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临床试验/NCT04168827
NCT04168827已完成不适用

Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma of 3 to 6 Months After the Intensive Care Unit Leaving

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Depression, post traumatic stress disorder, anxiety

研究概览

简要总结

This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.

详细描述

With nearly 25% of trauma deaths, trauma is one of the leading causes of death in the world for children aged 5 to 14 years. In children under 4, it is responsible for 6% of deaths.

Severe trauma is defined by an Abbreviated Injury Scale > 3 score in at least one anatomical region.

In case of multiple traumas, the Injury Severity Score is used to define severe polytrauma if it is > 15.

Cranial trauma is the most common lesion found in polytraumatized children and is present in 80% of cases.

Serious head trauma is defined as the existence of a cranial trauma in a patient whose Glasgow score is less than or equal to 8.

研究设计

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

入排标准

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

入选标准

  • Holder of the parental authority of a patient under 18 who has been hospitalized in the surgical intensive care unit of Necker University Hospital for severe trauma (Abbreviated Injury Scale greater than or equal to 3 in one of the anatomical regions) at the admission in the service and regardless of the ending of hospitalization.
  • Holder of parental authority over 18 years.
  • Holder of parental authority speaking French.

排除标准

  • Holder of parental authority refusing to participate in the study, after submission of the information document.
  • Holder of parental authority unable to answer the questionnaire.

研究组 & 干预措施

Relatives of severe traumatized child

Relatives of a child who has been hospitalized in intensive care of Necker hospital following a severe trauma

干预措施: Questionnaire (Behavioral)

结局指标

主要结局

Depression, post traumatic stress disorder, anxiety

时间窗: 18 months

Composite criterion considered positive if : The subject obtains a score greater than or equal to 13 in the Hospital Anxiety and Depression Scale questionnaire, thus defining a state of anxiety and depression. Hospital Anxiety and Depression Scale score range from 0 to 42 with higher scores indicating worse symptoms. and / or The subject obtains a score greater than or equal to 8 on one of the of the Hospital Anxiety and Depression Scale score. The Hospital Anxiety and Depression Scale score is separated in two section, one for Anxiety and one for depression. Each subscales range from 0 to 21 with higher scores indicating worse symptoms. and / or The subject obtains a score greater than or equal to 30 in the Impact of Event Scale Revised questionnaire defining high risk of presence of a post-traumatic stress disorder. The Impact of Event Scale Revised scores range from 0 to 88, with higher scores indicating worse symptoms.

次要结局

  • Feeling of hospitalization(18 months)
  • Socio-demographic analysis(18 months)
  • Predictive factors for the occurrence of mental disorders(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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