The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
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.
2. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.
研究概览
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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Tel Hashomer、以色列、52621
- Sheba Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age 3-12 years
- minor surgeries / diagnostic procedures such as endoscopy, biopsy
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1
Children will watch tricks ("magic") before anesthesia induction
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Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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anxiety scores
大体时间: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.
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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.
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postoperative maladaptive behavior rate
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次要结果测量
结果测量 |
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preoperative anxiety scores and rate of postoperative maladaptive behavior
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合作者和调查者
调查人员
- 首席研究员:Ze'ev Shenkman, MD、Sheba Medical Center
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SHEBA-07-4786-ZS-CTIL
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Preoperative Magic Tricks的临床试验
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University Hospital, Strasbourg, France招聘中
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Fondazione Evidence per Attività e Ricerche Cardiovascolari...招聘中
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Concept Medical Inc.完全的