跳至主要内容
临床试验/NCT00609960
NCT00609960已完成不适用

Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
anxiety level

研究概览

简要总结

This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia. We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use

详细描述

The perioperative environment, often anxiety-provoking for adults, may be quite frightening for children. The detrimental effects of preoperative anxiety are not confined to the preoperative period. Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54% of children.

Many preoperative systems allow parental, pharmacologic, and anticipatory interventions to facilitate a relaxed perioperative environment for children. Unfortunately, scheduling conflicts, side effects, and limited resources conspire to limit their usefulness. For example, only 10% of respondents in a recent survey used parental presence during induction of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same survey, only 50% of children undergoing surgery receive sedating premedication. (Kain). Distraction techniques, such as the use of toys or video games, may also decrease perioperative anxiety, however their effectiveness during induction of anesthesia is not well characterized. The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones. Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population. We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction.

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 (Care Provider)

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I and II
  • Children aged 2-8 years

排除标准

  • Previous surgery
  • ASA > II
  • Parents' refusal

研究组 & 干预措施

2

Active Comparator

midazolam a anxiolytic drug was given in the preoperative phase

干预措施: midazolam (Drug)

3

Active Comparator

clowns where present during the preoperative phase

干预措施: clowns present (Behavioral)

结局指标

主要结局

anxiety level

时间窗: waiting area and enterance to OR -1 hour

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

Loading locations...

相似试验

Clowns as Treatment for Preoperative Anxiety in... | 临床试验