Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
研究概览
简要总结
Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Anxiety will be determined by using a video recording of the child, which will be assessed by psychiatric
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.
排除标准
- •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
研究组 & 干预措施
Midazolam
Children will be premedicated with usual treatmente (midazolam)
干预措施: Midazolam (Drug)
TIBD Tablet-based video distraction
Children will receive of tablet-based interctive games in preoperatory room
干预措施: TIBD (Device)
结局指标
主要结局
Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
时间窗: 6 hours
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.
次要结局
- Changes in postoperative behavior(10 days)
- Emergence delirium(1 hour)
- Parents Satisfaction(10 minuts)
- Cooperation with the induction(30 minuts)
研究者
Nathalie Lopez
Principal Investigator
Universidad de Valparaiso