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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: Educational Vocal Health Modules

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Victoria McKenna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Module Information Retention	Answer question about the content of the modules (short answer, multiple choice, true/false)	Assessed at second session

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Lab website with contact information

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: communication; voice
• Other Study ID Numbers: 2020-0889 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No