跳至主要内容
临床试验/NCT01396876
NCT01396876已完成不适用

Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年7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
60
试验地点
2
主要终点
Pain score

研究概览

简要总结

The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.

详细描述

Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.

研究设计

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

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children needing venous blood sampling or the insertion of an intravenous canula

排除标准

  • Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
  • Absence of a parent during the procedure
  • Abnormal development according to parents

研究组 & 干预措施

No clown

No Intervention

Clown

Active Comparator

A clown is present during venipuncture

干预措施: clown (Behavioral)

结局指标

主要结局

Pain score

时间窗: at the end of the procedure

recorded by the child

次要结局

  • Overall report of procedure's comfort(at the end of the procedure)
  • Parental anxiety level(at the end of the procedure)
  • Procedure's success rate(at the end of the procedure)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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