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
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
- 55
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
No clown
No Intervention
Routine venipuncture without distraction
Clown
Active Comparator
A medical clown is present in the procedure room during venipuncture
干预措施: Clown (Behavioral)
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
研究点 (1)
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