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临床试验/NCT01688115
NCT01688115已完成不适用

Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

University of Florence0 个研究点目标入组 40 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Preoperative anxiety

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of a video shown using an iPad, compared to a standard treatment, to reduce preoperative anxiety in children who have to undergo to elective surgery procedure

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
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 6 and 11
  • No cerebral impairment or cognitive impairment
  • Child and his/her family native speaker of Italian
  • admission to the hospital at list one day before the sugery procedure
  • presence of written consent of the parents to the study

排除标准

  • age lower than 6 or upper than 11
  • presence of cerebral impairment or cognitive impairment
  • Child and his/her family are not native speaker of Italian
  • absence of written consent of the parents to the study

结局指标

主要结局

Preoperative anxiety

时间窗: perhaps 24 hours from child admission to surgery procedure

Preoperative anxiety is measured using the "Modified Yale Preoperative Anxiety Scale (m-YPAS)"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Filippo Festini

Professor of Nursing

University of Florence

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