Clinical trial NCT05543031: Effect Of Music Integrated Phonological Awareness Program On Preschool Cochlear Implant Users
Official title: Effect Of Music Integrated Phonological Awareness Program On Preschool Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telerehabilitation
Keywords: Phonological awareness training
music
cochlear implant
telerehabilitation
mismatch negativity
Lead sponsor: Uskudar University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2022-09-16
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed to determine the benefit of music integrated phonological awareness programs for children using cochlear implants. In addition, the phonological skills and language skills of children using cochlear implants and children with normal hearing were compared in the pre and post-training results.
Primary purpose: OTHER

Brief summary: The aim was to observe the effect of the music integrated phonological awareness program on preschool cochlear implant users and to compare the phonological awareness skills of the study group with the control group before and after the online training.

Detailed description: This study was designed to determine the benefit of music integrated phonological awareness programs for children using cochlear implants. In addition, the phonological skills and language skills of children using cochlear implants and children with normal hearing were compared in the pre and post-training results. Test of Early Language Development (TELD-3), The Phonological Awareness Scale of Early Childhood Period (PASECP), Mismatch Negativity (MMN) was used in this study.

This study was carried out with follow-up patients in the Audiology, Language and Speech Disorders Clinic of xxx University - Medical Faculty, Department of Otorhinolaryngology. The study was performed with the approval of Ethics Committee, and written informed consent was obtained from all patient families (138955/ July 2021). There are 9 female and 14 male cochlear implant users in the study group; 9 female and 14 male children with normal hearing in the control group. Children ranging in age from 5 to 7 who also have 5-6 years old language skills without any neurological problems were included in the study. Cochlear implant mappings of all children were checked before the training.

SPSS 25.0 (IBM) was used for statistical analysis. Pre and post-training comparisons of The Phonological Awareness Scale of Early Childhood Period, SMRT, and Mismatch Negativity tests were analyzed with the Wilcoxon test. The correlation of numerical measurements with each other was examined with Spearman Correlation. The differences in the numerical measurements used in the research according to the binary demographic categories were analyzed with the Mann-Whitney U test. The differences according to the multiple categories were analyzed using the Kruskal Wallis H test. The significance level (α=0,05) was used.

Eligibility criteria: Inclusion Criteria:

* For children with hearing loss
* Bilateral severe sensorineural hearing loss
* Having unilateral or bilateral cochlear implants,
* Having a chronological age in the range of 5-7 years,
* Not having started primary school.
* Using the cochlear implant and regularly
* To receive regular training in the auditory rehabilitation center

For children with normal hearing:

* To have normal hearing,
* To have receptive and expressive language skills compatible with the chronological age in the language test to be performed.
* Not starting primary school

Exclusion Criteria:

* In case of not having any without being accepted for control and study,
* Having additional disability
* Using drugs affecting the auditory system

Primary outcomes:
measure: Change from Baseline in the phonological awareness skills at 3 Months
timeFrame: baseline and 3 months
measure: Change from Electrophysiological at 3 Months
timeFrame: baseline and 3 months
measure: Change from baseline in the spectral discrimination ability at 3 Months
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
city: Istanbul
country: Turkey
facility: Uskudar University
Study officials:
affiliation: Uskudar University
name: Büşra Yılanlı, Msc
role: PRINCIPAL_INVESTIGATOR
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