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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04858542
Other study ID # 2020-0889
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 26, 2021
Est. completion date September 1, 2021

Study information

Verified date December 2021
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date September 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - English Speaker - Occupational voice user who is required to wear a mask at work Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational Vocal Health Modules
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.

Locations

Country Name City State
United States Victoria McKenna Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Assessed prior to module viewing and again 1-week later
Primary Learning of Health Information Answer questions about the content of the module (short answer, multiple choice, true/false) Assessed immediately after viewing the modules
Secondary 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. Assessed prior to viewing modules, and then 1-week later
Secondary Module Information Retention Answer question about the content of the modules (short answer, multiple choice, true/false) Assessed at second session
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