Comparison of changes in voice acoustic characteristics and glottal performance after artificially increasing vocal tube length and adding a secondary vibration source in children with and without Persian-speaking cleft palate and normal Persian-speaking children.
Investigating the immediate effect of phonation with a free-end straw and straw-end immersed in water in two groups of normal and cleft palate children and investigating the effects of each treatment in inter-group and intra-group comparisons, as well as investigating the effects of treatments in intra-group and inter-group comparisons. To determine which of these two types of treatment is more effective for this population to prevent voice disorders.
Design
A semi-experimental intervention pre and post intervention
Settings and conduct
The performance will be performed in the acoustic room of the Speech Therapy Department of Hamedan Rehabilitation Faculty. In the first stage of implementation; The basic evaluation (acoustic and electroglottography) will be done, then in the second stage, vocal training with a free end straw will be done for three minutes. After 20 minutes of vocal rest, the vocal exercise is done with a straw in the water. All stages of implementation are the same in both natural and cleft palate groups.
Participants/Inclusion and exclusion criteria
Two groups of 6-12-year-old Persian-speaking children with cleft palate and normal.
Intervention groups
First, initial assessments are conducted, then the first vocal exercise is presented (including vocalization on the straw with free end in air), then the initial assessments are repeated again, and after a twenty-minute vocal rest, the second vocal exercise is presented (which includes vocalization on the straw with free end in water), and then the assessments are repeated again.
Main outcome variables
jitter؛ shimmer؛ contact quotient؛ cepstral peak prominence (CPP)؛ harmonic to noise ratio (HNR)؛ fundamental frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230403057804N5
Registration date:2025-01-18, 1403/10/29
Registration timing:retrospective
Last update:2025-01-18, 1403/10/29
Update count:0
Registration date
2025-01-18, 1403/10/29
Registrant information
Name
Kowsar Baghban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
baghban.kowsar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-09, 1403/08/19
Expected recruitment end date
2025-01-08, 1403/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of changes in voice acoustic characteristics and glottal performance after artificially increasing vocal tube length and adding a secondary vibration source in children with and without Persian-speaking cleft palate and normal Persian-speaking children.
Public title
Comparison of changes in voice acoustic characteristics and glottal performance after artificially increasing vocal tube length and adding a secondary vibration source in children with and without Persian-speaking cleft palate and normal Persian-speaking children.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have healthy bilateral hearing.
Do not have other speech therapy in the field of voice therapy and correction of compensatory errors at the same time as studying.
Exclusion criteria:
A person's inability to do homework despite the therapist's training and modeling.
The unwillingness of the child and the family to cooperate until the end of the study.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
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
Ethics committee of Hamadan university of medical science
Street address
5th floor, headquarters of the University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2024-11-08, 1403/08/18
Ethics committee reference number
R.UMSHA.REC.1403.584
Health conditions studied
1
Description of health condition studied
Study of changes and comparison of results of two acoustic interventions on acoustic characteristics and vocal cord vibration in children with cleft palate
ICD-10 code
Q35
ICD-10 code description
Cleft lip and cleft palate
Primary outcomes
1
Description
Jitter
Timepoint
Immediately before and after the intervention
Method of measurement
PRAAT software
Secondary outcomes
1
Description
Contact Quotient
Timepoint
Immediately before and after the intervention
Method of measurement
Electroglottography device
2
Description
Shimmer
Timepoint
Immediately before and after the intervention
Method of measurement
PRAAT software
3
Description
Harmonic to noise ratio
Timepoint
Immediately before and after the intervention
Method of measurement
PRAAT software
4
Description
Cepstral peak prominence
Timepoint
Immediately before and after the intervention
Method of measurement
PRAAT software
Intervention groups
1
Description
First, acoustic and electroglottographic evaluations are performed in both groups, and then the first vocal exercise, which involves vocalizing the vowel /u/ for three minutes in a straw with free end in air, is presented. Then, acoustic and electroglottographic evaluations are performed again. Then, a twenty-minute vocal rest is given, and the second vocal exercise is presented. After vocal rest, a second vocal exercise, which involves vocalizing the vowel /u/ for three minutes in a straw with free end in water, is presented, and then the acoustic and electroglottographic assessments are repeated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Speech Therapy Clinics in Hamadan University of Medical Science
Full name of responsible person
Kowsar Baghban
Street address
Shahid fahmide Blv
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 1571
Email
baghban.kowsar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokoohi
Street address
5th floor, headquarters of the University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Kowsar Baghban
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, Faculty of Rehabilitation, University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1571
Email
baghban.kowsar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Kowsar Baghban
Position
Assistant professor of Department of Speech Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Shahid Fahmideh Blvd,Pajoohesh Squa
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1571
Fax
Email
baghban.kowsar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
seyede saghar hashemnia
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Speech therapy department, Faculty of Rehabilitation, University of Medical Sciences, Shahid Fahmideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1572
Email
hashemniasaghar1401@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available