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Correlation Between (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of Voice in Dysphonic Children

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ClinicalTrials.gov Identifier: NCT03261141
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Asmaa Fathy, Assiut University

Brief Summary:
The aim of this study is to assess the Correlation between The Arabic Pediatric Voice Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of voice of dysphonic children. This is important to provide an efficient therapeutic strategy for these children.

Condition or disease Intervention/treatment
Dysphonia Combination Product: (PV-RQOL),(APA) ,Acoustic analysis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Correlation Between The Arabic Pediatric Voice Related Quality of Life (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of Voice in Dysphonic Children
Anticipated Study Start Date : November 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

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Group/Cohort Intervention/treatment
study group sixty three children
  1. severity and character of dysphonia APA using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
  2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
  3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL).
Combination Product: (PV-RQOL),(APA) ,Acoustic analysis
  1. severity and character of dysphonia (measured by Auditory Perceptual Assessment using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
  2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
  3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL).
control group sixty three children
  1. severity and character of dysphonia (APA using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
  2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
  3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL).
Combination Product: (PV-RQOL),(APA) ,Acoustic analysis
  1. severity and character of dysphonia (measured by Auditory Perceptual Assessment using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
  2. Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
  3. the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL).



Primary Outcome Measures :
  1. All participants' scores of (PV-RQOL) questionnaire will be correlated with scores of auditory perceptual assessment and Acoustic voice analysis. [ Time Frame: baseline ]
    Application of the Arabic Pediatric Voice Related Quality of Life (PV-RQOL): all participants /parents of the participants will be given (PV-RQOL) form that consists of 10 questions divided among 4 subdomains: The social (questions no: 8 and 10), emotional (questions no: 4 and 5) , The physical (questions no: 2 and 3) and the functional (questions no: 1, 6,7 and 9) . Thus the total score can range from 0 to 100 points with higher scores indicating a better quality of life.and Auditory perceptual assessment (APA) of the participant's voice: the domains will be graded on a scale of 0-3, in which 0 is normal and 3 is severe.and Acoustic voice analysis: will be carried out using Kay Elemetrics' Computerized Speech Laboratory. These measures will be obtained by recording the voice of each participant using a microphone positioned ∼10 cm from his/her mouth and the participantswill be asked to phonate a sustained vowel /a/ at comfortable pitch and intensity levels.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

One hundred twenty six (126) children will participate in the study; in 2 groups ,1-study group 63 children they have dysphonia due to functional (non-organic) causes or due to Minimal Associated Pathological Lesions (MAPLs),2-control group 63 children without vocal complaints They will be recruited from the outpatient clinic of Phoniatric Unit, Assiut University Hospital.

Participants (whether their caretakers or themselves) will sign an informed consent of approval to participate in the study after explanation of the study procedures.

Criteria

Inclusion Criteria:

-clinical diagnosis of change of voice due to functional (non-organic) causes or due to Minimal Associated Pathological Lesions (MAPLs).

Exclusion Criteria:

  • Mental Retardation.
  • chronic illnesses affecting their quality of lives.
  • organic voice disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261141


Contacts
Contact: Asmaa Fathy, resident 01149852648 asmaafathy254@yahoo.com
Contact: Eman Sayed, prof.dr 01004082014 eshh2003@aun.edu.eg

Sponsors and Collaborators
Assiut University

Publications:

Responsible Party: Asmaa Fathy, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03261141     History of Changes
Other Study ID Numbers: PV-RQOL in Dysphonic children
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms