Functional Voice DisorderNCT03382535
Female Teacher's Voice During Teaching
A study testing Voice therapy and Voice therapy with carryover strategies in people with Functional Voice Disorder, run by University of Oulu.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Functional Voice Disorder
- What is being tested?
- Voice therapy and Voice therapy with carryover strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2009to 14 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Well-being of Female Teacher's Voice During Teaching
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.
Read the 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.
- Conditions
- Functional Voice Disorder
- Being tested
- Voice therapy, Voice therapy with carryover strategies, Control group
- Keywords
- Voice disorder, Teacher's voice, Voice SPL (Voice sound pressure level), Voice F0 (Voice fundamental frequency), Voice therapy, Voice accumulator, Activity noise, Classroom
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice therapyBehavioural
Voice therapy with direct and indirect therapy elements.
Voice therapy with carryover strategiesBehavioural
Voice therapy with direct and indirect therapy elements and supplementary tasks and reminders.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Voice therapy | Active comparator | 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). Receives: Behavioral: Voice therapy |
| Voice therapy with carryover strategies | Experimental | 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. Receives: Behavioral: Voice therapy with carryover strategies |
| Control group | Other | 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start7 Dec 2009
- Primary completion20 Dec 2014
- Study completion14 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Voice DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Oulu University Hospital, Umeå University, Sonvox AB
- Responsible party
- Sponsor
- Investigators
- Sirpa M Pirilä, MA, Study chair, Ooulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382535
- Sponsor's protocol ID
- Ooulu
- Status last verified
- Dec 2017
- First submitted
- 1 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Well-being of Female Teacher's Voice During Teaching
- ClinicalTrials.gov ID
- NCT03382535
- Acronym / sponsor ID
- Ooulu
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Tampere University, Oulu University Hospital, Umeå University, Sonvox AB
- Study start
- 7 Dec 2009 (actual)
- Primary completion
- 20 Dec 2014 (actual)
- Study completion
- 14 Jun 2016 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Voice therapy | Active comparator | Behavioral: Voice therapyAn 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 carryover strategies | Experimental | Behavioral: Voice therapy with carryover strategiesA 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. |
| Control group | Other | Other: Control groupNo 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice therapyVoice therapy with direct and indirect therapy elements. | Behavioural | Voice therapy |
| Voice therapy with carryover strategiesVoice therapy with direct and indirect therapy elements and supplementary tasks and reminders. | Behavioural | Voice therapy with carryover strategies |
| Control groupNo 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. | Other | Control group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirpa M Pirilä, MA study chair
Ooulu
Questions about this trial
What is this clinical trial studying?
A study testing Voice therapy and Voice therapy with carryover strategies in people with Functional Voice Disorder, run by University of Oulu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.