.
Unit of measure: BAI total scores.
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Baseline (single assessment at enrollment during inpatient hospitalization)
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Sleep Disorder Proportion by Maternal Sleep Satisfaction
Time Frame: Baseline (single assessment at enrollment during inpatient hospitalization)
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Proportion of infants with BISQ-defined sleep disorder compared across maternal sleep satisfaction categories (very satisfied, moderately satisfied, not satisfied) assessed at enrollment during inpatient hospitalization.
Unit of measure: % (proportion).
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Baseline (single assessment at enrollment during inpatient hospitalization)
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Collaborators and Investigators
Investigators
- Principal Investigator: Furkan ÇOLAK, Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey
- Principal Investigator: Şeymanur UÇUM, MD, Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCSSH-SBU-ŞU-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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