NCT07437443

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

6 days

First QC Date

February 22, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

BurnoutSecondary Traumatic StressIntensive Care UnitHealthcare WorkersInterleukin-6TNF-alpha

Outcome Measures

Primary Outcomes (1)

  • Association Between Burnout Levels and Inflammatory Biomarkers

    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)

Study Arms (1)

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.

Other: Psychometric Assessment and Blood Sampling

Interventions

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.

ICU Healthcare Workers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of healthcare professionals working in intensive care units (anesthesia, internal medicine, and chest diseases ICUs) at Elazığ Fethi Sekin City Hospital. Participants include physicians, nurses, anesthesia technicians, and other healthcare staff who are actively involved in the care of critically ill patients. All participants are adults undergoing routine annual occupational health screening and voluntarily agree to participate in the study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burnout, PsychologicalCompassion FatigueOccupational StressInflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsOccupational DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

February 23, 2026

Primary Completion

March 1, 2026

Study Completion

March 10, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations