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Completed

NCT Number: NCT04858542

Evaluating the Impact of Vocal Health Education on Mask-wearing Workers During COVID-19

The purpose of this clinical trial is to understand how viewing educational health modules impacts vocal health behaviors in mask-wearing healthcare workers.

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Key information

Conditions

Health Behavior Behavior Communication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria McKenna

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Vocal Health Modules

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. Change in Relative fundamental frequency

    Time frame: Assessed prior to viewing modules, and then 1-week later

    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.

  2. Module Information Retention

    Time frame: Assessed at second session

    Answer question about the content of the modules (short answer, multiple choice, true/false)

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2021
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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