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NCT Number: NCT07476612

Sleep Patterns in Children Aged 0-36 Months and Maternal Anxiety and Depression

In this study, the investigators aimed to investigate the relationship between the sleep patterns of children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers' anxiety and depression levels.

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Key information

Conditions

Sleep Problems Behavior Behavioral Symptoms Depression Maternal Anxiety Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

1 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Basaksehir Cam ve Sakura City Hospital

Başakşehir, İ̇stanbul, 34107, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Spearman Correlation Between Maternal Anxiety and Infant Sleep Status

    Time frame: single assessment at enrollment during inpatient hospitalization

    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).

Secondary outcomes

  1. Correlation Between Maternal Depression and Infant Sleep Status

    Time frame: single assessment at enrollment during inpatient hospitalization

    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.

  2. Maternal Anxiety Score by Infant Sleep Disorder Status

    Time frame: Baseline (single assessment at enrollment during inpatient hospitalization)

    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.

  3. Sleep Disorder Proportion by Maternal Sleep Satisfaction

    Time frame: Baseline (single assessment at enrollment during inpatient hospitalization)

    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).

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Maternal Anxiety and Depression and Their Association With Sleep Patterns in Children Aged 0-36 Months

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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