Evaluation of the efficacy and efficiency of phonemic training programs in auditory processing status of prelingually deaf children with Cochlear implant: a single subject study
Reviewing the hearing difficulties due to susceptible auditory processing deficits in cochlear implant users and evaluating the efficacy of Phonemic training program and Phonemic Synthesis Program on these users based on single-subject study design
Design
A single arm pre- post test
Settings and conduct
A single-arm trial on 7-year-old patients referred to the Tabassom Clinic, Ahvaz, Iran for cochlear implant
Participants/Inclusion and exclusion criteria
Inclusion criteria
- Healthy peripheral auditory system
- Healthy hearing system
- Normal IQ based on Wechsler Intelligence Test
- No history of chronic otitis media
- Right hand based on the Edinburgh Handwriting Questionnaire
- Farsi-language monolingual
Exclusion criteria
- Non-participation in evaluation sessions
- Individual or parent's unwillingness to participate in research
- Middle ear infection between test and retest
- Fatigue, reduction or lack of attention
Intervention groups
The intervention phase includes two training programs: The phonemic Synthesis Program and the Phonemic Training Program.
Considering the nature of the study, no control group is needed.
Main outcome variables
The status of Word recognition score; The status of Phoneme recognition score in PRT; The status of Quantitative score in PST; The status of Qualitative score in PST; The status of Buffalo model subcategories including decoding, tolerance fading memory, and organization; The status of the pattern of phoneme errors including omission, substitution, added, and total phoneme errors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200120046209N1
Registration date:2020-04-14, 1399/01/26
Registration timing:registered_while_recruiting
Last update:2020-04-14, 1399/01/26
Update count:0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Sahar Shomeil Shushtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3750 5694
Email address
sshomeil@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and efficiency of phonemic training programs in auditory processing status of prelingually deaf children with Cochlear implant: a single subject study
Public title
Evaluating the efficacy of phonemic training in cochlear implant users
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy peripheral auditory system
Healthy hearing system
Normal IQ based on Wechsler Intelligence Test
No history of chronic otitis media
Right hand based on the Edinburgh Handwriting Questionnaire
Persian-language monolingual
Exclusion criteria:
Non-participation in evaluation sessions
Individual or parent's unwillingness to participate in research
Middle ear infection between test and retest
Fatigue, reduction or lack of attention
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Joint Organizational Ethics Committee of Faculty of Nursing and Midwifery with Faculty of Rehabilita
Street address
Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
61537
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.TUMS.FNM.REC.1398.140
Health conditions studied
1
Description of health condition studied
Children with hearing loss
ICD-10 code
H91.90
ICD-10 code description
Unspecified hearing loss, unspecified ear
Primary outcomes
1
Description
Phoneme recognition test: It is a test specifically designed to evaluate phonological level auditory processing ability in cochlear implant users.
Timepoint
The score is a percentage obtained through testing and observation. The test will be conducted eight weeks before the intervention phase, during the intervention phase once time every week, once a week after the intervention phase for eight-week.
Method of measurement
Phoneme recognition score based on PRT, Quantitative score based on PST, Qualitative score based on PST, Qualifiers representing buffalo model subcategories based on PST, Speech discrimination score based on WRS, Patterns, and frequency of phoneme errors including omission, substitution, added and total based on PEA
Secondary outcomes
1
Description
Phoneme synthesis Test: Presenting a phoneme to a phoneme is a meaningful (or nonsensical) word in which the listener is obliged to stick these phonemes together and to express the word forming it.
Timepoint
The raw data points are obtained through testing and observation. This test will be performed before the intervention once a week for eight weeks, during the intervention once a week for eight weeks and after the intervention once a week for eight weeks.
Method of measurement
The 54 words in the one-to-four syllable that are referred to as full-color images form the test items. The general requirements for word assignment are frequency testing, high imaging capability and specific item allocation conditions are consistent with the test objectives. Among the vocabulary assigned to this test are 31 single syllables, 18 binary syllables, three syllables, and one quadratic syllable, and 29 end-of-sentence words.
Intervention groups
1
Description
Intervention group: Persian-speaking children 8-11 years old with cochlear implant
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabasam Comprehensive Hearing and Speech Rehabilitation Center