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临床试验/NCT05948488
NCT05948488已完成不适用

Psychological Study of the Links Between Feeling and Fear of Pain, Anxiety and Quality of Life in Children With Mucoviscidosis

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年2月28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
160
试验地点
1
主要终点
Links between pain during care and anxiety

研究概览

简要总结

Cystic fibrosis is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression.

The aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.

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
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Have cystic fibrosis
  • Child aged over 8 years and under 18 years
  • Presence of at least one parent at the time of inclusion
  • To be present for a scheduled hospitalisation at the Resources and Competence Centres for Cystic Fibrosis
  • Do not object to the research

排除标准

  • Under 8 or over 18 years of age
  • Lack of at least one parent at the time of inclusion
  • Presence of chronic co-morbidities
  • Difficulty reading and understanding French
  • Objection to taking part in research

结局指标

主要结局

Links between pain during care and anxiety

时间窗: 1 day

Pain during care is assessed using the Visual Analogic Scale (VAS) and anxiety using the State Trait Anxiety Inventory (STAI) scale. The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain". The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.

次要结局

  • Links between pain during care and the severity of the disease(1 day)
  • Links between the severity of the disease and anxiety(1 day)
  • Links between pain-related fears and pain during care(1 day)
  • Links between pain during care and quality of life(1 day)
  • Links between parents' anxiety and the child's anxiety(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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