NCT07505953

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

February 9, 2026

Last Update Submit

March 27, 2026

Conditions

Operating RoomsProtective DevicesSpeech PerceptionCommunication Barriers

Keywords

COVID-19Listening effortSpeech perceptionPersonal protective equipment

Outcome Measures

Primary Outcomes (1)

  • Change in speech perception score under operating room PPE conditions

    Speech perception was assessed using a standardized speech perception test while participants were wearing operating room personal protective equipment.

    November 2021

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Operating room nurses and technicians

You may qualify if:

  • 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.

You may not qualify if:

  • presence of hearing and vestibular loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Prof

Study Record Dates

First Submitted

February 9, 2026

First Posted

April 1, 2026

Study Start

October 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

TU(1)