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Auditory training randomised controlled trial after grommet insertion

Effectiveness of auditory training after grommet insertion in improving auditory processing skills: a prospective randomised trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000041358
Enrollment
40
Registered
2026-01-12
Start date
2026-03-23
Completion date
2027-07-30
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project proposes a structured auditory training program focused on phonemic awareness skills, delivered in a school setting to children recently treated for chronic OME via grommet insertion. The objective of this study is to evaluate if a structured phonemic awareness training program improves the auditory processing skills in children with documented history of OME, compared to standard care (no intervention). The project will act as a pilot to determine whether significant improvements in auditory processing skills are achieved through the proposed auditory training programme and inform larger scale studies.

Interventions

This study is a randomised trial using parallel groups with equal numbers of participants in each group. The research team recruiting and assessing outcomes will be blinded to grouping, but the participants, their families and teachers, and the research assistant providing the intervention will not be blinded. The intervention is a NZ-adapted electronically-delivered Auditory Training programme. This programme will be delivered over a 10 week period during the NZ school terms to children atten

This study is a randomised trial using parallel groups with equal numbers of participants in each group. The research team recruiting and assessing outcomes will be blinded to grouping, but the participants, their families and teachers, and the research assistant providing the intervention will not be blinded. The intervention is a NZ-adapted electronically-delivered Auditory Training programme. This programme will be delivered over a 10 week period during the NZ school terms to children attending primary schools in South Auckland (Counties Manukau). The programme is a phoneme training system lasting about 45 minutes per session. Each session will focus on training a set of specific phonemes through interactive and engaging video content. The video uses existing content adapted with a Maori/New Zealand voice-over. A research assistant is present with the child and actively monitors engagement and attention. The child is asked to tap the screen in response to directions from the video content. The research assistant will provide ongoing motivation during the session. Each session will cover 3 or 4 phonemes to include a mix of long or short vowels and consonants (total of 37 phonemes covered over the programme). A total of 12 sessions will be delivered to each participant at semi- regular intervals (approximately every 4 school days) over a 10 week period at the child participant's usual school. The location will be in a quiet space according to the school's preference and facilities, eg. library, empty classroom. The programme will be delivered in person to individual child participants using an iPad or similar and supervised by a Research Assistant. The control group will receive standard care and no interventions except the usual educational care provided by their school.

Sponsors

Health NZ Counties Manukau
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

Recruitment will include children who meet the following criteria: • Reside in the Counties Manukau catchment area and attend school within the district. (If the whanau relocates outside of the district during the study period, they will remain in the study if the child participant continues to attend a local school). • Aged 6-8 years old at entry to study AND in years 1-3 at primary school • Received bilateral grommets through Counties Manukau Otolaryngology (ORL) department and had documented effusion in one or both ears at surgery. • History of at least 6 months documented otitis media with effusion (OME) in one or both ears prior to surgery • History of at least mild (Pure Tone Audiometry average>25dBHL) in one or both ears prior to surgery • Normal bilateral hearing at post-op visit with bilateral patent and in situ grommets

Exclusion criteria

Exclusion criteria includes: • Children with bilateral aerated middle ear cavities at surgery • Children waitlisted with primary indication of Recurrent Acute Otitis Media for grommets • Children with normal hearing in both ears before surgery • Children with short OME duration < 6 months • Children who are nonverbal or without spoken language • Children with known diagnosis of Auditory Processing Disorder • Children with known underlying permanent hearing loss • Children with cleft palate or other craniofacial abnormalities • Children with down syndrome or other developmental disorders

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026