NCT04096352

Brief Summary

Scientific literature supports that teachers are at greater risk for voice disorders than the general population. In the classroom, the teacher's voice represents the main communication tool. Optimal voice use is indispensable to ensure effective teaching and preserve the teacher's vocal health. This project investigates how virtual reality (VR) facilitates the learning of effective vocal skills and their application in real-world contexts. Based on acoustic analyses and self-assessment scales, the investigators compare 100 future teachers randomly assigned in two groups. The experimental group (n=50) receives a voice training by VR simulations and voice information. The control group (n=50) only receives voice information.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

September 6, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 29, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

September 6, 2019

Last Update Submit

April 6, 2020

Conditions

Voice DisordersVirtual Reality Therapy

Keywords

Speech TherapyVirtual RealityTeacher's voiceBackground NoiseSchool Teachers

Outcome Measures

Primary Outcomes (5)

  • Self-perceived voice changes between the baseline and the end of the intervention

    Self-assessment of perceived vocal effort using the Adapted BORG Category Ratio (CR-10) physical exertion scale. On the scale, verbal expressions regarding vocal effort are anchored to the correct positions on a logarithmic ratio scale from zero (No vocal effort at all) to 10 (Maximum vocal effort), according to their quantitative meaning.

    3 weeks

  • Voice frequency changes between the baseline and the end of the intervention

    Acoustic measurements of participants' voice frequency (in hertz) when speaking with and without background noise.

    3 weeks

  • Voice intensity changes between the baseline and the end of the intervention

    Acoustic measurements of participants' voice intensity (in dB) when speaking with and without background noise.

    3 weeks

  • Voice spectrum changes between the baseline and the end of the intervention

    Acoustic measurements of participants' voice spectrum (in Hertz) when speaking with and without background noise.

    3 weeks

  • Speech rate changes between the baseline and the end of the intervention

    Measurements of participants' speech rate (in syllables per second) when speaking with and without background noise.

    3 weeks

Study Arms (2)

Indirect+Direct method

EXPERIMENTAL

Indirect method: one session of information on voice function and voice hygiene. Direct method: three sessions of voice training using virtual reality simulations over a course of 3 weeks.

Behavioral: Direct MethodBehavioral: Indirect Method

Indirect method

ACTIVE COMPARATOR

Indirect method: one session of information on voice function and voice hygiene.

Behavioral: Indirect Method

Interventions

Direct MethodBEHAVIORAL

Learning effective vocal skills using speech therapy exercises and virtual reality simulations.

Indirect+Direct method
Indirect MethodBEHAVIORAL

Information on voice function and voice hygiene.

Indirect methodIndirect+Direct method

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • future teacher having completed at least one internship as a schoolteacher
  • speaking French fluently

You may not qualify if:

  • hearing impairment
  • voice pathology at the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Liège

Liège, Wallonia, 4000, Belgium

Location

MeSH Terms

Conditions

Voice DisordersCommunication Disorders

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Angélique Remacle, Ph.D.

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 19, 2019

Study Start

September 29, 2019

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

BE(1)