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临床试验/NCT03954522
NCT03954522已完成不适用

Evaluation in Children of the Psychological Impact of the Visit of a Hospitalized Relative in ICU

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年9月26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
57
试验地点
2
主要终点
Chronic psychotraumatic impact of the visit on the child

研究概览

简要总结

According to literature, it's difficult to evaluate the impact of the visit of the child in ICU. Currently, no recommendations are available regarding welcome and accompany children who visit their relative hospitalized in ICU. Collaboration between humanities and medical sciences brings to this question a complementary look. Majority of studies investigated the question of the impact of young child ICU visit in a unidirectional linear causality scheme visit = psychopathological impact. The visit of the child in ICU should not be considered as an isolated event whose objective characteristics would be alone vectors of trauma. Contrary, the child visit must be apprehended in relation to the quality of the supports on which the child can count. The investigators hypothesize that children can overcome the visit of a kin hospitalized in ICU if accompanying people can support the child and contain, before and after the visit, the emotions of the child.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • family groups in which at least one child aged 6 to 14 years having expressed the wish to visit his/her hospitalized relative
  • family groups in which the non-hospitalized parent has expressed the wish to accompany his/her child during the visit
  • parent hospitalized in ICU is at least 18 years old
  • informed consent of children, non-hospitalized and/or hospitalized relatives
  • informed consent of the accompanying caregiver

排除标准

  • moribund patient
  • child unaccompanied by his/her parent/relative during the visit
  • non-hospitalized non-French-speaking parent/relative (need to be able to answer the questionnaires)
  • child benefiting from a psychological follow-up prior to the hospitalization of his/her parent
  • non French-speaking child
  • child under 6 years old or older than 14
  • hospitalized relative who died before the proposed interview with the child (particular attention will be carry out to the interview conditions. The loss of the hospitalized parent will not allow for an interview on the experience of the visit).

研究组 & 干预措施

Expérimental

Experimental

psychologist interview and psychometrics scales

干预措施: interview (Other)

结局指标

主要结局

Chronic psychotraumatic impact of the visit on the child

时间窗: 1 month

Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant

Parental, family and caregiver support provided to the child during and following the visit

时间窗: 1 month

semi directive interviews of caregiver/family

Psychological experience of the visit according the child age

时间窗: 1 month

semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old

Psychological experience of the visit for the child

时间窗: 7 days

semi directive interview

Acute psychotraumatic impact of the visit on the child

时间窗: 7 days

Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant

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 (2)

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