NCT07476612

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 9, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

Early childhoodSleep problemsMaternal anxietyDepressionMaternal mental health

Outcome Measures

Primary Outcomes (1)

  • Spearman Correlation Between Maternal Anxiety and Infant Sleep Status

    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).

    single assessment at enrollment during inpatient hospitalization

Secondary Outcomes (3)

  • Correlation Between Maternal Depression and Infant Sleep Status

    single assessment at enrollment during inpatient hospitalization

  • Maternal Anxiety Score by Infant Sleep Disorder Status

    Baseline (single assessment at enrollment during inpatient hospitalization)

  • Sleep Disorder Proportion by Maternal Sleep Satisfaction

    Baseline (single assessment at enrollment during inpatient hospitalization)

Study Arms (1)

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.

Eligibility Criteria

Age1 Month - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study includes children aged 0-36 months and their mothers. Children's sleep patterns were assessed using the Brief Infant Sleep Questionnaire (BISQ). Mothers' anxiety and depression levels were assessed using validated questionnaires (The Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI)). Participants were recruited from pediatric inpatient clinics.

You may qualify if:

  • Children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Başakşehir, İ̇stanbul, 34107, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ParasomniasDepression

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Furkan ÇOLAK

    Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey

    PRINCIPAL INVESTIGATOR
  • Şeymanur UÇUM, MD

    Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 17, 2026

Study Start

October 22, 2025

Primary Completion

January 15, 2026

Study Completion

February 27, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations