Effectiveness of Animated Cartoons for Improving Cooperation During the Delivery of Inhaled Treatments to Young Children With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Fraction of time during which the child is non-cooperative
研究概览
简要总结
Up to 50% of infants and young children cry during the administration of their inhaled treatment for their asthma. This results in decreased lung deposition, and thus decreased effectiveness of their inhaled treatment.
The objective of this study is to evaluate whether animated cartoons can increase the cooperation of young children with asthma who are not cooperative during the delivery of their ICS therapy through a pMDI/spacer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dyad parent-child.
- •Parent must be 18 years or older and own a smartphone which can record videos and display animated cartoons.
- •Child must be 6-47 months old, and require an inhaled corticosteroid therapy, and use a pressurized metered-dose inhaler and a spacer, and have difficulties in cooperation at least half of the time on the last week.
排除标准
- •Children with a medical history of epilepsy, or visual or hearing impairment not corrected by an appropriate device/treatment.
- •Parents not speaking French or English.
- •Parents not able to run the mobile application used to record the videos of the child despite repeated explanations.
研究组 & 干预措施
Group animated cartoon-black screen (AB)
In this group, children will be exposed to a animated cartoon during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to a black screen in the same conditions for one other week.
干预措施: Animated Cartoon (Other)
Group animated cartoon-black screen (AB)
In this group, children will be exposed to a animated cartoon during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to a black screen in the same conditions for one other week.
干预措施: Black screen (Other)
Group black screen - animated cartoon (BA)
In this group, children will be exposed to a black screen during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to an animated cartoon in the same conditions for one other week.
干预措施: Animated Cartoon (Other)
Group black screen - animated cartoon (BA)
In this group, children will be exposed to a black screen during the delivery of their inhaled treatment twice a day during one week, then they will be exposed to an animated cartoon in the same conditions for one other week.
干预措施: Black screen (Other)
结局指标
主要结局
Fraction of time during which the child is non-cooperative
时间窗: At the end of the three weeks (day 21)
Length of time during which the child is crying or moving outside the mask, divided by the total length of time needed for the delivery of the inhaled treatment
次要结局
- Fraction of time during which the child is crying(At the end of the three weeks (day 21))
- Fraction of time during which the child is moving outside the mask(At the end of the three weeks (day 21))
研究者
David Drummond
M.D.
Hôpital Necker-Enfants Malades