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

October 23, 2017 updated by: Asmaa Fathy, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Voice is the carrier wave for speech signal. It can also be defined as an audible sound produced by phonation . It is a primary mean of expression and oral communication and has life-long importance to social well-being.

Through life, voice development follows and represents organic, psychological, and social changes in the person .

Any disruption of the function of voice is called dysphonia . defination of dysphonia is perceptual audible change of a patient's habitual voice as self-judged or judged by his or her listeners.

The incidence of the pediatric voice disorders ranges from 6%-23%, while, stated that voice disorders affect approximately 6-9% of pediatric population. Boys were statistically more likely to have dysphonia (7.5%) over girls (4.6%) , abnormal vocal presentations (symptomatology) include: phonasthenia ,dysphonia, aphonia and dysodia. Dysphonia may adversely impact a child's general health, communicative effectiveness, social and educational development, self-esteem, and participation in school group activities. Hence, dysphonia has a substantial negative effect on children's lives.Although voice disorders are common in the pediatric population; there is still a lack of information available to clinicians regarding evaluation and treatment of pediatric voice disorders.

Etiology of Voice disorders can be subdivided into 3 main groups: There are the organic voice disorders (There are detectable morphological changes in the vocal apparatus), Non-organic (functional) voice disorders (There is no detectable organic pathology in the structure of the larynx) and Minimal Associated Pathological Lesions (MAPLs) (Long-standing, non-organic (functional) voice disorders leading to the creation of detectable organic changes.

The protocol of evaluation of voice disorders is constructed /built in escalating stepwise stages from the simple subjective bed-side diagnostic procedures to the more sophisticated objective quantitative instrumental measures. Thus the protocol encompasses the following 3 levels which are 1- Elementary diagnostic procedures, 2-Clinical diagnostic aids 3-Additional instrumental measures .

Several instruments have been designed specifically to evaluate quality of life outcomes in dysphonic populations. The best validated and most utilized surveys are the Voice Handicap Index (VHI) , the Voice Outcome Survey (VOS) and the Voice-Related Quality of Life (V-RQoL) . These instruments were designed to be used in the assessment of dysphonic patients and were validated in adult populations. Since their dissemination, each of these instruments have produced a pediatric analogue, namely a pediatric VOS (PVOS) , a pediatric V-RQoL and a pediatric VHI (PVHI).

Questionnaire may help to increase the patient's awareness of the impact of dysphonia and his motivation for change. The Questionnaires have also been proven sensitive to post-changes and are an additional and valuable tool in the determination of therapy efficiency.

At Minia University, a study was carried out to develop an Arabic version of PVRQoL and test its validity and reliability .The results suggested that the APVRQoL is a valid and reliable assessment tool that can be used by the parents of Arabic-speaking children or by the children themselves (when they are older) with voice disorders to assess the impact of dysphonia on the quality of their lives.

The (PV-RQOL) has 10 questions that are 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), each question is rated from 1to5 (1=no problem and is given"10 points",2=a small amount and is given"7.5points",3=a moderate amount and is given"5 points",4=a lot and is given"2.5 points", and 5=problem is as bad as it can be, and is given"0 points". Thus the raw scores can range from 0 to 100 points with higher scores indicating a better quality of life.

Study Type

Observational

Enrollment (Anticipated)

126

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 Contact Backup

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

4 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV-RQOL in Dysphonic children

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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