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

September 13, 2022 updated by: Büşra Yılanlı, Uskudar University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • İstanbul University-Cerrahpaşa
      • Istanbul, Turkey
        • Uskudar university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group

There are 9 (35,8%) female and 14 (64,2%) male preschool cochlear implant users in the study group.

Children ranging in age from 5 to 7 who also have 5-6 years old language skills.
Other: Music-Integrated Phonological Awareness training program
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.
Diagnostic test: Spectral-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 test: The 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 test: Mismatch Negativity 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°.
Diagnostic test: Early Language Development (TELD-3)
Test of Early Language Development (TELD-3) measured children's receptive and expressive language skills both group for inclusion criteria.
Experimental: Control group

There are 9 (35.8%) female and 14 (64,2%) male preschool children with normal hearing in the control group.

Children ranging in age from 5 to 6 who also have age-appropriate language skills.
Diagnostic test: The 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 test: Early Language Development (TELD-3)
Test of Early Language Development (TELD-3) measured children's receptive and expressive language skills both group for inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 3 months
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.
baseline and 3 months
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.
baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Collaborators

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Büşra Yılanlı, Msc, Uskudar university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Actual)

June 2, 2021

Study Completion (Actual)

July 16, 2021

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 138955

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD available upon reasonable request to the other authors

Study Data/Documents

  1. Study Protocol
  2. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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