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Prevention and Treatment of Voice Problems in Teachers (Prevention)

Primary Purpose

Voice Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
voice hygiene
VH + VP
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Voice Disorder focused on measuring Student teachers with normal or mildly disordered voices

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

voice hygiene

VH + VP

Arm Description

Subjects will receive training in voice hygiene

Outcomes

Primary Outcome Measures

Voice Handicap Index

Secondary Outcome Measures

Full Information

First Posted
October 21, 2009
Last Updated
January 21, 2016
Sponsor
University of Pittsburgh
Collaborators
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01199172
Brief Title
Prevention and Treatment of Voice Problems in Teachers
Acronym
Prevention
Official Title
Prospective Study of Prevention and Treatment of Voice Problems in Teachers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorder
Keywords
Student teachers with normal or mildly disordered voices

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
voice hygiene
Arm Type
Experimental
Arm Description
Subjects will receive training in voice hygiene
Arm Title
VH + VP
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
voice hygiene
Intervention Description
subjects will receive voice hygiene training
Intervention Type
Behavioral
Intervention Name(s)
VH + VP
Intervention Description
subjects will be trained in voice hygiene and voice production training
Primary Outcome Measure Information:
Title
Voice Handicap Index
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

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Prevention and Treatment of Voice Problems in Teachers

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