The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 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
- 否
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
研究组 & 干预措施
Medical Clown
Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers.
干预措施: Medical Clown (Behavioral)
Control
Assessment of child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect on the total consumption of analgesics and on the post- surgery inflammatory markers.
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
Nitza Heiman Newman, MD
Principle Investigator
Soroka University Medical Center