Young Children's Sleep Patterns and Problems Among Turkish Children

Sponsor
Marmara University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04926064
Collaborator
(none)
2,089
1
4
521.2

Study Details

Study Description

Brief Summary

Sleep is important for optimal child growth, development, and family functioning. Behavioral pediatric insomnia is one of the most prevalent sleep disorders identified in young children. Well-child visits represent an important setting for addressing concerns regarding the child's sleep patterns and sleep problems.

Investigators aimed to describe sleep/wake patterns of young children, evaluate the associations between parental depressive, and anxiety symptoms, parental involvement in child-care, sleep-related behaviors and children's sleep parameters.

The study has a descriptive cross-sectional study design. An estimated sample size was 2089 participants considering the number of children aged between 6-36 months in the country, and the estimated prevalence of Behavioral Insomnia being 30%. A multi-stage stratification is used to calculate the number of participants to be taken at the level of 12 geographical regions according to Nomenclature of Territorial Units for Statistics (NUTS-1). A sleep study group is established by the study coordinator, and researchers running a well-child outpatient clinic from each region across the country are included.

Investigators invite mothers of children aged 6 to 36 months who either visited for a well-child outpatient clinic or in the waiting list for follow up to complete the online questionnaire about their children's sleep/wake patterns utilizing mailing lists obtained from the outpatient clinics. Recruitment will take place from April to June 2021. The questionnaire included Brief Infant Sleep Questionnaire (BISQ), Edinburgh Postnatal Depression Scale (EPDS) and Generalized Anxiety Disorder (GAD-7) scale, and separate questions on fathers' involvement in child care, and sociodemographic characteristics. An online google survey is developed on the google platform securing data collection by a confidential log in system which can be filled out from smartphones, tablet or computer. The questionnaire takes approximately 20 minutes to complete.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Sleep is important for optimal child growth, development, and family functioning. Behavioral pediatric insomnia is one of the most prevalent sleep disorders identified in young children. Well-child visits represent an important setting for addressing concerns regarding the child's sleep patterns and sleep problems.

    Investigators aimed to describe sleep/wake patterns of young children, evaluate the associations between parental depressive, and anxiety symptoms, parental involvement in child-care, sleep-related behaviors and children's sleep parameters.

    The study has a descriptive cross-sectional study design. According to the formula for the known number of individuals in the universe [Sample formula with known number of individuals n = [Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)], (α=0.05, p=0.32, d=0.02) the sample size to represent the population was found to be 2089, considering the number of children aged between 6-36 months in the country, and the estimated prevalence of Behavioral Insomnia being 30%. A multi-stage stratification is used to calculate the number of participants to be taken at the level of 12 geographical regions according to Nomenclature of Territorial Units for Statistics (NUTS-1). A sleep study group is established by the study coordinator, and researchers running a well-child outpatient clinic from each region across the country are included.

    Investigators invite mothers of children aged 6 to 36 months who either visited for a well-child outpatient clinic or in the waiting list for follow up to complete the online questionnaire about their children's sleep/wake patterns utilizing mailing lists obtained from the outpatient clinics. Recruitment will take place from April to June 2021. The questionnaire included Brief Infant Sleep Questionnaire (BISQ), Edinburgh Postnatal Depression Scale (EPDS) and Generalized Anxiety Disorder (GAD-7) scale, and separate questions on fathers' involvement in child care, and sociodemographic characteristics. An online google survey is developed on the google platform securing data collection by a confidential log in system which can be filled out from smartphones, tablet or computer. The questionnaire takes approximately 20 minutes to complete.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2089 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Young Children's Sleep Patterns and Problems Among Turkish Children: Cross-sectional Study From a Nationally Representative Sample
    Actual Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2021
    Anticipated Study Completion Date :
    Aug 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Sleep wake patterns [Baseline]

      Sleep wake patterns of children aged between 6-36 months

    2. Sleep problem [Baseline]

      Maternal report of sleep problem

    Secondary Outcome Measures

    1. maternal depression [Baseline]

      maternal depression score assessed with Edinburgh Postnatal Depression Scale

    2. maternal anxiety [baseline]

      maternal anxiety score assessed with Generalized Anxiety Scale-7

    3. paternal involvement in child care [baseline]

      paternal involvement will be assessed with 5 questions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 36 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • mothers of healthy infants aged between 6 to 36 months
    Exclusion Criteria:

    infants <37 gestational week, congenital disease, neurodevelopmental disorder, use of drugs that can affect sleep such as diphenhydramine, Obstructive Sleep Apnea diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marmara University School of Medicine Istanbul Turkey

    Sponsors and Collaborators

    • Marmara University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Perran Boran, Professor of Pediatrics, Marmara University
    ClinicalTrials.gov Identifier:
    NCT04926064
    Other Study ID Numbers:
    • 09.2021.489
    First Posted:
    Jun 14, 2021
    Last Update Posted:
    Jun 16, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Perran Boran, Professor of Pediatrics, Marmara University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 16, 2021