Voice DisordersNCT01196611
Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
A study testing Voice Amplification and Function Voice Exercises in people with Voice Disorders, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The study compares two different approaches of voice therapy. Vocal Functional Exercises (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II - Tecnisystem do Brasil TSI 1210). Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Voice Disorders
- What is being tested?
- Voice Amplification and Function Voice Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female teacher
- 21-50 years old.
- Full or part time elementary to middle school teacher ( Prefeitura Municipal de Belo Horizonte).
- Minimum 20 hour weekly workload.
- Medical reference to speech therapy due to behavioral dysphonia
Who cannot join
- Physical education or daycare teachers.
- Professional singers.
- Neurological and/or psychiatric voice disorders
Trial locations and contacts
1 site in 1 country.
About this study
The study compares two different approaches of voice therapy. Vocal Functional Exercises (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II - Tecnisystem do Brasil TSI 1210).
Read the detailed description
Both approaches combined with Vocal Hygiene Program (Behlau, 2007).The target population are female teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Vocal Functional Exercises and Voice Amplification are equally effective at improving vocal functioning in teachers with voice disorders. The Fiberoptic endoscopic evaluation will be done before randomization. All the participants will complete before and after a 6-week treatment phase (a) Voice Activity and Participation Profile (PPAV), an instrument designed to appraise the self-perceived psychosocial consequences of voice disorders to assess the impact of voice disorders on daily activities (b) Audio voice recording for later acoustic analysis, through the Kay Elemetrics Multi Dimensional Voice Program (c) Audio recording for later perceptual analysis through Consensus Auditory-Perceptual Evaluation of Voice (CAPE_V). It is believed that the search for evidence in clinical studies like this can contribute to awareness programs and vocal training for teachers.
- Conditions
- Voice Disorders
- Being tested
- Voice Amplification, Function Voice Exercises
- Keywords
- Voice disorders, Voice
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice AmplificationBehavioural
Behavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks.
Function Voice ExercisesBehavioural
Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.
| Study group | Role | What they receive |
|---|---|---|
| Function Voice Exercises | Experimental | Behavioral: Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week. Receives: Behavioral: Function Voice Exercises |
| Voice amplification | Experimental | Behavioral: Voice amplification Patients will use VA over a course of 6 weeks. Receives: Behavioral: Voice Amplification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fiberoptic endoscopic evaluation
Measured: One year
Score(CAPE_V); score(PPAV); score on acoustic analysis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Responsible party
- Principal investigator, Leticia Caldas Teixeira, Federal University of São Paulo
- Investigators
- Mara S Behlau, PhD, Study director, Universidade Federal de São PauloArnaldo L Colombo, PhD, Study director, Federal University of São PauloLetícia C Teixeira, MsC, Principal investigator, Federal University of São PauloAna Cristina C Gama, D, Study director, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196611
- Sponsor's protocol ID
- ETIC 0521.0.203.000-09
- Status last verified
- Sep 2010
- First submitted
- 3 Sep 2010
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The data of the participants are confidential
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
- ClinicalTrials.gov ID
- NCT01196611
- Acronym / sponsor ID
- ETIC 0521.0.203.000-09
- Conditions
- Voice Disorders
- Keywords
- Voice disorders, Voice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares two different approaches of voice therapy. Vocal Functional Exercises (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II - Tecnisystem do Brasil TSI 1210).
Detailed description
Both approaches combined with Vocal Hygiene Program (Behlau, 2007).The target population are female teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Vocal Functional Exercises and Voice Amplification are equally effective at improving vocal functioning in teachers with voice disorders. The Fiberoptic endoscopic evaluation will be done before randomization. All the participants will complete before and after a 6-week treatment phase (a) Voice Activity and Participation Profile (PPAV), an instrument designed to appraise the self-perceived psychosocial consequences of voice disorders to assess the impact of voice disorders on daily activities (b) Audio voice recording for later acoustic analysis, through the Kay Elemetrics Multi Dimensional Voice Program (c) Audio recording for later perceptual analysis through Consensus Auditory-Perceptual Evaluation of Voice (CAPE_V). It is believed that the search for evidence in clinical studies like this can contribute to awareness programs and vocal training for teachers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Function Voice Exercises | Experimental | Behavioral: Function Voice ExercisesBehavioral: Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week. |
| Voice amplification | Experimental | Behavioral: Voice AmplificationBehavioral: Voice amplification Patients will use VA over a course of 6 weeks. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female teacher
- 21-50 years old.
- Full or part time elementary to middle school teacher ( Prefeitura Municipal de Belo Horizonte).
- Minimum 20 hour weekly workload.
- Medical reference to speech therapy due to behavioral dysphonia
Key exclusion criteria (3 listed)
- Physical education or daycare teachers.
- Professional singers.
- Neurological and/or psychiatric voice disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice AmplificationBehavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks. | Behavioural | Voice amplification |
| Function Voice ExercisesFunction Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week. | Behavioural | Function Voice Exercises |
Primary outcome
Fiberoptic endoscopic evaluation
Time frame: One year
Score(CAPE_V); score(PPAV); score on acoustic analysis
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: No. The data of the participants are confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara S Behlau, PhD study director
Universidade Federal de São Paulo
Arnaldo L Colombo, PhD study director
Federal University of São Paulo
Letícia C Teixeira, MsC principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice Amplification and Function Voice Exercises in people with Voice Disorders, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fiberoptic endoscopic evaluation (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.