NCT01199172

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

6 years

First QC Date

October 21, 2009

Last Update Submit

January 21, 2016

Conditions

Keywords

Student teachers with normal or mildly disordered voices

Outcome Measures

Primary Outcomes (1)

  • Voice Handicap Index

    5 years

Study Arms (3)

Control

NO INTERVENTION

voice hygiene

EXPERIMENTAL

Subjects will receive training in voice hygiene

Behavioral: voice hygiene

VH + VP

EXPERIMENTAL
Behavioral: VH + VP

Interventions

voice hygieneBEHAVIORAL

subjects will receive voice hygiene training

voice hygiene
VH + VPBEHAVIORAL

subjects will be trained in voice hygiene and voice production training

VH + VP

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2009

First Posted

September 10, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations