Family MobilePhone Otoscopy in Diagnostics of Otitis Media

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Other: Teaching; Device: (CellScopeOTO)

• Registration Number: NCT02452164
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Study Start: 2015-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teaching group	(CellScopeOTO)	Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.
Teaching group	Teaching	Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.
Control group	(CellScopeOTO)	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.

Primary Outcome Measures

Name	Time	Method
diagnostic quality of tympanic membrane imagines	first study week	diagnostic quality of tympanic membrane imagines obtained by parents with cellphone otoscope

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland