The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The level of anxiety experienced by children undergoing allergy skin tests and receiving application of local anesthetic cream and/or care and treatment from medical clowns
研究概览
简要总结
Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing this procedure. The investigators intend to examine if medical clowns compared with local anesthetic cream can decrease these feelings in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any child undergoing allergy prick skin test
排除标准
- •Children suffering from coulrophobia (phobia of clowns)
- •Children with a known hypersensitivity to EMLA 5% cream
- •Children who have undergone a painful medical procedure (surgery, dental procedures, blood drawing) over the past 3 months
- •Children who, for medical reasons, must have their skin test performed on an area other than the volar aspect of the arm
研究组 & 干预措施
Placebo cream, Skin test, Anxiety, Pain
After placing a placebo cream on both arms, pain and anxiety resulting from performing allergy skin test on one of the arms will be evaluated
干预措施: Cream of Macrogol cetostearyl ethers (Biological)
Anesthetic cream, pain and anxiety, skin test
After placing a placebo cream on one arm and anesthetic cream on the second arm, pain and anxiety resulting from performing allergy skin test on the second arm will be evaluated
干预措施: Cream of Lidocaine 2.5 %.and Prilocaine 2.5 % (Drug)
Medical clown, placebo cream, skin test
After placing a placebo cream on both arms and after receiving care and treatment from a medical clown, pain and anxiety resulting from performing allergy skin test on one of the arms will be evaluated
干预措施: Care and treatment from a medical clown (Behavioral)
Medical clown, Anesthetic cream, Skin test
After placing a placebo cream on one arm and anesthetic cream on the second arm and after receiving care and treatment from a medical clown, pain and anxiety resulting from performing allergy skin test on the second arm will be evaluated
干预措施: Care and treatment from a medical clown (Behavioral)
结局指标
主要结局
The level of anxiety experienced by children undergoing allergy skin tests and receiving application of local anesthetic cream and/or care and treatment from medical clowns
时间窗: 1.5 hour
次要结局
- Severity of pain experienced by these children(1.5 hour)