Perth Children's Hospital (PCH) 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.

Not Applicable

Recruiting

• Conditions: Otitis Media with Effusion; Ear - Other ear disorders

• Registration Number: ACTRN12622000546752
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-07
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

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..

Study & Design

• Study Type: Interventional
• Study Design: Not specified