The Effects of Operating Room COVID-19 Personal Protectiv... | NCT07505953

Studies
The Effects of Operating Room COVID-19 Personal Protective Equipment on Speech Perception and Listening Effort

NCT07505953

Sponsor

Ondokuz Mayıs University

Status

Completed

Last Update Posted

Apr 1, 2026Actual

Enrollment

219Actual

Phase

Not provided

Conditions

Speech Perception
Communication Barriers
Operating Rooms
Protective Devices

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Nov 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Mar 27, 2026

First Posted Date

Apr 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2026

Last Update Posted Date

Apr 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

219Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Operating room nurses and technicians

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biruni University		Istanbul			Turkey (Türkiye)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 2, 2026	Mar 27, 2026	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided