NCT03382535

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

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

December 7, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

5 years

First QC Date

December 1, 2017

Last Update Submit

December 18, 2017

Conditions

Keywords

Voice disorderTeacher's voiceVoice SPL (Voice sound pressure level)Voice F0 (Voice fundamental frequency)Voice therapyVoice accumulatorActivity noiseClassroom

Outcome Measures

Primary Outcomes (1)

  • 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).

    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).

Study Arms (3)

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).

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.

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.

Other: Control group

Interventions

Voice therapyBEHAVIORAL

Voice therapy with direct and indirect therapy elements.

Voice therapy

Voice therapy with direct and indirect therapy elements and supplementary tasks and reminders.

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.

Control group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Voice Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sirpa M Pirilä, MA

    Ooulu

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not told what kind of a therapy they are receiving.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 26, 2017

Study Start

December 7, 2009

Primary Completion

December 20, 2014

Study Completion

June 14, 2016

Last Updated

December 26, 2017

Record last verified: 2017-12