NCT03261141

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

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

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 24, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

August 21, 2017

Last Update Submit

October 23, 2017

Conditions

Dysphonia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

(PV-RQOL),(APA) ,Acoustic analysisCOMBINATION_PRODUCT

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 childrenstudy group sixty three children

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 23177753BACKGROUND

  • 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. doi: 10.1016/s0892-1997(05)80120-1.

    PMID: 8293064BACKGROUND

  • 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. doi: 10.1016/j.jvoice.2005.07.004. Epub 2005 Dec 19.

    PMID: 16360302BACKGROUND

  • 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. doi: 10.1016/j.ijporl.2006.11.002. Epub 2006 Nov 29.

    PMID: 17137639BACKGROUND

  • 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. doi: 10.1016/j.ijporl.2007.10.015. Epub 2007 Dec 11.

    PMID: 18063123BACKGROUND

  • 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. doi: 10.1016/j.jvoice.2006.09.005. Epub 2007 May 18.

    PMID: 17512168BACKGROUND

  • 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. doi: 10.1016/S0194-5998(99)70399-2.

    PMID: 9949345BACKGROUND

  • 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. doi: 10.1001/archotol.128.8.919.

    PMID: 12162771BACKGROUND

  • 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. doi: 10.1001/archotol.132.7.717.

    PMID: 16847178BACKGROUND

  • 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. doi: 10.1016/j.ijporl.2006.09.004. Epub 2006 Oct 13.

    PMID: 17046072BACKGROUND

  • 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.

    PMID: 20359863BACKGROUND

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Asmaa Fathy, resident

CONTACT

01149852648asmaafathy254@yahoo.com

Eman Sayed, prof.dr

CONTACT

01004082014eshh2003@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 24, 2017

Study Start

November 1, 2017

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

October 24, 2017

Record last verified: 2017-08