ACTRN12622000546752
Recruiting
未知
Healthy Ears: A telehealth-facilitated randomised-controlled trial utilising a health promotion intervention to resolve otitis media with effusion for children on specialist Ear, Nose and Throat (ENT) waiting lists.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Otitis Media with Effusion
- Sponsor
- Telethon Kids Institute
- Enrollment
- 250
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Children aged between three years old and seven years old.
- •2\.Children identified during the triage of initial referral to PCH for hearing or ear\-related presenting complaints.
- •3\.Children who have the capacity to comply with study procedures, including follow up, regardless of residential geographical location.
- •4\.Children who have been assessed and subsequently confirmed persistent otitis media with effusion (greater than or equal to 3 months) within a twelve month period as well as the following clinical criteria:
- •a)Type B tympanometry,
- •i.Unilateral or bilateral
- •ii.With or without hearing loss.
Exclusion Criteria
- •1\.Children who are known to be scheduled to undergo surgical intervention within four weeks.
- •2\.Children who have been diagnosed with any of the following complex medical conditions which increases the risk of complications; cleft lip and palate, Down syndrome, major chromosomal anomalies, craniofacial anomalies, chronic suppurative otitis media, or congenital ear anomalies.
- •3\.Children who are actively participating in another ear intervention study.
- •4\.Children are unable to comply with relevant study procedures due to any physical, medical, developmental, behavioural or cognitive condition.
- •5\.Guardian(s) decline to cease the use of ear clearing devices for the four\-to\-six\-week duration of the intervention and control, ie. ear syringe, ear candle, ear relief device (EarPopper®), over\-the\-counter ear drops, nasal balloon etc.
- •6\.The child’s legal representative is unwilling or unable to provide informed consent for the minor to participate in the study.
- •7\.The child does not meet the clinical inclusion criteria..
Outcomes
Primary Outcomes
Not specified
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