跳至主要内容
临床试验/NCT05863299
NCT05863299已完成不适用

Sleep Quality of Critically Ill Children Change Trajectory and Prediction Factors: A Prospective Longitudinal Mixed Study

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2022年11月17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
247
试验地点
1
主要终点
Deep sleep time

研究概览

简要总结

This research adopts the uniform parallel hybrid research design; The quantitative data and qualitative data were collected at the same time, and then the quantitative and qualitative data were analyzed respectively. Finally, the two data sets were combined. Comprehensive interpretation of the study issues through complementarity and mutual validation of quantitative and qualitative data.

详细描述

With the progress and development of medical technology, the mortality rate of critically ill children continues to decline. To improve the long-term prognosis of children has become a new goal of modern medicine. Sleep disorders in critically ill children are caused by disease factors, the complex environment of ICU, and various treatment factors, which have seriously affected the patient's rehabilitation and long-term quality of life. Attention should be paid to the sleep disorders in critically ill children. At present, the research on sleep disorders in critically ill patients in China is mostly focused on adults, and the critically ill children are rarely involved, and there is no research related to sleep disorders and recovery tracks of critically ill children. This prospective longitudinal mixed study aims to describe the change trajectory of sleep disorder and recovery in critically ill children and provide suggestions for subsequent clinical workers to formulate reasonable intervention measures.

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
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ① Age 3-12 years;
  • Children who are conscious during ICU,
  • children with Glasgow score of 15

排除标准

  • (1) did not meet the discharge standards, and asked to be discharged;
  • Children with sleep disorder before admission to PICU, that is, those with baseline CSHQ score > 41;
  • The child had a history of mental illness and cognitive impairment.
  • Children with brain injury, coma, disturbance of consciousness, epilepsy and status epilepticus, obstructive sleep apnea hypopnea syndrome; ⑤ Children with hearing and hearing impairment ⑥ICU stay > 30 days.

结局指标

主要结局

Deep sleep time

时间窗: 2023.12.31

Deep sleep time

Mean Total Night Sleep Minutes

时间窗: 2023.12.31

Mean Total Night Sleep Minutes

Children sleep habit questionnaire score

时间窗: 2023.12.31

Children sleep habit questionnaire score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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