NCT07533916

Brief Summary

This prospective observational study aims to evaluate the effects of environmental noise in the intensive care unit on healthcare workers. Healthcare personnel working in intensive care units and hospital wards will be compared in terms of cochlear function, noise sensitivity, anxiety levels, perceived noise burden, and functional effects of noise exposure. The study seeks to determine whether long-term occupational exposure to intensive care unit noise is associated with measurable auditory and non-auditory effects in healthcare workers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2025

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

November 23, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

noisenoise exposureintensive care unitanxiety

Outcome Measures

Primary Outcomes (1)

  • Cochlear Function Assessed by DPOAE

    Cochlear function will be evaluated using distortion product otoacoustic emission (DPOAE) amplitudes and signal-to-noise ratio values, and compared between healthcare workers in the ICU group and the ward group.

    At baseline

Study Arms (2)

ICU group

Healthcare personnel actively working in intensive care units

Other: Intensive care unit environmental noise exposure

Ward group

Healthcare personnel actively working in hospital wards

Interventions

Occupational exposure to routine environmental noise in the intensive care unit setting during regular work activities.

ICU group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of volunteer healthcare personnel actively working in intensive care units and hospital wards at a tertiary training and research hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Intensive Care Specialist

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

November 23, 2025

Primary Completion

March 21, 2026

Study Completion

March 21, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because this study was conducted at a single center and no formal data-sharing plan was established at the time of study initiation.

Locations