Comparison the immediate effect of straw phonation on the acoustic and glottal performance in two group of Persian-speaking children with cleft palate and normal.
Comparison of the immediate effect of phonation with a straw on the acoustic characteristics and glottal performance in normal Persian-speaking children and with cleft palate.
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 assessment (acoustic and electroglottography) will be done, then in the second stage, vocal training with a free end of straw in air will be done for three minutes, and then the assessments that were done in the basic stage will be repeated.
Participants/Inclusion and exclusion criteria
Existence of compensatory production error and velopharyngeal insufficiency (VPI) in cleft palate group.
Similarity of people in the normal group in terms of gender and age with people in the cleft palate group.
Intervention groups
group with Cleft palate people.
group with normal people.
Main outcome variables
jitter؛ shimmer؛ first formant؛ second formant؛ third formant؛ bandwidth of first formant؛ bandwidth of second formant؛ contact quotient؛ cepstral peak prominence (CPP)؛ harmonic to noise ratio (HNR)؛ fundamental frequency؛ maximum phonation time
General information
Reason for update
Acronym
SOVTE
IRCT registration information
IRCT registration number:IRCT20230403057804N1
Registration date:2023-04-15, 1402/01/26
Registration timing:registered_while_recruiting
Last update:2023-04-15, 1402/01/26
Update count:0
Registration date
2023-04-15, 1402/01/26
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
2023-04-09, 1402/01/20
Expected recruitment end date
2023-05-26, 1402/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the immediate effect of straw phonation on the acoustic and glottal performance in two group of Persian-speaking children with cleft palate and normal.
Public title
Comparison of the effect of artificially increasing the length of the vocal tube on voice and vocal fold vibration in people with cleft palate and normal people.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a compensatory production error (group of people with cleft palate).
have velopharyngeal insufficiency due to cleft palate (group of people with cleft palate).
Have healthy bilateral hearing (group of normal people and with cleft palate).
Do not have a disease that causes voice disorders (group of people with cleft palate).
Do not have other speech therapy in the field of voice therapy and correction of compensatory errors at the same time as studying (group of people with cleft palate).
They do not have cleft palate syndrome, fistula, cold, upper respiratory tract infection, and neurological, cognitive, and motor speech control problems (group of normal people and with cleft palate).
Children aged 6 to 12 years with Persian-speaking (group of normal people and with cleft palate).
Exclusion criteria:
Failure to record data or unanalyzable data.
A person's inability to do tasks 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:
34
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
2023-04-06, 1402/01/17
Ethics committee reference number
IR.UMSHA.REC.1401.895
Health conditions studied
1
Description of health condition studied
The effect of semi-occluded vocal tract on acoustic characteristics and glottal performance in cleft palate and normal subjects.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fundamental frequency
Timepoint
Immediately before and after the intervention
Method of measurement
PRAAT software
Secondary outcomes
1
Description
fundamental frequency
Timepoint
Immediately before and after the intervention
Method of measurement
PRAAT software
2
Description
Contact Quotient
Timepoint
Immediately before and after the intervention
Method of measurement
Electroglottography device
Intervention groups
1
Description
Intervention group: children with cleft palate
Category
Prevention
2
Description
Control group: normal children
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Speech Therapy Clinics in Hamadan University of M
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
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 updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
seyede saghar hashemnia
Position
Master of Science student
Latest degree
Bachelor
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