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Status unknownNCT05215301Updated Jan 31, 2022

Assessment of Multidimensional Voice Program (MDVP) Parameters in Workers

An observational study in Voice Disorders, Occupational Problems and Work-related Illness, sponsored by Fakultas Kedokteran Universitas Indonesia. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Fakultas Kedokteran Universitas Indonesia · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Voice Disorders
  • Occupational Problems
  • Work-related Illness

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Keywords

  • Multidimensional Voice Disorder
  • Voice Quality
  • Occupational Voice Users
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In context

Voice Disorders

77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.

This study's planned enrollment of 500 is above the median of 100 across 23 observational studies indexed under Voice Disorders.

Browse Voice Disorders studies →

Lead sponsor

Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • 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

    Diagnostic Test: Multidimensional Voice Program

  • 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)

    Diagnostic Test: Multidimensional Voice Program

Interventions

  • Diagnostic testMultidimensional 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.

    Also known as: Acoustic Phonation Program, Kay Elemetric Corp MDVP 4500

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What researchers measure

Primary outcomes

  1. F0 (Fundamental Frequency)

    Average fundamental frequency for the vocalization measured in Hz

    Time frame: 3 minutes minimal

  2. Jitter

    Jitter refers to a disruption in sound wave frequencies caused by a lack of control over the vibrations of the vocal cords.

    Time frame: 3 minutes minimal

  3. 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

    Time frame: 3 minutes minimal

  4. 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

    Time frame: 3 minutes minimal

  5. 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.

    Time frame: 3 minutes minimal

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 15387083 ↗
  • 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. PubMed 6415594 ↗
  • 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. PubMed 17922287 ↗

Individual participant data

Plan to share: No — Individual Participant Data will be kept in Cipto Mangunkusumo General Hospital and will only be shared upon official request to the hospital.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05215301
Lead sponsor
Fakultas Kedokteran Universitas Indonesia
Responsible party
Sponsor
First posted
Jan 31, 2022
Start date
Feb 1, 2022 (estimated)
Primary completion
May 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Jan 31, 2022

Study contacts

Mikhael Yosia, MD
Contact
mikhael.yosia@gmail.com
081378778784
Mikhael Yosia, MD
principal investigator · Department of Community Medicine, Faculty of Medicine Universitas Indonesia
Dewi S Soemarko, MD
study chair · Department of Community Medicine, Faculty of Medicine Universitas Indonesia
Marsen Isbayuputra, MD
study chair · Department of Community Medicine, Faculty of Medicine Universitas Indonesia
Syahrial M Hutauruk, MD
study chair · Department of ORL-HNS, Faculty of Medicine Universitas Indonesia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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