The aim of this study is to evaluate the effect of music therapy on increasing speech intelligibility of children with cochlear implant.This study is designed randomly and single blind.Target population included 30 children with hearing loss over 3 years old who are used with cochlear implant at least 5 months and did not have any disabilities other than hearing loss.15 children will participate in the control group.They will benefit from traditional treatment for 4 weeks (2 session in a week).15 more children will be in the intervention group.In addition to traditional treatment،at the same time؛they will also benefit from music therapy of 4 weeks (2 session in a week).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101724561N1
Registration date:2015-10-30, 1394/08/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Masoume Hosseini Beydokhti
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3447 2571
Email address
hosseini.mas@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz University of Medical Sciences Jundishapur
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of traditional therapy accompanied with music therapy on speech intelligibility of children with cochlear implant.
Public title
The effect of music therapy to increase speech intelligibility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least 3 years of chronological age. At least 5 months of cochlear implant. Training after planting in Persian. Lack of information of children with any disability, except for hearing loss. Lack of appropriate speech intelligibility for each of the target words.
Exclusion criteria: create any problems in the child's cochlear implant. Lack of parental involvement.
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of medical sience jondishopur
Street address
daneshgah square
City
Ahwaz
Postal code
61357-15794
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.AJUMS.REC.1394.282
2
Ethics committee
Name of ethics committee
University of medical sience jondishopur
Street address
daneshgah square
City
Ahwaz
Postal code
61357-15794
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.AJUMS.REC.1394.282
Health conditions studied
1
Description of health condition studied
Hearing Loss
ICD-10 code
H90.3
ICD-10 code description
Sensorineural hearing loss, bilateral
Primary outcomes
1
Description
Speech intelligibility of words
Timepoint
A week before intervention - A week after intervention
Method of measurement
Acoustic intelligibility of speech in percent
2
Description
Speech intelligibility of sentences
Timepoint
A week before intervention - A week after intervention
Method of measurement
SIR scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : 4 weeks music therapy ( 2 session of 30 minutes in every week ) and at the same time,4 weeks of traditional treatment about speech intelligibility increasing ( 2 session of 30 minutes in every week) .( Music therapy trainings include of simple musical lyrics which is applied and traditional treatment trainings include of modifying the placement and expression of letters.)
Category
Other
2
Description
Control group : 4 weeks of traditional treatment about speech intelligibility increasing ( 2 session of 30 minutes in every week ).( traditional treatment trainings include of modifying the placement and expression of letters.)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hearing cochlear implant center
Full name of responsible person
Dr.Saki-Nader(Ear.Throat.Nose Specialist)
Street address
Alamolhoda Street - between Naderi and Kafi
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of medical sience jondishapur
Full name of responsible person
Saki Nader
Street address
Education Development Deputie of jondishapur medical sience university
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?