- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437443
Burnout, Secondary Traumatic Stress and Inflammatory Biomarkers in ICU Healthcare Workers
Relationship Between Burnout, Secondary Traumatic Stress, and Inflammatory Biomarkers in Intensive Care Unit Healthcare Workers
Healthcare professionals working in intensive care units (ICUs) are frequently exposed to high levels of psychological stress due to critically ill patients, frequent encounters with death, complex clinical decision-making, and prolonged working hours. This environment increases the risk of burnout and secondary traumatic stress, which may not only affect mental well-being but also have measurable physiological consequences.
Emerging evidence suggests that chronic psychological stress and burnout may influence immune function through activation of proinflammatory pathways. Elevated levels of inflammatory biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and neutrophil-to-lymphocyte ratio (NLR) have been associated with stress-related conditions. However, data examining the relationship between burnout, secondary traumatic stress, and inflammatory biomarkers in intensive care healthcare workers remain limited.
This cross-sectional observational study aims to investigate the association between burnout and secondary traumatic stress levels, assessed using validated psychometric instruments (Maslach Burnout Inventory and Professional Quality of Life Scale), and inflammatory biomarkers (CRP, IL-6, TNF-α, and NLR) in ICU healthcare workers. Blood samples will be obtained in conjunction with routine annual health screening, and additional serum samples will be collected for biomarker analysis. The study seeks to clarify the psychoneuroimmunological mechanisms underlying occupational stress in critical care settings.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Elâzığ
-
Elâzığ, Elâzığ, Turkey (Türkiye), 23100
- Fethi Sekin City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
Active employment in an intensive care unit (anesthesia, internal medicine, or chest diseases ICU)
Participation in routine annual occupational health screening
Willingness to provide additional blood sample for research purposes
Voluntary participation with written informed consent
Exclusion Criteria:
- Active infection at the time of assessment
Use of systemic steroids, immunosuppressive agents, or chemotherapy within the last 4 weeks
Known autoimmune or rheumatologic disease
Hematologic malignancy or severe hematologic disorder
Pregnancy
Refusal to provide additional blood sample
Incomplete questionnaire data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ICU Healthcare Workers
Healthcare professionals aged 18 years and older working in intensive care units (anesthesia, internal medicine, and chest diseases ICUs) who voluntarily participate in the study.
Participants will complete validated psychometric scales assessing burnout and secondary traumatic stress, and blood samples will be collected for inflammatory biomarker analysis.
|
Administration of validated burnout and secondary traumatic stress questionnaires and collection of blood samples for inflammatory biomarker analysis.
No therapeutic or clinical intervention is performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association Between Burnout Levels and Inflammatory Biomarkers
Time Frame: At the time of assessment (single time point)
|
Evaluation of the relationship between Maslach Burnout Inventory (MBI-HSS) total and subscale scores and inflammatory biomarker levels (CRP, IL-6, TNF-α, and NLR) using correlation and multivariable linear regression analysis.
|
At the time of assessment (single time point)
|
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
- Pathologic Processes
- Behavioral Symptoms
- Stress, Psychological
- Occupational Diseases
- Fatigue
- Mental Fatigue
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Burnout, Psychological
- Compassion Fatigue
- Occupational Stress
- Inflammation
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- EFSH-ICU-STRESS-2026-22-35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Center for Research and Innovation Viña Concha...Universidad Católica del MauleNot yet recruitingInflammaging | Antioxidant Status, Inflammation | Inflammation Biomarkers | Antioxidant Capabilities | Cardiometabolic Health IndicatorsChile
-
University of NebraskaNot yet recruiting
-
Laboratorios Sophia S.A de C.V.CompletedOcular Inflammation | Ocular Pain | Pterygium | Post-surgical InflammationMexico
-
Central Hospital, Nancy, FranceRecruiting
-
Oral Science International Inc.AdvarraNot yet recruiting
-
University of NebraskaCompletedPeriodontal InflammationUnited States
-
University of California, DavisCompleted
Clinical Trials on Psychometric Assessment and Blood Sampling
-
Assiut UniversityCompletedCognitive Dysfunction | Hypercholesterolemia | HyperhomocysteinemiaEgypt
-
Cairo UniversityCompletedObsessive-Compulsive Disorder | Suicide | Bipolar I Disorder | ObsessionsEgypt
-
Hospital Universitario La FeUnknownCancer | Psychological Distress | Hereditary Diseases | Genetic CounselingSpain
-
Central Hospital, Nancy, FranceCompletedDiastolic Heart Failure
-
GlaxoSmithKlineThe PATH Malaria Vaccine Initiative (MVI)CompletedMalaria | Malaria VaccinesGhana, Tanzania, Gabon, Kenya, Burkina Faso, Malawi
-
Centre Psychothérapique de NancyRecruitingDissociative DisorderFrance
-
ASST Fatebenefratelli SaccoActive, not recruiting
-
GlaxoSmithKlineThe PATH Malaria Vaccine Initiative (MVI)CompletedMalaria | Malaria VaccinesKenya, Ghana, Burkina Faso, Malawi, Senegal, Tanzania
-
Fakultas Kedokteran Universitas IndonesiaUnknownColorectal CancerIndonesia
-
Assistance Publique Hopitaux De MarseilleCompleted