NCT02490995已完成不适用
Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.
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
- 80
- 试验地点
- 1
- 主要终点
- The Yale Preoperative Anxiety Scale (m-YPAS)
研究概览
简要总结
The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.
This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who need a surgery
- •Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.
- •Old patient under age 12
- •Patient whose parents agreed to participate
排除标准
- •Patient with psychomotor limitations
- •Patient that had already been hospitalised for a surgery
研究组 & 干预措施
Group A
No Intervention
Information given by the anaesthetist during the consultation
Group B
Experimental
Movie + Information given by the anaesthetist during the consultation
干预措施: Movie (Other)
结局指标
主要结局
The Yale Preoperative Anxiety Scale (m-YPAS)
时间窗: the 1 surgery day at the time of the separation parents-children
Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)
次要结局
- Induction Compliance Checklist (ICC)(intraoperative)
- The agitation in recovery room(First 15 minutes of the arrival in recovery room)
- psychometric validation of the SAS (self anxiety scale)(up to postoperative day 30)
研究者
研究点 (1)
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