Back to resultsBehavioral Abnormalities in Dysphonic Children
Primary Purpose
Dysphonia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
voice therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Dysphonia
Eligibility Criteria
inclusion criteria :
- dysphonic children age 6-12 years
exclusion criteria:
- age less than 6 years and more than 12 years,
- hearing impaired,
- neurological abnormalities.
Sites / Locations
- Sohag University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
control group
study group
Arm Description
dysphonic children without behavioral abnormalities
dysphonic children with behavioral abnormalities
Outcomes
Primary Outcome Measures
change in child behavior checklist
scale assessing behavioral abnormalities of child as anxiety symptoms,depression symptoms,somatic symptoms,social problems,thought problems,attention problems,aggressive behavior and rule breaking behavior through asking parent of the child with minimal score 24 maximal score 100
computerized speech lab.
voice sample will be taken from child including vowels and connecting speech will be analyzed by computerized speech lab to evaluate change in acoustic parameters as jitter,shimmer,fundamental frequency and noise to harmonic ratio
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05264961
Brief Title
Behavioral Abnormalities in Dysphonic Children
Official Title
Behavioral Abnormalities in Dysphonic Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Other
Arm Description
dysphonic children without behavioral abnormalities
Arm Title
study group
Arm Type
Other
Arm Description
dysphonic children with behavioral abnormalities
Intervention Type
Behavioral
Intervention Name(s)
voice therapy
Intervention Description
sessions of voice therapy
Primary Outcome Measure Information:
Title
change in child behavior checklist
Description
scale assessing behavioral abnormalities of child as anxiety symptoms,depression symptoms,somatic symptoms,social problems,thought problems,attention problems,aggressive behavior and rule breaking behavior through asking parent of the child with minimal score 24 maximal score 100
Time Frame
Baseline (before sessions) and after 3 months of sessions
Title
computerized speech lab.
Description
voice sample will be taken from child including vowels and connecting speech will be analyzed by computerized speech lab to evaluate change in acoustic parameters as jitter,shimmer,fundamental frequency and noise to harmonic ratio
Time Frame
Baseline (before sessions) and after 3 months of sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria :
dysphonic children age 6-12 years
exclusion criteria:
age less than 6 years and more than 12 years,
hearing impaired,
neurological abnormalities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gerges wasfy gerges
Phone
01203327746
Ext
02
Email
gerges.wasfy@med.sohag.edu.eg
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gerges wasfy gerges, assitant lecturer
Phone
01011747046
Email
gerges.wasfy@med.sohag.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Behavioral Abnormalities in Dysphonic Children
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