Behavioral Abnormalities in Dysphonic Children

January 30, 2024 updated by: Gerges Wasfy Gerges, Sohag University
we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

inclusion criteria :

  • dysphonic children age 6-12 years

exclusion criteria:

  • age less than 6 years and more than 12 years,
  • hearing impaired,
  • neurological abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
dysphonic children without behavioral abnormalities
Behavioral: voice therapy
sessions of voice therapy
Other: study group
dysphonic children with behavioral abnormalities
Behavioral: voice therapy
sessions of voice therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in child behavior checklist
Time Frame: Baseline (before sessions) and after 3 months of sessions
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
Baseline (before sessions) and after 3 months of sessions
computerized speech lab.
Time Frame: Baseline (before sessions) and after 3 months of sessions
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
Baseline (before sessions) and after 3 months of sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01011747046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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