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临床试验/NCT04370210
NCT04370210已完成不适用

Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry

Hôpital NOVO1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2020年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
247
试验地点
1
主要终点
Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up

研究概览

简要总结

The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.

详细描述

The coronavirus epidemic reached France in January 2020 and the WHO declared the COVID-19 outbreak was a pandemic on 11 March 2020. In response to this pandemic the French government announced national containment starting on 17 March 2020. Some recent studies suggest that a containment duration of more than 10 days and an extension beyond the originally announced duration would increase the psychological impact of it.

Sleep is a vital function that contributes to the proper neurophysiological and psychological development of human beings especially children. Sleep disorders can have a major impact on a child's behavior, mood, cognitive performance and metabolism. Sleep disorders are often associated with depression, anxiety and cognitive changes. Chronic sleep disorders are also risk factors for mental illness To our knowledge, no study targeting the quality of sleep in children who usually receive psychiatric care is underway or has been published. It is essential to ask what the quality of sleep in children with a psychiatric diagnosis who suddenly lose their bearings and their usual daily routine (school, therapeutic groups, day hospitals, etc.) after several weeks of containment.

This study is designed to assess different parameters in the 2 groups of children (healthy volunteers and Child with follow-up in child psychiatry) :

  • the sleep quality,
  • the depression level,
  • the anxiety level,
  • if socio-demographic factors have an influence on sleep disorders,
  • if there is a correlation between children's sleep quality, and anxiety level / sleep quality in their parents.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged 7 to 11 years and 11 months included on the first day of containment in France on 17 March 2020
  • Child receiving care at the CMP of Cergy-le-Haut (medico-psychological center) on the 2020 active patient population (at least one appointment with a child psychiatrist, a psychologist, a psychomotor therapist or a speech therapist or in a therapeutic group between January and March 2020)
  • Child not receiving any psychiatric care and having no siblings (half-brother, half-sister) followed in child psychiatry
  • No parental opposition

排除标准

  • Poor French reading comprehension by parents
  • Objection of the child
  • Child under guardianship, curatorship or foster care
  • Child not on containment : child cared for outside his home everyday (in school and hospital daycare for example).

结局指标

主要结局

Comparison of sleep quality during COVID-19 containment between children usually followed in child psychiatry and children without follow-up

时间窗: An average of 1 day

Sleep quality is assessed in both groups with the Sleep Disturbance Scale for Children (SDSC scale). A score ≥ 45/125 is considered as pathological.

次要结局

  • Assessment of sleep disturbance based on psychiatry diagnoses in the group of children usually followed in child psychiatry(An average of 1 day)
  • Assessment of child depression in both groups(An average of 1 day)
  • Assessment of child anxiety in both groups(An average of 1 day)
  • Assessment of child anxiety based on psychiatry diagnoses in the group of children usually followed in child psychiatry(An average of 1 day)
  • Assessment of the influence of socio-demographic factors on sleep in both groups(An average of 1 day)
  • Measure of the correlation between child sleep quality and parents sleep quality (anxiety level) in both groups(An average of 1 day)
  • Assessment of child depression based on psychiatry diagnoses in the group of children usually followed in child psychiatry(An average of 1 day)

研究者

发起方
Hôpital NOVO
申办方类型
Other
责任方
Sponsor

研究点 (1)

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