跳至主要内容
临床试验/NCT02168998
NCT02168998已完成不适用

Level of Cortisol in Stress Response During Intravenous Access in the Pediatric Emergency Department With a Medical Clown: a Randomized Prospective Pilot Study

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年8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
55
试验地点
2
主要终点
Blood Cortisol level

研究概览

简要总结

The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.

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
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients needing venous blood sampling or insertion of an intravenous canula
  • Normal development according to parents

排除标准

  • Critically ill children (e.g. shock, respiratory distress or failure)
  • Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)
  • Known adrenal or pituitary disease
  • Children who have received glucocorticoids during the preceeding six weeks

结局指标

主要结局

Blood Cortisol level

时间窗: During intravenous cannulation or blood sampling

次要结局

  • Vital signs (heart rate, respiratory rate, blood pressure)(During intravenous cannulation or blood sampling)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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