跳至主要内容
临床试验/NCT00841022
NCT00841022已完成不适用

Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2009年2月最近更新:
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
115
试验地点
2
主要终点
Level of anxiety scale (STAIC-S)

研究概览

简要总结

This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.

Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.

研究设计

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

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Male or female children between 6 to 16 years and 11 month old.
  • Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma).
  • Children with a high, normal or light level of verbal comprehension (normal academic level or less than two repeating).
  • Children coming with their parents.

排除标准

  • Previous surgery.
  • Unwillingness to participate (parents or child)

研究组 & 干预措施

1

Experimental

Information of children with comic leaflet

干预措施: Information with comics (Other)

2

No Intervention

结局指标

主要结局

Level of anxiety scale (STAIC-S)

时间窗: before preanaesthesia consultation and after preanaesthesia consultation

次要结局

  • Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)(before preanaesthesia consultation)
  • Level of anxiety scale (STAIC-T)(Before preanaesthesia consultation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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