NCT04200196已完成不适用
Improvement of Anxiety Management During a Venous Puncture About Children 3 to 6 Years, With a Participatory Entertainment Method
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- modified Yale Preoperative Anxiety Scale (mYPAS)
研究概览
简要总结
The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire".
详细描述
The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire".
the study will compare the "fabrique à histoire"(Lunii(R)) with the usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 3 to 6 years in pediatric emergency needing to venous puncture
- •Oral consent by children
- •Informed and signed consent by tenured of parent authority
- •To have Anaesthetic patch 45 minutes or more before the venous puncture
排除标准
- •To have Anaesthetic patch less than 45 minutes before the venous puncture because of necessity to blood test or an other emergency
- •Necessity to analgesic 3 emergency
- •Necessity to MEOPA
- •Minor parents
- •Assessment of anxiety is not possible because of comorbidity
- •Anterior participation to these study
结局指标
主要结局
modified Yale Preoperative Anxiety Scale (mYPAS)
时间窗: through study completion, an average of 2 hours
Evolution of mYPAS (validated anxiety scale with a scale 23,3 (no anxiety) to 100 (max of anxiety) between T0 and T2 (after venipuncture). mYPAS is quoted by an extern observator.
次要结局
- Children face scale(through study completion, an average of 2 hours)
- FLACC Scale(through study completion, an average of 2 hours)
- Parent anxiety assessment(through study completion, an average of 2 hours)
- Parent pain assessment(through study completion, an average of 2 hours)
- Number of venous puncture before success(through study completion, an average of 2 hours)
- Venous puncture success(through study completion, an average of 2 hours)
- Time before venous puncture success(through study completion, an average of 2 hours)
- Caregivers feedback(through study completion, an average of 2 hours)
- Parents feedback(through study completion, an average of 2 hours)
研究者
研究点 (2)
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