Back to resultsFemale Teacher's Voice During Teaching
Primary Purpose
Functional Voice Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Voice therapy
Voice therapy with carryover strategies
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Functional Voice Disorder focused on measuring Voice disorder, Teacher's voice, Voice SPL (Voice sound pressure level), Voice F0 (Voice fundamental frequency), Voice therapy, Voice accumulator, Activity noise, Classroom
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
Voice therapy
Voice therapy with carryover strategies
Control group
Arm Description
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).
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.
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.
Outcomes
Primary Outcome Measures
The change of the well-being of the teachers' voice.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03382535
First Posted
December 1, 2017
Last Updated
December 18, 2017
Sponsor
University of Oulu
Collaborators
Tampere University, Oulu University Hospital, Umeå University, Sonvox AB
1. Study Identification
Unique Protocol Identification Number
NCT03382535
Brief Title
Female Teacher's Voice During Teaching
Official Title
The Well-being of Female Teacher's Voice During Teaching
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 7, 2009 (Actual)
Primary Completion Date
December 20, 2014 (Actual)
Study Completion Date
June 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
Tampere University, Oulu University Hospital, Umeå University, Sonvox AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Two voice therapy methods are compared. Activity noise levels and vocal load of teachers during teaching in primary school classrooms are evaluated. Acoustic and Workshop Interventions are implemented in order to reduce noise level during lesson.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Voice Disorder
Keywords
Voice disorder, Teacher's voice, Voice SPL (Voice sound pressure level), Voice F0 (Voice fundamental frequency), Voice therapy, Voice accumulator, Activity noise, Classroom
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly divided into three groups. Group 1: Voice therapy. Group 2: Voice therapy with carryover strategies (supplementary tasks and reminders).
Group 3. Controls. No treatment during control period. After the control period participants are having Voice therapy or Voice therapy with carryover strategies.
Masking
Participant
Masking Description
Participants are not told what kind of a therapy they are receiving.
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voice therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Voice therapy with carryover strategies
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy
Intervention Description
Voice therapy with direct and indirect therapy elements.
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy with carryover strategies
Intervention Description
Voice therapy with direct and indirect therapy elements and supplementary tasks and reminders.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of the well-being of the teachers' voice.
Description
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).
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).
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirpa M Pirilä, MA
Organizational Affiliation
Ooulu
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Female Teacher's Voice During Teaching
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