Clinical Trials Directory

Trials / Completed

CompletedNCT05543031

Effect Of Music Integrated Phonological Awareness Program On Preschool Cochlear Implant Users

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Uskudar University · Academic / Other
Sex
All
Age
5 Years – 7 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMusic-Integrated Phonological Awareness training programWe would like 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. The program is prepared as 10 lessons. Participants were guided through online training for 5 weeks, with 20-minute sessions conducted weekly. The training was carried out via Zoom, a free virtual interview program. Each family had a computer.
DIAGNOSTIC_TESTSpectral-Temporally Modulated Ripple Test (SMRT)Spectral-Temporally Modulated Ripple Test (SMRT) was used to assess the spectral discrimination ability of the study group.Speech stimuli were presented at a calibrated presentation level of 60 dB SPL in a quiet room. The child was positioned at 0° azimuth and 1-meter from the loudspeaker.
DIAGNOSTIC_TESTThe Phonological Awareness Scale of Early Childhood Period (PASECP)The Phonological Awareness Scale of Early Childhood Period (PASECP) was used to measure the sound awareness and sound discrimination skills of study group pre-post training. The test has 8 sub-dimensions.
DIAGNOSTIC_TESTMismatch Negativity TestMismatch Negativity (MMN) was used to evaluate the central auditory system.The test was used for electrophysiological recordings of the study group.The standard stimulus presented as /ba/ (%80), and the rare stimulus presented as /da/ (%20) frequency. The onset (rise) and offset (fall) times of the stimuli are 10 ms, and the plateau time is 50 ms. The interval between stimuli for both responses was 1.1 ms. A 0.1-30 Hz filter was applied. The speech stimuli intensity was 70 dB SPL. Speech stimuli were presented at a 1-meter distance from the participant, with speakers placed at an angle of 0°.
DIAGNOSTIC_TESTEarly Language Development (TELD-3)Test of Early Language Development (TELD-3) measured children's receptive and expressive language skills both group for inclusion criteria.

Timeline

Start date
2021-03-18
Primary completion
2021-06-02
Completion
2021-07-16
First posted
2022-09-16
Last updated
2022-09-16

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05543031. Inclusion in this directory is not an endorsement.