NCT04858542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

March 22, 2021

Last Update Submit

December 31, 2021

Conditions

Keywords

voicecommunication

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in Relative fundamental frequency

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

  • Module Information Retention

    Assessed at second session

Study Arms (1)

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.

Behavioral: Educational Vocal Health Modules

Interventions

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.

Mask-wearing healthcare workers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English Speaker
  • Occupational voice user who is required to wear a mask at work

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria McKenna

Cincinnati, Ohio, 45267, United States

Location

Related Links

MeSH Terms

Conditions

Health BehaviorCommunication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Victoria McKenna, Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 26, 2021

Study Start

February 26, 2021

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations