- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05369663
Personal Protective Equipment Effects
May 10, 2022 updated by: ahmet mutlu, Istanbul Medeniyet University
Effects of Personal Protective Equipment on Speech Acoustics
Severe acute respiratory syndrome coronavirus-2 transmits through droplets; thus, oral, nasal, and conjunctival mucosas are related to contamination, and wearing personal protective equipment (PPE) is strongly suggested.
Several communication problems between the patient and healthcare workers related to PPE use are reported.
In this study, investigators aimed to investigate changes in the acoustic parameters of speech sounds when different PPE are used.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It was planned as a cross-sectional study enrolled 18 healthy male and female participants.
After the informed consent, participants were asked to pronounce a [ɑː] vowel for at least 3 seconds for voice quality estimation.
Afterward, all Turkish vowels were produced for a minimum of 200 ms.
Finally, three Turkish fricative consonants ([f], [s], [ʃ]) were produced in consonant/vowel/consonant format and in different vowel contexts within a carrier sentence.
Recordings were repeated for the following conditions: no PPE, surgical-mask, N99-mask, face shield, surgical-mask+faceshield, and N99+faceshield.
All recordings were analyzed with proper statistical methods.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34722
- Istanbul Medeniyet University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy individuals.
Based on health caregiving people (doctors, nurses)
Description
Inclusion Criteria:
- native Turkish speakers
Exclusion Criteria:
- having an acute respiratory system infection history of any vocal fold surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
no mask
no mask use
|
|
|
surgical mask
surgical mask use
|
face mask use
|
|
N99 mask
N99 mask use
|
face mask use
|
|
face shield
face shield use
|
face mask use
|
|
surgical mask+ faceshield
surgical mask+ faceshield use
|
face mask use
|
|
N99 mask+ faceshield
N99 mask+ faceshield use
|
face mask use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change on voice acoustics due to different personal protective equipments use
Time Frame: 1 months
|
speech material for six different conditions: no PPE,surgical mask,N99 mask,face shield,surgical mask+ face shield, N99+face shield were recorded with a microphone.Recordings were performed in a random order.
Obtained speech records were segmented according to the speech material and saved.
Each of the segmented files was analyzed using Praat software and related scripts.
The voice quality parameters were estimated on sustained [ɑː] vowels via Praat software (Praat is an open source software which enables voice acoustics analysis).
Mean values of the different formant frequencies and formant bandwidth frequency values at midpoints of the analyzed segments of the vowels were measured.
Spectral moments of the consonants were measured.
The formant and spectral moment were measured using Praat scripts.
All outcome measurements are in Hertz (Hz), so all measurements are held in primary outcome 1 measure section.
|
1 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ahmet mutlu, Istanbul Medeniyet University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2020
Primary Completion (Actual)
January 16, 2021
Study Completion (Actual)
February 16, 2021
Study Registration Dates
First Submitted
April 25, 2022
First Submitted That Met QC Criteria
May 6, 2022
First Posted (Actual)
May 11, 2022
Study Record Updates
Last Update Posted (Actual)
May 16, 2022
Last Update Submitted That Met QC Criteria
May 10, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Effects on speech acoustics
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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