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Completed

NCT Number: NCT04926064

Young Children's Sleep Patterns and Problems Among Turkish Children

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.

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Key information

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Sleep wake patterns

    Time frame: Baseline

    Sleep wake patterns of children aged between 6-36 months

  2. Sleep problem

    Time frame: Baseline

    Maternal report of sleep problem

Secondary outcomes

  1. maternal depression

    Time frame: Baseline

    maternal depression score assessed with Edinburgh Postnatal Depression Scale

  2. maternal anxiety

    Time frame: baseline

    maternal anxiety score assessed with Generalized Anxiety Scale-7

  3. paternal involvement in child care

    Time frame: baseline

    paternal involvement will be assessed with 5 questions

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Young Children's Sleep Patterns and Problems Among Turkish Children: Cross-sectional Study From a Nationally Representative Sample

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2021
Registry last updated
Aug 26, 2022

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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