Personal Protective Equipment Effects

Completed

• Conditions: Voice Disorders; Speech Disorders
• Interventions: Device: mask use

• Registration Number: NCT05369663
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

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.

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 Timeline

• Study Start: 2020-12-16
• Primary Completion: 2021-01-16
• Study Completion: 2021-02-16
• Study First Submitted: 2022-04-25
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-10
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• native Turkish speakers

Exclusion Criteria

• having an acute respiratory system infection history of any vocal fold surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
N99 mask	mask use	N99 mask use
face shield	mask use	face shield use
surgical mask+ faceshield	mask use	surgical mask+ faceshield use
surgical mask	mask use	surgical mask use
N99 mask+ faceshield	mask use	N99 mask+ faceshield use

Primary Outcome Measures

Name	Time	Method
The change on voice acoustics due to different personal protective equipments use	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.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Turkey