- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533916
ICU Environmental Noise and Healthcare Workers (ICU-Noise)
Evaluation of the Effects of Intensive Care Unit Environmental Noise on Healthcare Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective observational study is designed to evaluate the potential auditory and non-auditory effects of intensive care unit environmental noise on healthcare workers. The study is being conducted in a tertiary training and research hospital and includes volunteer healthcare personnel working in intensive care units and hospital wards. Participants are classified according to their work setting, and comparisons are performed between the intensive care unit group and the ward group.
The study focuses on occupational exposure to the intensive care environment and its possible association with cochlear function, perceived noise burden, noise sensitivity, anxiety levels, and functional effects related to workplace noise. Audiological assessment includes distortion product otoacoustic emission measurements, and questionnaire-based assessments are used to evaluate perceived noise-related burden and associated psychological and functional effects. The study aims to determine whether prolonged work in the intensive care environment is associated with measurable changes in hearing-related parameters and subjective outcomes when compared with work in hospital wards.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Izmir, Turkey (Türkiye)
- Izmir Tepecik Training and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age ≥18 years, Actively working in the Anesthesiology and Reanimation ICU, or in a hospital ward, Voluntary participation in the study,
Exclusion Criteria:
Age <18 years, Pregnancy, Previously diagnosed hearing loss, History of head trauma, History of ear surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ICU group
Healthcare personnel actively working in intensive care units
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Occupational exposure to routine environmental noise in the intensive care unit setting during regular work activities.
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Ward group
Healthcare personnel actively working in hospital wards
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cochlear Function Assessed by DPOAE
Time Frame: At baseline
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TepecikTRH
- 2022/12-36 (Other Identifier: Tepecik Training and Research Hospital Ethics Committee Approval No: 2022/12-36, dated January 11, 2023)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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