Health BehaviorNCT04858542
Evaluating the Impact of Vocal Health Education on Mask-wearing Workers During COVID-19
A study testing Educational Vocal Health Modules in people with Health Behavior, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this clinical trial is to understand how viewing educational health modules impacts vocal health behaviors in mask-wearing healthcare workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Educational Vocal Health Modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 1 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Speaker
- Occupational voice user who is required to wear a mask at work
Who cannot join
- History of neurological disorder or disease
- History of head/neck cancer
- Current speech, language, voice, or hearing problem/disorder
- Currently sick or have been sick within the last 14 days, or is waiting on a COVID-19 test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Educational Modules to Improve Communication and Vocal Health Among Mask-wearing Healthcare Workers: Phase 2 of the COVID-19 Critical Community Challenge Grant
The purpose of this clinical trial is to understand how viewing educational health modules impacts vocal health behaviors in mask-wearing healthcare workers.
Read the detailed description
Results of the investigators' previous work showed that mask-wearing healthcare workers have difficulty with voice and communication. Healthcare workers reported significant increases in vocal effort and dyspnea while wearing masks, and showed greater effort and poorer vocal quality at the end of the workday compared to the beginning of the day. Despite these negative changes, very few healthcare workers reported using any type of communication strategy (e.g., taking breaks, using gestures). Therefore, the investigators developed educational modules to address the voice and communication problems facing this population. This clinical trial plans to evaluate how these educational modules impact subjective/objective voice and communication measures in mask-wearing healthcare workers.
- Conditions
- Health Behavior
- Being tested
- Educational Vocal Health Modules
- Keywords
- voice, communication
- Medical subject headings
- Health Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Vocal Health ModulesBehavioural
We have developed four educational health modules (total duration of approximately 30 minutes). First, these modules explain how masks impact communication and voice, then they describe health strategies to improve communication and voice, and finally, they give real-life examples of how the strategies can be implemented into the work setting.
| Study group | Role | What they receive |
|---|---|---|
| Mask-wearing healthcare workers | Experimental | All participants in this arm will view the educational health modules and their subjective/objective outcomes will be measure pre/post module viewing. Receives: Behavioral: Educational Vocal Health Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amount of Vocal Effort after 1 week
A self-perceptual rating of voice exertion and how hard it is to make a voice. The vocal effort scale will be rated on a 100-mm visual analog scale in which the left side (score of 0) indicates "no effort" to produce a voice, and the right side (score of 100) indicates "the most effort" to create a voice.
Measured: Assessed prior to module viewing and again 1-week later
Learning of Health Information
Answer questions about the content of the module (short answer, multiple choice, true/false)
Measured: Assessed immediately after viewing the modules
Secondary outcomes (2)
Change in Relative fundamental frequency
An acoustic measure that characterizes change in fundamental frequency during voicing transitions. Participants will complete vowel-voiceless consonant-vowel combinations (e.g., /ifi/) and relative fundamental frequency will be determined.
Measured: Assessed prior to viewing modules, and then 1-week later
Module Information Retention
Answer question about the content of the modules (short answer, multiple choice, true/false)
Measured: Assessed at second session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start26 Feb 2021
- Primary completion1 May 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria McKenna, University of Cincinnati
- Investigators
- Victoria McKenna, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858542
- Sponsor's protocol ID
- 2020-0889
- Status last verified
- Dec 2021
- First submitted
- 22 Mar 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Educational Modules to Improve Communication and Vocal Health Among Mask-wearing Healthcare Workers: Phase 2 of the COVID-19 Critical Community Challenge Grant
- ClinicalTrials.gov ID
- NCT04858542
- Acronym / sponsor ID
- 2020-0889
- Conditions
- Health Behavior
- Keywords
- voice, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 26 Apr 2021 (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.
The purpose of this clinical trial is to understand how viewing educational health modules impacts vocal health behaviors in mask-wearing healthcare workers.
Detailed description
Results of the investigators' previous work showed that mask-wearing healthcare workers have difficulty with voice and communication. Healthcare workers reported significant increases in vocal effort and dyspnea while wearing masks, and showed greater effort and poorer vocal quality at the end of the workday compared to the beginning of the day. Despite these negative changes, very few healthcare workers reported using any type of communication strategy (e.g., taking breaks, using gestures). Therefore, the investigators developed educational modules to address the voice and communication problems facing this population. This clinical trial plans to evaluate how these educational modules impact subjective/objective voice and communication measures in mask-wearing healthcare workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mask-wearing healthcare workers | Experimental | Behavioral: Educational Vocal Health ModulesAll participants in this arm will view the educational health modules and their subjective/objective outcomes will be measure pre/post module viewing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English Speaker
- Occupational voice user who is required to wear a mask at work
Key exclusion criteria (4 listed)
- History of neurological disorder or disease
- History of head/neck cancer
- Current speech, language, voice, or hearing problem/disorder
- Currently sick or have been sick within the last 14 days, or is waiting on a COVID-19 test result
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 |
|---|---|---|
| Educational Vocal Health ModulesWe have developed four educational health modules (total duration of approximately 30 minutes). First, these modules explain how masks impact communication and voice, then they describe health strategies to improve communication and voice, and finally, they give real-life examples of how the strategies can be implemented into the work setting. | Behavioural | Mask-wearing healthcare workers |
Primary outcome
Change in amount of Vocal Effort after 1 week
Time frame: Assessed prior to module viewing and again 1-week later
A self-perceptual rating of voice exertion and how hard it is to make a voice. The vocal effort scale will be rated on a 100-mm visual analog scale in which the left side (score of 0) indicates "no effort" to produce a voice, and the right side (score of 100) indicates "the most effort" to create a voice.
Learning of Health Information
Time frame: Assessed immediately after viewing the modules
Answer questions about the content of the module (short answer, multiple choice, true/false)
2 secondary outcomes
Change in Relative fundamental frequency
Time frame: Assessed prior to viewing modules, and then 1-week later
Module Information Retention
Time frame: Assessed at second session
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 4 Jan 2022.
- Lab website with contact informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Victoria McKenna, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Vocal Health Modules in people with Health Behavior, run by University of Cincinnati at 1 site in United States.
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 4 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 4 Jan 2022. 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 United States. 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?
Change in amount of Vocal Effort after 1 week (time frame: Assessed prior to module viewing and again 1-week later). The study lists 2 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 4 Jan 2022.