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

Sponsor
University of Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT04858542
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational Vocal Health Modules
N/A

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

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 26, 2021
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mask-wearing healthcare workers

All participants in this arm will view the educational health modules and their subjective/objective outcomes will be measure pre/post module viewing.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in amount of Vocal Effort after 1 week [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 [Assessed immediately after viewing the modules]

    Answer questions about the content of the module (short answer, multiple choice, true/false)

Secondary Outcome Measures

  1. Change in Relative fundamental frequency [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 [Assessed at second session]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Victoria McKenna Cincinnati Ohio United States 45267

Sponsors and Collaborators

  • University of Cincinnati

Investigators

  • Principal Investigator: Victoria McKenna, Ph.D., University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Victoria McKenna, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT04858542
Other Study ID Numbers:
  • 2020-0889
First Posted:
Apr 26, 2021
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Victoria McKenna, Assistant Professor, University of Cincinnati

Study Results

No Results Posted as of Jan 4, 2022