- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05215301
Assessment of Multidimensional Voice Program (MDVP) Parameters in Workers
Assessment of Multidimensional Voice Program (MDVP) Parameters in Occupational and Non-occupational Voice Users: a Secondary Data Analysis
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mikhael Yosia, MD
- Phone Number: 081378778784
- Email: mikhael.yosia@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Occupational Voice Users
Workers who uses voice extensively during work falls under occupational voice users (e.g.
singers, actors, radio announcer, teacher, translator, lawyer).
The grouping were made based on references from The Union of the European Phoniatricians
|
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.
Other Names:
|
|
Non-occupational Voice Users
Those who didn't use voice extensively during work falls under non-occupational voice users (motorcycle drivers, daily labor, administrative workers)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
F0 (Fundamental Frequency)
Time Frame: 3 minutes minimal
|
Average fundamental frequency for the vocalization measured in Hz
|
3 minutes minimal
|
|
Jitter
Time Frame: 3 minutes minimal
|
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
|
|
Shimmer
Time Frame: 3 minutes minimal
|
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
|
|
NHR (Noise to Harmonic Ratio)
Time Frame: 3 minutes minimal
|
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
|
|
ATRI (Amplitude Tremor Intensity Index)
Time Frame: 3 minutes minimal
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mikhael Yosia, MD, Department of Community Medicine, Faculty of Medicine Universitas Indonesia
- Study Chair: Dewi S Soemarko, MD, Department of Community Medicine, Faculty of Medicine Universitas Indonesia
- Study Chair: Marsen Isbayuputra, MD, Department of Community Medicine, Faculty of Medicine Universitas Indonesia
- Study Chair: Syahrial M Hutauruk, MD, Department of ORL-HNS, Faculty of Medicine Universitas Indonesia
Publications and helpful links
General Publications
- 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.
- Feder RJ. Varix of the vocal cord in the professional voice user. Otolaryngol Head Neck Surg. 1983 Aug;91(4):435-6. doi: 10.1177/019459988309100417.
- Godino-Llorente JI, Osma-Ruiz V, Saenz-Lechon N, Cobeta-Marco I, Gonzalez-Herranz R, Ramirez-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. doi: 10.1007/s00405-007-0467-x. Epub 2007 Oct 9.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THT003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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