Clinical trial NCT03261141: Correlation Between (PV-RQOL), The Auditory Perceptual Assessment and Acoustic Analysis of Voice in Dysphonic Children
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysphonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 126
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: All participants' scores of (PV-RQOL) questionnaire will be correlated with scores of auditory perceptual assessment and Acoustic voice analysis.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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