跳至主要内容
临床试验/NCT00535457
NCT00535457撤回1 期

The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children

Sheba Medical Center2 个研究点 分布在 1 个国家开始时间: 2007年9月26日最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
anxiety scores

研究概览

简要总结

It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate.

Study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks.

  1. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 3-12 years
  • minor surgeries / diagnostic procedures such as endoscopy, biopsy

排除标准

  • children that do not speak Hebrew
  • American Society of Anesthesiologists (ASA) status above II
  • a need for regional anesthesia only
  • a need for an intravenous (IV) cannulation at the induction room or operating room before the induction of anesthesia.

结局指标

主要结局

anxiety scores

时间窗: Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome.

postoperative maladaptive behavior rate

次要结局

  • preoperative anxiety scores and rate of postoperative maladaptive behavior

研究者

申办方类型
Other Gov

研究点 (2)

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