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临床试验/NCT02452164
NCT02452164已完成不适用

Family MobilePhone Otoscopy in Diagnostics of Otitis Media. (Family mOTO-Study)

Turku University Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年9月最近更新:
适应症

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

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

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

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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