NCT05264961

Brief Summary

we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

February 8, 2022

Last Update Submit

January 30, 2024

Conditions

Dysphonia

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline (before sessions) and after 3 months of sessions

  • 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

    Baseline (before sessions) and after 3 months of sessions

Study Arms (2)

control group

OTHER

dysphonic children without behavioral abnormalities

Behavioral: voice therapy

study group

OTHER

dysphonic children with behavioral abnormalities

Behavioral: voice therapy

Interventions

voice therapyBEHAVIORAL

sessions of voice therapy

control groupstudy group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • dysphonic children age 6-12 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 8, 2022

First Posted

March 3, 2022

Study Start

March 1, 2022

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

EG(1)