- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03382535
Female Teacher's Voice During Teaching
The Well-being of Female Teacher's Voice During Teaching
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Due to the voice disorders, teachers are a major customer group for voice therapy. The main part of the study is comparison of two voice therapy methods.
There are several factors in the classroom that increase teacher's risk of voice disorders. One of the most significant is high noise level during lessons. This study explores the noise conditions the teachers are working in and how these conditions are related to the voice parameters and symptoms.
Finally, the study aims to determine whether classroom noise level can be lowered by improving classroom acoustics and by noise reducing workshops for teachers and pupils.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female teachers or teachers of special needs children from elementary schools
- Voice symptoms and willingness to participate in voice therapy
- Mother tongue Finnish
- No hearing loss, no need to use a hearing aid
- Non-smoking
- No neurological diseases
- No voice therapy during past year
- Successful phoniatric examination with rigid laryngoscopy or nasal endoscopy
Exclusion Criteria:
- Mother tongue other than Finnish
- Need to use a hearing aid
- Need for medical treatment in the larynx
- Abnormalities of the larynx
- Vocal cord paresis
- Laryngitis
- Posterior hypertrophy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Voice therapy
An individually tailored voice therapy where the order and length of voice treatment methods will depend on the nature of each subject's voice problems.
The intervention will take eight weeks and average of eight sessions (a' 45 min).
|
Voice therapy with direct and indirect therapy elements.
|
|
Experimental: Voice therapy with carryover strategies
A voice therapy as described above and an enhanced carryover program.
By carryover we mean the process of extending new vocal skills outside the clinic.
It includes supplementary tasks and reminders that will be tailored individually out of those direct and indirect methods that the subjects have adopted during therapy sessions.
Additionally, the teachers will be doing vocal warm-up and relaxation exercises together with their pupils int the beginning and in the middle of a school day.
The intervention will take eight weeks.
|
Voice therapy with direct and indirect therapy elements and supplementary tasks and reminders.
|
|
Other: Control group
No intervention during eight weeks since this group will act as a temporary control group.
After eight weeks, half of the participants in this group will be provided with Voice therapy and half with Voice therapy with carryover strategies.
|
No therapy during eight weeks.
After the control period half of the group will be provided with Voice therapy and half with Voice therapy with carryover strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of the well-being of the teachers' voice.
Time Frame: Up to one week before the interventions, up to one week after the interventions, 6 months after the interventions, 1 year and 2 years after the interventions and up to one week after the control time (concerning control group).
|
Subjective evaluation.Data collected with a questionnaire (Voice Activity and Participation Profile, VAPP) from the participants, answers given on a visual analogical scale (VAS) of 100 mm (0 = no disorder, 100 = extreme disorder).
|
Up to one week before the interventions, up to one week after the interventions, 6 months after the interventions, 1 year and 2 years after the interventions and up to one week after the control time (concerning control group).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sirpa M Pirilä, MA, Ooulu
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ooulu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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