- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505953
The Effects of Operating Room COVID-19 Personal Protective Equipment on Speech Perception and Listening Effort
BACKGROUND: The aim of this study is to evaluate the effects of the combination surgical mask+N95 mask+face shield in operating room on speech perception and listening effort during the COVID-19 process.
METHODS: The experimental part of the study was carried out in three phases. Thirty-five participants who were found to have normal hearing in Phase I were included in Phase II and Phase III. Speech stimuli were given with a surgical mask in phase II, and a combination of surgical mask+N95 mask+face shield in phase III. The tests performed in free field, in the presence of 60 dB wideband background noise. In the descriptive part of the study, the listening effort of 184 operating room professionals was examined with a 17-item questionnaire.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Biruni University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inclusion Criteria:
- Operating room nurses and technicians whose medical history was not a vestibular disease and ear surgery, who were shown to have normal hearing (NH) by hearing tests.
Exclusion Criteria:
- presence of hearing and vestibular loss
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in speech perception score under operating room PPE conditions
Time Frame: November 2021
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Speech perception was assessed using a standardized speech perception test while participants were wearing operating room personal protective equipment.
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November 2021
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Thesis Kübra
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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