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临床试验/NCT05947006
NCT05947006终止不适用

Study of the Impact of the Setting up of a Pediatric Nurse's Consultation on Parental Anxiety During a Febrile Convulsion in Children

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Level of anxiety

研究概览

简要总结

Febrile seizures are considered a very common syndrome presented in the pediatric emergency room. Witnessing these seizures may can cause anxiety in parents and generate them psychological sequelae such as major depressive disorder in the short term, or sleep disorders in the long term.

An appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology and its care, and thus to reduce their anxiety and prevent potential inappropriate or even deleterious behavior and maneuvers towards the child.

详细描述

Febrile seizures occupy a large place in pediatric practice in the emergency room, their prevalence varies between 3 and 8% in children under 7 years old, hence the notion of a very common syndrome.

When parents witness this event, they can experience it as terrifying, and which can alone cause anxiety and generate psychological sequelae. In the literature, it is described that a third of the parents present a major depressive disorder after the event and a third of the parents still describe sleep disorders after one year.

After the arrival at the pediatric emergency room following the febrile seizure, the priority is given to the care of the child and parents are given succinct medical information. Due to parental anxiety, which may still be significant at this time, this information may not be understood. All of this can make the parent's level of knowledge about this pathology and its management low, potentially leading to future behaviors and maneuvers (such as shaking) that are inappropriate or even harmful to the child.

A different course with appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology, its care and to reduce parent's anxiety. This is why the CONSULFE childcare consultation is proposed in this research.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Participant being an adult parent who attended the febrile seizure of their child aged 1 to 5, episode lasting less than 15 minutes occurring within 24 hours
  • Participant having signed the free and informed consent
  • Affiliation to a social security scheme

排除标准

  • Parent who already has experience of febrile seizures in one of the siblings
  • Parent of a child with a convulsive or neurological history
  • Non-French speaking parents
  • Parent with a diagnosed psychiatric illness
  • Parent benefiting from a legal protection measure
  • Parent participating in a study related to the management of anxiety

结局指标

主要结局

Level of anxiety

时间窗: Baseline and 6 hours after the intervention

Change in the level of anxiety felt at the beginning and at the end of the visit to the emergency room by parents during standard treatment vs parents following the CONSULFE consultation. The level of anxiety is measured with the State-Trait Anxiety Inventory (STAI), with a minimum value of 20, meaning no or low anxiety, and a maximum value of 80, meaning high anxiety.

次要结局

  • Parent's level of anxiety at the departure of the emergency room(6 hours after the intervention)
  • Satisfaction of parents with intervention(6 hours after the intervention)
  • Long term parent's level of anxiety(1 month after the intervention)
  • Long term parent's level of post-traumatic stress(1 month after the intervention)
  • Cost of the intervention(1 month after the intervention)
  • Parent's level of anxiety upon arrival on the emergency room(Baseline)
  • Parent's socio-economic position(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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