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临床试验/NCT05191576
NCT05191576Unknown不适用

Sleep Problems in Epileptic Children and Their Caregivers: Associations With Psychometric

Ege University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Sleep disturbances correlation with behavioral difficulties in epileptic children

研究概览

简要总结

The aim of this study is to investigate the frequency of sleep problems in epileptic children and their caregivers.

详细描述

The study instruments include two parts. First, data on socio-demographic, height, weight, the sleep duration, caregiver's level of education (Illiterate, Preliminary school, High school, University), caregiver sleep problems, and medical background were noted. Clinical data regarding epilepsy (a type of seizure, etiology, the frequency of seizures, actual and previous antiseizure medications) were collected from interviews of participants/parents and examination. Second, the psychometric assessment tools used to evaluate all participants and caregivers; Children's sleep habits questionnaire (CSHQ), strength and difficulties questionnaire (SDQ), diagnostic and statistical manual of mental disorders (DSM)-V Sleep Disorders Scale-Child Report, DSM-V Sleep Disorder Scale- Adult Report. All participants and their caregivers completed the psychometric questionnaires.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of epilepsy that based on the International League Against Epilepsy (ILAE) operational clinical definition criteria for epilepsy
  • must be diagnosed by pediatric neurologists
  • must receive treatment for at least one year.

排除标准

  • to have an IQ ≤80, as measured by the Wechsler Intelligence Scale for Children-Revised Form (WISC-R) or below-average academic performance documented by last year's final school grade
  • to have a history of psychiatric, developmental disorder, or psychosis
  • to have a history of progressive neurological disorder other than epilepsy
  • to have any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep
  • to have a caregiver who has any medical or psychiatric condition (e.g., depression or anxiety) that could interfere with sleep.

结局指标

主要结局

Sleep disturbances correlation with behavioral difficulties in epileptic children

时间窗: participant would be assessed at the beginning of the study

The subscales of sleep problems would be investigated with Diagnostic and Statistical Manual of Mental Disorders (DSM) -V Level II Sleep Disturbance- Child Report,Children's Sleep Habits Questionnaire. The subscales of behavioral problems in epileptic children would be investigated with Strength and Difficulties Questionnaire.The correlation of these subscales would be correlated with statistical methods to define significant differences.

次要结局

未报告次要终点

研究者

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

İpek Dokurel

Principal Investigator

Ege University

研究点 (1)

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