Young Children's Sleep Patterns and Problems Among Turkish Children

NCT04926064 | Completed

• 1 other identifier: 09.2021.489
• Study Type: observational
• Target: 2,434
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior Problem

Keywords

sleep; insomnia; children

Outcome Measures

Primary Outcomes (2)

• Sleep wake patterns

  Sleep wake patterns of children aged between 6-36 months

  Baseline

• Sleep problem

  Maternal report of sleep problem

  Baseline

Secondary Outcomes (3)

• maternal depression

  Baseline

• maternal anxiety

  baseline

• paternal involvement in child care

  baseline

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

mothers of healthy infants aged between 6 to 36 months

You may qualify if:

• mothers of healthy infants aged between 6 to 36 months

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: April 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: August 14, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

TU (1)