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临床试验/NCT01622218
NCT01622218已完成不适用

The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study

Soroka University Medical Center3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012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
50
试验地点
3
主要终点
Children: WBS (Wong Baker Faces Pain Rating Scale)

研究概览

简要总结

The purpose of our study to quantitatively examine the stress levels prior to surgery and the use of analgesics post surgery in both children and their parents following a preoperative intervention with a medical clown compared to children that were not exposed to this intervention.

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
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ages 4-10 years old
  • undergoing elective umbilical or inguinal hernia repair surgery
  • ASA Physical Status = 1

排除标准

  • 未提供

结局指标

主要结局

Children: WBS (Wong Baker Faces Pain Rating Scale)

时间窗: 24 hours

measure at 4 time points (repeated measures) - at admission, discharge, 12 and 24 hours.

次要结局

  • Cytokines levels(End of precedure, before waking up)
  • Use of analgesics(During the 24 hours following the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nitza Heiman Newman, MD

Principle Investigator

Soroka University Medical Center

研究点 (3)

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