Prevention and Treatment of Voice Problems in Teachers (Prevention)

January 21, 2016 updated by: Kittie Verdolini Abbott, University of Pittsburgh

Prospective Study of Prevention and Treatment of Voice Problems in Teachers

The proposed series addresses the prevention and treatment of voice problems in teachers. Data in the literature clearly identify voice disorders as teachers' primary occupational risk not only in the U.S. but also internationally. Moreover, voice problems constitute a global women's health concern. Until recently, few reports have been available around the treatment of these problems in teachers, and even fewer have addressed the equally important question of prevention. The present studies are conducted within the context of a long-range goal to identify effective intervention methodologies for both the prevention and treatment of voice problems in teachers taking into consideration multicultural and linguistic factors. The present studies will report pragmatic data around the effectiveness of two theoretically-driven approaches to the prevention and treatment of voice problems in teachers, (a) voice hygiene education (VH) and (b) voice hygiene education + voice production training in "resonant voice" (VH+VP, essentially the Lessac-Madsen Resonant Voice Therapy program). Participants will be student teachers in Pittsburgh and Hong Kong, who will be followed from student teaching across their second full year of employment as a professional teacher. The central aims are: [1] to evaluate the effectiveness of VH and VH+VP for the prevention of future voice problems in student teachers who are vocally healthy at the outset of the protocol, versus the treatment of voice problems in student teachers who already have them at some level; [2] to evaluate the generality of the findings across teachers in the U.S. and China, using appropriate linguistic and cultural adaptations of the interventions; and [3] to evaluate the feasibility of an internet-based voice exercise and reporting program as a supplement to face-to-face interventions. Ergonomic and personal factors will also be evaluated for their differential ability to predict the risk for future voice problems in teachers. The results should be useful at a practical level, and should also lay the groundwork for future studies assessing similar issues around the prevention of voice problems in teachers, in particular as influenced by multicultural factors within the U.S. The results should also be useful for future studies investigating causal pathways in interventions around these problems.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

By self-report in person or over the phone: (a) 21-40 yr; (b) no current self-perceived voice problem;(c) student teacher in the final year of formal education prior to the initiation of employment as a teacher and imminent start of the first formal teaching practicum; (d) availability and willingness to attend up to an 8-hr group intervention on 1 of 2 days when it will be offered the week before the start of student teaching, willingness to be randomized to one of three groups, and stated willingness to persist with the entire 2.5-yr protocol, which will involve baseline, 1-mo, 3-mo, 1-yr,and 2-yr follow-up measures, and two separate interventions followed by a 4-wk hygiene reporting and potentially voice exercise period for intervention groups; (e) intention to obtain employment as a teacher in the school year following graduation; (f) no degenerative or other medical conditions or medications that would affect voice, with the exception of seasonal allergies (and their treatment) or laryngopharyngeal reflux (LPR; and its treatment).

· By clinical evaluation, for students satisfying the self-report criteria: (g) nasal patency sufficient at least unilaterally for the passage of a flexible scope; (h) no history or suspected allergy to any local anesthetic or evidence that a laryngeal exam can be conducted without it; (i) acceptably controllable gag reflex; (j) overall voice quality score < 15 on a 100-mm visual analogue scale, following standardized procedures (see D.2.4.1), together with a total VHI score < 17 and normal larynx (D.2.4.1; "low-starter group"-assuming the subject has indicated normal voice by self report, or overall voice quality score < 20, together with a total VHI score > 25 and either normal larynx or mildly impaired larynx not held to require clinical attention outside the auspices of the protocol(D.2.4.1; "high-starter group")-if the subject has indicated normal voice or at most mild, intermittent voice problems by self report; and (k) normal hearing bilaterally (30 dB at 125, 250, 500, 1000, 2000, 4000, and 8000 Hz in the better ear).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control
EXPERIMENTAL: voice hygiene
Subjects will receive training in voice hygiene
Behavioral: voice hygiene
subjects will receive voice hygiene training
EXPERIMENTAL: VH + VP
Behavioral: VH + VP
subjects will be trained in voice hygiene and voice production training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Voice Handicap Index
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8567
  • 1R01DC8567-1A2

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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