Assessment of Multidimensional Voice Program (MDVP) Parameters in Workers

Voice Disorders Clinical Trial

Official title:

Assessment of Multidimensional Voice Program (MDVP) Parameters in Occupational and Non-occupational Voice Users: a Secondary Data Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05215301
• Other study ID #: THT003
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2022
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Mikhael Yosia, MD
• Phone: 081378778784
• Email: mikhael.yosia[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

MDVP (Multidimensional Voice Program) has several parameters that can assess voice quality objectively, including Base Frequency (F0), Jitter, Shimmer, NHR (Noise to Harmonic Ratio), VTI (Voice Turbulence Index), and ATRI (Amplitude Tremor Intensity Index). MDVP may provide an objective yet non-invasive and comfortable alternative to assess voice quality - and to some extent, diagnose voice-related abnormalities. The utilization of MDVP in clinical settings is quite common but using it concerning occupational health is rare, especially in Indonesia. No study had reported usage of MDVP to assess voice quality in any occupational voice user group or reported a thorough comparison of MDVP parameters between occupational and non-occupational voice users. With an increase in the realization that voice can be an essential occupational modality, MDVP may become a practical alternative modality in assessing voice quality and occupational-related voice injury in clinical settings. This study will determine any association between occupational voice users and their MDVP parameters from medical records and the MDVP database in Dr Cipto Mangunkusumo Hospital, Jakarta. The study also tries to see whether there is any value in using MDVP to assess voice quality in workers.

Description:

Data will be extracted from the MDVP database and hospital medical records. The MDVP database consists of patients examined with MDVP in the Department of ORL-HNS' Larynx-Pharynx clinic of Dr. Cipto Mangunkusumo Hospital, Jakarta. Voice evaluation for all patients in Dr. Cipto Mangunkusuomo Hospital was done using the Multidimensional Voice Program (MDVP) 4500 produced by Kay Elemetrics Corp installed on a personal computer. The patients were asked to emit vocal sounds /" a "/ using the tone and intensity of everyday speech. The physicians are obliged to give an example first. The patient's voice was then recorded using a microphone connected to a computer with the MDVP program. Sounds were recorded in a quiet room for at least 3 seconds with the microphone 10 cm from the patient's mouth. The MDVP program will directly analyze the recorded sound. Sound recording is done 3 - 5 times, and the best sound acoustic analysis results are used as the final result. The results are then kept in the program's database inside the computer. Patients who attend the Larynx-Pharynx clinic for MDVP evaluations are usually those who comes for post-treatment monitoring (e.g., post-laryngoplasty), had been diagnosed with a voice disorders, and or by personal or physicians' request. There are various reasons why patients are being assigned to MDVP evaluations - and all of this information will be gathered and used as a consideration during data analysis. For the sake of practicality, the researcher will only extract MDVP data from the past five years. Other considerations will be made to ensure that the data extracted will represent a reliable comparison between occupation status and how it affects MDVP parameters (see more in "Criteria for subjects"). The study will use total sampling, where all available data that fits the inclusion criteria will be used for analysis. Inclusion criteria - Patients had their medical records and MDVP data available in dr. Cipto Mangunkusumo Hospital, Jakarta - Patients are active workers in Indonesia on the time of MDVP evaluation - Patients are above the age of 18 - Patients can be either an occupational or non-occupational voice users Exclusion criteria - Patients with incomplete occupational data - Patient with incomplete MDVP results Data obtained from the database will be evaluated in SPSS v20 software and analysed to produce descriptive and inferential statistics. The inferential statistics will consist of univariate analysis and bivariate analysis (between two variables). All numeric data will be tested for normal distribution using Kolmogorov-Smirnov. Univariate analysis will be done to see the average, distribution, and frequency of all variables/outcomes which include the participants' demographic information and MDVP parameters. MDVP parameters will be presented as mean score with its standard deviation (or median with range). Bivariate analysis will be done to evaluate the significance between occupational or non-occupational users to their MDVP parameters. Differences between groups will be assessed using independent samples t-test (parametric) or Mann-Whitney (non-parametric). If possible, multivariate analysis will also be conducted using Chi-Square or Fischer test depending on the data distributions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients had their medical records and MDVP data available in dr. Cipto Mangunkusumo Hospital, Jakarta
• Patients are active workers in Indonesia on the time of MDVP evaluation
• Patients are above the age of 18
• Patients can be either an occupational or non-occupational voice users

Exclusion Criteria:

• Patients with incomplete occupational data
• Patient with incomplete MDVP results

Related Conditions & MeSH terms

• Occupational Problems
• Voice Disorders

Intervention

Diagnostic Test:
• Multidimensional Voice Program
MDVP (Multidimensional Voice Program) is a computerized acoustic analysis used to analyze sound quality using various parameters. Multidimensional Voice Program (MDVP) 4500 produced by Kay Elemetric Corp was used for voice evaluation. Research subjects were asked to make a vowel sound /"a"/ using the same tone and intensity as the subject's daily speech. The researcher will give an example before letting the research subject tries. Voice recording was done using a microphone connected to a computer with the MDVP program. Voice recording was done in a quiet room for at least 3 seconds with a microphone distance of 10 cm from the mouth of the research subject. The recorded sound will be directly analyzed with the MDVP program. Sound recording was done 3 - 5 times, and the best sound acoustic analysis results were used for the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

References & Publications (3)

Feder RJ. Varix of the vocal cord in the professional voice user. Otolaryngol Head Neck Surg. 1983 Aug;91(4):435-6. — View Citation

Godino-Llorente JI, Osma-Ruiz V, Sáenz-Lechón N, Cobeta-Marco I, González-Herranz R, Ramírez-Calvo C. Acoustic analysis of voice using WPCVox: a comparative study with Multi Dimensional Voice Program. Eur Arch Otorhinolaryngol. 2008 Apr;265(4):465-76. Epu — View Citation

Kosztyla-Hojna B, Rogowski M, Ruczaj J, Pepinski W, Lobaczuk-Sitnik A. An analysis of occupational dysphonia diagnosed in the North-East of Poland. Int J Occup Med Environ Health. 2004;17(2):273-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F0 (Fundamental Frequency)	Average fundamental frequency for the vocalization measured in Hz	3 minutes minimal
Primary	Jitter	Jitter refers to a disruption in sound wave frequencies caused by a lack of control over the vibrations of the vocal cords.	3 minutes minimal
Primary	Shimmer	Shimmer percent gives an evaluation in percent of the variability of the peak-to-peak amplitude within the analyzed voice samples. It represents the relative period-to-period (very short-term) variability of the peak-to-peak amplitude	3 minutes minimal
Primary	NHR (Noise to Harmonic Ratio)	Noise-to-harmonic ratio is an average ratio of energy of the in-harmonic components in the range 1500-4500 Hz to the harmonic components energy in the rage 70-4500 Hz. It is a general evaluation of the noise present in the vocalization	3 minutes minimal
Primary	ATRI (Amplitude Tremor Intensity Index)	Amplitude tremor intensity index shows (in percent) the ratio of the amplitude of the most intensive low-frequency amplitude-modulating component (amplitude tremor) to the total amplitude of the analyzed voice signal.	3 minutes minimal