Family MobilePhone Otoscopy in Diagnostics of Otitis Media (FamilymOTO)

Turku University Hospital (TYKS)

Status: Completed

Conditions: Otitis Media

Treatments: Other: Teaching; Device: (CellScopeOTO)

Study type: Interventional

Funder types: Other

Identifiers

NCT02452164

T91/2015

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Teaching group

Active Comparator group

Description:

Parents are taught to conduct cellphone otoscopy and if necessary study physician removes cerumen from childrens´ ear canals at the first study visit.

Treatment:

Other: Teaching

Device: (CellScopeOTO)

Control group

Other group

Description:

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.

Treatment:

Device: (CellScopeOTO)