Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial (TABLET)
Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial
研究概览
详细说明
It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.
For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.
There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Nathalie López, MD
- 电话号码：2364000
- 邮箱：nathalielopez.jq@gmail.com
研究联系人备份
- 姓名：Anamaria Correa, MD
- 电话号码：2364000
- 邮箱：anamaria.correa@uv.cl
学习地点
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Valparaiso、智利、2341131
- 招聘中
- Hospital Carlos Van Buren
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接触：
- Nathalie Lopez, M.D.
- 电话号码：2364000
- 邮箱：nathalielopez.jq@gmail.com
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接触：
- Anamaria Correa, M.D.
- 邮箱：correanamaria@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.
Exclusion Criteria:
Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TIBD Tablet-based video distraction
Children will receive of tablet-based interctive games in preoperatory room
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Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.
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有源比较器：Midazolam
Children will be premedicated with usual treatmente (midazolam)
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Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
大体时间：6 hours
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Difference between the measurement of the mYPAS-SF applied in the preoperative time and prior to induction. The scale has 18 items in 4 categories. Maximum score is 100 points. The higher the score, the greater the anxiety. |
6 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cooperation with the induction
大体时间：30 minuts
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Scale with 10 items, 1 point for each one. 0 points shows an induction with perfect cooperation. This scale will be applied at the moment of the induction by the anesthesiologist |
30 minuts
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Changes in postoperative behavior
大体时间：10 days
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The Post Behavioral Behavior Change Questionnaire (PHBQ) will be applied at the postoperative surgical control (7-10 days after the intervention).
This survey will be applied by people trained by the hospital's pediatric psychiatry team The higher the score, the more behavioral changes in the postoperative period
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10 days
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Emergence delirium
大体时间：1 hour
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In the post-anesthesia recovery unit, the Emergency Delirium Scale for Pediatric Anesthesia (PAED) will be applied every 15 minutes during the first 30 minutes of their stay in the unit.
Score goes from 0 to 20.
Scores greater than 10 is considered as delirium.
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1 hour
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Parents Satisfaction
大体时间：10 minuts
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A gradual scale will be applied to the parents of the patient upon discharge from hospital.
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10 minuts
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合作者和调查者
调查人员
- 研究主任：Nathalie López, MD、Universidad de Valparaíso Chile
- 首席研究员：Anamaria Correa, MD、Universidad de Valparaíso Chile
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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