NCT02102399

Brief Summary

The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and the hypothesis is that both approaches can produce positive voice changes, but the Vocal Warm-up will produce the most significant changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 17, 2015

Completed
Last Updated

October 8, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

March 30, 2014

Results QC Date

January 24, 2015

Last Update Submit

September 23, 2015

Conditions

Keywords

Voice trainingEducationVoiceFaculty

Outcome Measures

Primary Outcomes (18)

  • Voice Handicap Index (VHI-10)

    The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values \> 11.

    Baseline, 6 weeks

  • Acoustic Analysis (Fundamental Frequency)

    The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.

    Baseline, 6 weeks

  • Acoustic Analysis (Jitter)

    Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be \< 0.6%.

    Baseline, 6 weeks

  • Acoustic Analysis (Shimmer)

    The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values \< 6.5%.

    Baseline, 6 weeks

  • Acoustic Analysis (Noise)

    Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels \< 2.5 dB

    Baseline, 6 weeks

  • Acoustic Analysis (GNE)

    Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels \> 0.5 dB

    Baseline, 6 weeks

  • Voice Handicap Index (VHI-10) 2

    The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values \> 11.

    Baseline, 6 weeks

  • Acoustic Analysis (Fundamental Frequency) 2

    The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.

    Baseline, 6 weeks

  • Acoustic Analysis (Jitter) 2

    Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be \< 0.6%.

    Baseline, 6 weeks

  • Acoustic Analysis (Shimmer) 2

    The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values \< 6.5%.

    Baseline, 6 weeks

  • Acoustic Analysis (Noise) 2

    Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels \< 2.5 dB

    Baseline, 6 weeks

  • Acoustic Analysis (GNE) 2

    Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels \> 0.5 dB

    Baseline, 6 weeks

  • Change in Voice Handicap Index (VHI-10)

    The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values \> 11.

    Baseline, 6 weeks

  • Change in Fundamental Frequency

    The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.

    Baseline, 6 weeks

  • Change in Jitter

    Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be \< 0.6%.

    Baseline, 6 weeks

  • Change in Shimmer

    Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values \< 6.5%

    Baseline, 6 weeks

  • Change in Noise

    Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels \< 2.5 dB

    Baseline, 6 weeks

  • Change in GNE

    Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels \> 0.5 dB

    Baseline, 6 weeks

Secondary Outcomes (4)

  • Post-treatment Questionnaire (Voice Symptoms Improvement)

    After 6 weeks of intervention

  • Post-treatment Questionnaire (Voice Clearer)

    After 6 weeks of intervention

  • Post-treatment Questionnaire (Easier to Talk)

    After 6 weeks of intervention

  • Post-treatment Questionnaire (Compliance With Intervention)

    After 6 weeks of intervention

Study Arms (2)

Vocal Warm-up

EXPERIMENTAL

Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.

Behavioral: Vocal Warm-up

Respiratory Muscle Training

EXPERIMENTAL

Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.

Behavioral: Respiratory Muscle Training

Interventions

Vocal Warm-upBEHAVIORAL

Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.

Vocal Warm-up

Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.

Respiratory Muscle Training

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-60.
  • No occurence of speech therapy simultaneously to the intervention

You may not qualify if:

  • Professional voice use in another activity;
  • Frequent use of alcohol and tobacco;
  • Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Bahia

Salvador, Estado de Bahia, 40.026-010, Brazil

Location

Related Publications (1)

  • Pereira LP, Masson ML, Carvalho FM. Vocal warm-up and breathing training for teachers: randomized clinical trial. Rev Saude Publica. 2015;49:67. doi: 10.1590/S0034-8910.2015049005716. Epub 2015 Oct 9.

MeSH Terms

Conditions

Voice Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Limitations and Caveats

Small and not probabilistic sample; type I error; type II error; strike in the last week of the study; healthy worker effect.

Results Point of Contact

Title
Lilian Paternostro
Organization
Federal University of Bahia

Study Officials

  • Maria Lucia V Masson, PhD

    Federal University of Bahia

    PRINCIPAL INVESTIGATOR
  • Lilian Paternostro, MS

    Federal University of Bahia

    STUDY CHAIR
  • Fernando M Carvalho, PhD

    Federal University of Bahia

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maria Lucia Vaz Masson

Study Record Dates

First Submitted

March 30, 2014

First Posted

April 2, 2014

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 8, 2015

Results First Posted

September 17, 2015

Record last verified: 2015-09

Locations