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Completed

NCT Number: NCT05543031

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

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.

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Key information

Conditions

Telerehabilitation

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music-Integrated Phonological Awareness training program

Other

We 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.

Spectral-Temporally Modulated Ripple Test (SMRT)

Diagnostic Test

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.

The Phonological Awareness Scale of Early Childhood Period (PASECP)

Diagnostic Test

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.

Mismatch Negativity Test

Diagnostic Test

Mismatch 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°.

Early Language Development (TELD-3)

Diagnostic Test

Test of Early Language Development (TELD-3) measured children's receptive and expressive language skills both group for inclusion criteria.

Primary outcomes

  1. Change from Baseline in the phonological awareness skills at 3 Months

    Time frame: baseline and 3 months

    The Early Childhood Phonological Awareness Scale (PASECP) was used to measure sound awareness and sound discrimination skills of preschool children whose language age is between 60-72 months. The test has 8 sub-dimensions. There are 8 test items in the first sub-dimension and 10 test items in the other sub-dimensions, with a total of 78 test items. If the answers given by the children to the scale items are correct (1), if incorrect (0), they are coded into the answer key. The test is administered to children individually. The application time for each child takes approximately 15 minutes. High scores of the child indicate that his/her phonological awareness is good.

  2. Change from Electrophysiological at 3 Months

    Time frame: baseline and 3 months

    Mismatch Negativity (MMN) was used to evaluate the central auditory system. Neuron-Spectrum-5 (4/EPM) (Neurosoft, Ivanoco, Russia) was used for the electrophysiological recordings of the study group. Speech stimuli were used as stimuli. Amplitude and latency changes were observed in the Mismatch Negativity test before and after the training. The increase in amplitudes and shortening of latencies after training indicate that the central auditory system has developed.

  3. Change from baseline in the spectral discrimination ability at 3 Months

    Time frame: baseline and 3 months

    Spectral-Temporally Modulated Ripple Test (SMRT) was used to assess the spectral discrimination ability of the study group. The test was performed using SMRT software. Waveform broadband noise with spectral-temporal modulation was used. In each trial, three ripple sounds were presented. Two stimuli were reference signals with an intensity of 20 ripple/octave (rpo) and another stimulus was a target signal with a lower rpo intensity. The initial intensity of the target signal was 0.5 rpo and was replaced by a step size of 0.2 rpo. Adaptive running terminated after ten reverses.Spectral-Temporally Modulated Ripple Test was calculated over the last six reversals. Three runs were completed for each child, and the final threshold was determined by averaging the three runs. Having a low rpo value was an indication of good spectral resolution of the children.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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