The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing
Secretory Otitis Media, Acute Otitis Media
About this trial
This is an interventional treatment trial for Secretory Otitis Media focused on measuring Conductive hearing loss, middle ear pressure equalization, middle ear effusion
Eligibility Criteria
Inclusion Criteria:
- Unilateral or bilateral middle ear effusion with resultant conductive hearing loss one week after acute otitis media.
- Intact tympanic membranes bilaterally.
- Acceptable level of written and spoken swedish language skills.
Exclusion Criteria:
- Comorbidity,
- Perforated acute otitis media or other complications of acute otitis media.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Moniri Otovent
Control
A face mask is connected to a tube to which a coloured balloon is attached. The tube is also connected to ambu bag balloon. A safety valve is used to prevent too high air pressure. The ambu bag balloon is hidden in a green soft toy in the form of frog. The parent and the child hold the face mask against the mouth and the child blows the balloon. On need, mainly in the beginning of treatment course, the parent presses the frog's abdomen in order to fill the balloon with air. On the first day, a low pressure balloon is used, then it is changed with a higher pressure balloon. If no effect is noticed, (the child should experience clicking sound in one or both ears) after day 3, the balloon is replaced with a new balloon with additionally higher pressure. Full compliance for the treatment is defined as 20 blows (5 minutes) in the morning and evening for one week.
No intervention is used in this group.