Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- diagnostic quality of tympanic membrane imagines
研究概览
简要总结
This is a one-center clinical study carried out in Turku, Finland. The study patients will be randomly allocated to one of the two parallel study groups (teaching group and control group). The hypothesis is that the diagnostic quality of tympanic membrane imagines is better when parents have been taught to conduct middle ear examination with a cellphone otoscope (CellScopeOTO) as compared to no teaching. Furthermore, this study aims at evaluating the diagnostic feasibility of cellphone otoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 - 35 mo
- •Parents have iPhone 5, 5s or 6
- •Child is in daycare
- •Child has had at least one acute otitis media within 90 days preceding the enrollment
- •Family agrees to give a mortgage of 40 euros from the CellScopeOTO
排除标准
- •Tympastonomy tube present in tympanic membrane
- •Chronic perforation of the tympanic membrane
- •Condition of head/neck anomaly to affect middle ear or ear canal anatomy
- •One child from the family already participating
研究组 & 干预措施
Teaching group
Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.
干预措施: Teaching (Other)
Teaching group
Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.
干预措施: (CellScopeOTO) (Device)
Control group
Families receive the cellphone otoscope as if they had bought it themselves from the internet. After the first study week, parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals.
干预措施: (CellScopeOTO) (Device)
结局指标
主要结局
diagnostic quality of tympanic membrane imagines
时间窗: first study week
diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope
次要结局
未报告次要终点