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Prevention and Treatment of Voice Problems in Teachers

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by University of Pittsburgh
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01199172
First received: October 21, 2009
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Voice Disorder
Behavioral: voice hygiene
Behavioral: VH + VP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Prospective Study of Prevention and Treatment of Voice Problems in Teachers

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Voice Handicap Index [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: October 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199172

Contacts
Contact: Katherine Verolini Abbott, PhD 412-383-6544 kav25@pitt.edu
Contact: Amanda I Gillespie, MS 412-383-6709 aig7@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Katherine Verdolini Abbott, PhD    412-383-6544    kav25@pitt.edu   
Contact: Amanda I Gillespie, MS    412-383-6709    aig7@pitt.edu   
Principal Investigator: Kathering Verdolini Abbott, PhD         
Sponsors and Collaborators
University of Pittsburgh
The University of Hong Kong
  More Information

No publications provided

Responsible Party: Katherine Verdolini Abbott, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01199172     History of Changes
Other Study ID Numbers: 8567, 1R01DC8567-1A2
Study First Received: October 21, 2009
Last Updated: September 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Student teachers with normal or mildly disordered voices

Additional relevant MeSH terms:
Voice Disorders
Laryngeal Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014