BurnoutNCT07437443
Burnout, Secondary Traumatic Stress and Inflammatory Biomarkers in ICU Healthcare Workers
An observational study of Burnout and Secondary Traumatic Stress, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burnout, Secondary Traumatic Stress, Occupational Stress
- What is being tested?
- Psychometric Assessment and Blood Sampling
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 10 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fethi Sekin City Hospital
Elâzığ, Elâzığ, 23100
About this study
Official title: 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.
- Conditions
- Burnout, Secondary Traumatic Stress, Occupational Stress, Inflammation, Critical Care Staff
- Being tested
- Psychometric Assessment and Blood Sampling
- Keywords
- Burnout, Secondary Traumatic Stress, Intensive Care Unit, Healthcare Workers, Interleukin-6, TNF-alpha
- Medical subject headings
- Burnout, Psychological, Compassion Fatigue, Occupational Stress, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric Assessment and Blood SamplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Psychometric Assessment and Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of assessment (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Feb 2026
- Primary completion1 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sait Fatih Öner, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437443
- Sponsor's protocol ID
- EFSH-ICU-STRESS-2026-22-35
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Burnout, Secondary Traumatic Stress, and Inflammatory Biomarkers in Intensive Care Unit Healthcare Workers
- ClinicalTrials.gov ID
- NCT07437443
- Acronym / sponsor ID
- EFSH-ICU-STRESS-2026-22-35
- Conditions
- Burnout, Secondary Traumatic Stress, Occupational Stress, Inflammation, Critical Care Staff
- Keywords
- Burnout, Secondary Traumatic Stress, Intensive Care Unit, Healthcare Workers, Interleukin-6, TNF-alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Healthcare Workers | – | Other: Psychometric Assessment and Blood SamplingHealthcare 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychometric Assessment and Blood SamplingAdministration of validated burnout and secondary traumatic stress questionnaires and collection of blood samples for inflammatory biomarker analysis. No therapeutic or clinical intervention is performed. | Other | ICU Healthcare Workers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout and Secondary Traumatic Stress, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Burnout Levels and Inflammatory Biomarkers (time frame: At the time of assessment (single time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.