跳至主要内容
临床试验/NCT04926064
NCT04926064已完成不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 2,434 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,434
试验地点
1
主要终点
Sleep wake patterns

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • mothers of healthy infants aged between 6 to 36 months

排除标准

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

结局指标

主要结局

Sleep wake patterns

时间窗: Baseline

Sleep wake patterns of children aged between 6-36 months

Sleep problem

时间窗: Baseline

Maternal report of sleep problem

次要结局

  • maternal anxiety(baseline)
  • maternal depression(Baseline)
  • paternal involvement in child care(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Perran Boran

Professor of Pediatrics

Marmara University

研究点 (1)

Loading locations...

相似试验