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

Dysphonia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03261141
• Other study ID #: PV-RQOL in Dysphonic children
• Status: Not yet recruiting
• Phase: N/A
• First received: August 21, 2017
• Last updated: October 23, 2017
• Start date: November 1, 2017
• Est. completion date: October 2018

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Asmaa Fathy, resident
• Phone: 01149852648
• Email: asmaafathy254[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysphonia

Intervention

Combination Product:
• (PV-RQOL),(APA) ,Acoustic analysis
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. 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). 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (11)

Blumin JH, Keppel KL, Braun NM, Kerschner JE, Merati AL. The impact of gender and age on voice related quality of life in children: normative data. Int J Pediatr Otorhinolaryngol. 2008 Feb;72(2):229-34. Epub 2007 Dec 11. — View Citation

Boseley ME, Cunningham MJ, Volk MS, Hartnick CJ. Validation of the Pediatric Voice-Related Quality-of-Life survey. Arch Otolaryngol Head Neck Surg. 2006 Jul;132(7):717-20. — View Citation

Carding PN, Roulstone S, Northstone K; ALSPAC Study Team. The prevalence of childhood dysphonia: a cross-sectional study. J Voice. 2006 Dec;20(4):623-30. Epub 2005 Dec 19. — View Citation

Connor NP, Cohen SB, Theis SM, Thibeault SL, Heatley DG, Bless DM. Attitudes of children with dysphonia. J Voice. 2008 Mar;22(2):197-209. Epub 2007 May 18. — View Citation

Gliklich RE, Glovsky RM, Montgomery WW. Validation of a voice outcome survey for unilateral vocal cord paralysis. Otolaryngol Head Neck Surg. 1999 Feb;120(2):153-8. — View Citation

Hartnick CJ. Validation of a pediatric voice quality-of-life instrument: the pediatric voice outcome survey. Arch Otolaryngol Head Neck Surg. 2002 Aug;128(8):919-22. — View Citation

Kotby MN, Shiromoto O, Hirano M. The accent method of voice therapy: effect of accentuations on FO, SPL, and airflow. J Voice. 1993 Dec;7(4):319-25. — View Citation

Lopes LW, Barbosa Lima IL, Alves Almeida LN, Cavalcante DP, de Almeida AA. Severity of voice disorders in children: correlations between perceptual and acoustic data. J Voice. 2012 Nov;26(6):819.e7-12. doi: 10.1016/j.jvoice.2012.05.008. — View Citation

Trani M, Ghidini A, Bergamini G, Presutti L. Voice therapy in pediatric functional dysphonia: a prospective study. Int J Pediatr Otorhinolaryngol. 2007 Mar;71(3):379-84. Epub 2006 Nov 29. — View Citation

Verduyckt I, Remacle M, Jamart J, Benderitter C, Morsomme D. Voice-related complaints in the pediatric population. J Voice. 2011 May;25(3):373-80. doi: 10.1016/j.jvoice.2009.11.008. Epub 2010 Apr 1. — View Citation

Zur KB, Cotton S, Kelchner L, Baker S, Weinrich B, Lee L. Pediatric Voice Handicap Index (pVHI): a new tool for evaluating pediatric dysphonia. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):77-82. Epub 2006 Oct 13. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All participants' scores of (PV-RQOL) questionnaire will be correlated with scores of auditory perceptual assessment and Acoustic voice analysis.	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