Voice DisordersVirtuVoxNCT04096352
Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox)
A study testing Direct Method and Indirect Method in people with Voice Disorders and Virtual Reality Therapy, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders, Virtual Reality Therapy
- What is being tested?
- Direct Method and Indirect Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Sep 2019to 20 Feb 2020
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- future teacher having completed at least one internship as a schoolteacher
- speaking French fluently
Who cannot join
- hearing impairment
- voice pathology at the time of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox): Randomized Controlled Trial
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.
Read the detailed description
Experimental group participants receive direct method (three 1-hour sessions of voice training by virtual reality simulations over a course of 3 weeks) and indirect method (one 1-hour session of information on voice function and voice hygiene). Control group participants receive indirect method (one 1-hour session of information on voice function and voice hygiene).
- Conditions
- Voice Disorders, Virtual Reality Therapy
- Being tested
- Direct Method, Indirect Method
- Keywords
- Speech Therapy, Virtual Reality, Teacher's voice, Background Noise, School Teachers
- Medical subject headings
- Voice Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct MethodBehavioural
Learning effective vocal skills using speech therapy exercises and virtual reality simulations.
Indirect MethodBehavioural
Information on voice function and voice hygiene.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Direct Method; Behavioral: Indirect Method |
| Indirect method | Active comparator | Indirect method: one session of information on voice function and voice hygiene. Receives: Behavioral: Indirect Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start29 Sep 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Universite du Quebec en Outaouais
- Responsible party
- Principal investigator, Remacle Angélique, University of Liege
- Investigators
- Angélique Remacle, Ph.D., Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096352
- Sponsor's protocol ID
- VirtuVox2
- Acronym
- VirtuVox
- Status last verified
- Apr 2020
- First submitted
- 6 Sep 2019
- Last updated
- 7 Apr 2020
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04096352
- Acronym / sponsor ID
- VirtuVox / VirtuVox2
- Conditions
- Voice Disorders, Virtual Reality Therapy
- Keywords
- Speech Therapy, Virtual Reality, Teacher's voice, Background Noise, School Teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Universite du Quebec en Outaouais
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 19 Sep 2019 (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.
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.
Detailed description
Experimental group participants receive direct method (three 1-hour sessions of voice training by virtual reality simulations over a course of 3 weeks) and indirect method (one 1-hour session of information on voice function and voice hygiene). Control group participants receive indirect method (one 1-hour session of information on voice function and voice hygiene).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirect+Direct method | Experimental | Behavioral: Direct Method, Behavioral: Indirect MethodIndirect 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. |
| Indirect method | Active comparator | Behavioral: Indirect MethodIndirect method: one session of information on voice function and voice hygiene. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- future teacher having completed at least one internship as a schoolteacher
- speaking French fluently
Key exclusion criteria (2 listed)
- hearing impairment
- voice pathology at the time of the study
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 |
|---|---|---|
| Direct MethodLearning effective vocal skills using speech therapy exercises and virtual reality simulations. | Behavioural | Indirect+Direct method |
| Indirect MethodInformation on voice function and voice hygiene. | Behavioural | Indirect method, Indirect+Direct method |
Primary outcome
Self-perceived voice changes between the baseline and the end of the intervention
Time frame: 3 weeks
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.
Voice frequency changes between the baseline and the end of the intervention
Time frame: 3 weeks
Acoustic measurements of participants' voice frequency (in hertz) when speaking with and without background noise.
Voice intensity changes between the baseline and the end of the intervention
Time frame: 3 weeks
Acoustic measurements of participants' voice intensity (in dB) when speaking with and without background noise.
Voice spectrum changes between the baseline and the end of the intervention
Time frame: 3 weeks
Acoustic measurements of participants' voice spectrum (in Hertz) when speaking with and without background noise.
Speech rate changes between the baseline and the end of the intervention
Time frame: 3 weeks
Measurements of participants' speech rate (in syllables per second) when speaking with and without background noise.
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 7 Apr 2020.
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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.
Angélique Remacle, Ph.D. principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Method and Indirect Method in people with Voice Disorders and Virtual Reality Therapy, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 2 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Self-perceived voice changes between the baseline and the end of the intervention (time frame: 3 weeks). The study lists 5 primary outcomes in all. 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 7 Apr 2020.