StressNCT06302764
Emergency Medical Staff Workload Analysis
An observational study of Stress and Work Related Stress, run by Jagiellonian University at 3 sites in 3 countries.
Trial summary
The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Work Related Stress, PTSD
- What is being tested?
- Qualitative & Quantitative Research
- How many people
- 400 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Oct 2023to 30 Jun 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical staff involved in treating life-threatening conditions
Who may be able to join
- completed medical studies or emergency medical course
- assistance in life-threatening conditions
Who cannot join
- Intellectual disability
- Inability to self-complete the research questionnaires
Trial locations and contacts
3 sites in 3 countries.
Katarzyna Sitnik-Warchulska, PhD contact
3 sites in 3 countries
Poland1 site, 1 recruiting
- Recruiting
Institute of Applied Psychology, Jagiellonian University in Krakow, Poland
Krakow, Małopolska, 30-348
Krystyna Golonka, Prof, krystyna.golonka@uj.edu.pl
Katarzyna Sitnik-Warchulska, PhD, katarzyna.sitnik-warchulska@uj.edu.pl
Portugal1 site, 1 recruiting
- Recruiting
University of Coimbra
Coimbra
João Ferreira, PhD, naquelepordosol@gmail.com
João Ferreira, PhD
Ukraine1 site, 1 recruiting
- Recruiting
Bogomolets National Medical University
Kyiv
Sergii Tukaiev, PhD, tsv.serg.69@gmail.com
Borys Palamar, Prof, palamar.bi@ukr.net
About this study
Official title: Analysis of the Occupational Workload of Doctors and Medical Staff Involved in Emergency and Life-threatening Situations
The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:
- Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.
- Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.
- Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.
- Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.
- Formation of an interdisciplinary international research team.
Read the detailed description
Background: Data on the impact of workloads indicate that emergency medical personnel exposed to sudden threats to health or life are particularly vulnerable to the consequences of occupational stress. Symptoms of Post-Traumatic Stress Disorder (PTSD) within this professional group significantly surpass the rates found in the general population. Traumatic experiences encountered by medical staff may lead to a substantial decline in their mental health, as well as in their social and professional functioning.
Participants: Several hundred medical doctors and emergency medical personnel from Poland, Ukraine, Portugal and Spain.
Research Methodology: Analysis of data collected through focused interviews, psychological scales, and questionnaires pertaining to burnout, stress, and mental health conditions.
- Conditions
- Stress, Work Related Stress, PTSD, Mental Stress, Medical Emergencies
- Being tested
- Qualitative & Quantitative Research
- Keywords
- stress, work-related stress, trauma, PTSD, medical personnel
- Medical subject headings
- Occupational Stress, Stress Disorders, Post-Traumatic, Stress, Psychological, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative & Quantitative ResearchDiagnostic test
- Focused interviews - conducted by members of the appointed research team to recognize the issues faced by emergency medical staff in Poland, Ukraine, Portugal, and Spain with the aim of preparing the measurement framework.
- Online questionnaire surveys - conducted using the Qualtrics platform (available in different, language versions - Polish, Ukrainian, Portuguese, and Spanish).
| Study group | Role | What they receive |
|---|---|---|
| Polish Medical Staff | Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions Receives: Diagnostic Test: Qualitative & Quantitative Research | |
| Ukrainian Medical Staff | Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions Receives: Diagnostic Test: Qualitative & Quantitative Research | |
| Portuguese Medical Staff | Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions Receives: Diagnostic Test: Qualitative & Quantitative Research | |
| Spanish Medical Staff | Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions Receives: Diagnostic Test: Qualitative & Quantitative Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focused Interview
Interviews pertaining to physical injury risk, psychosocial factors, and personal indicators
Measured: October, 2023 until November, 2023
Posttraumatic Stress Disorder Checklist (PCL-5)
Posttraumatic Stress Disorder Checklist - 20-item, self-report measure to assess the symptoms of posttraumatic stress disorder. Items are rated on 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely). A general score ranges from 0 to 80 with a higher score indicating a higher symptoms of posttraumatic stress disorder.
Measured: December, 2023 until March, 2024
Patient Health Questionnaire (PHQ-9)
Patient Health Questionnaire - 9-item, self-report measure to assess the severity of depression. Items are rated on 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A general score ranges from 0 to 27 with a higher score indicating a higher depressive symptom severity.
Measured: December, 2023 until March, 2024
Depersonalization Mechanism Scale (DMS)
Depersonalization Mechanism Scale - a 20-item, self-report measure to assess the tendency to depersonalization. Items are rated on 5-point Likert scale, ranging from 0 (never) to 4 (very often). A general score ranges from 0 to 80 with a higher score indicating a higher tendency to depersonalization.
Measured: December, 2023 until March, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Oct 2023
- Primary completion20 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystyna Golonka, Jagiellonian University
- Investigators
- Krystyna Golonka, Prof, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302764
- Sponsor's protocol ID
- WZiKS.4.1.2023.2
- Other IDs
- WZiKS.4.1.2023
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Occupational Workload of Doctors and Medical Staff Involved in Emergency and Life-threatening Situations
- ClinicalTrials.gov ID
- NCT06302764
- Acronym / sponsor ID
- WZiKS.4.1.2023.2
- Conditions
- Stress, Work Related Stress, PTSD, Mental Stress, Medical Emergencies
- Keywords
- stress, work-related stress, trauma, PTSD, medical personnel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:
- Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.
- Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.
- Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.
- Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.
- Formation of an interdisciplinary international research team.
Detailed description
Background: Data on the impact of workloads indicate that emergency medical personnel exposed to sudden threats to health or life are particularly vulnerable to the consequences of occupational stress. Symptoms of Post-Traumatic Stress Disorder (PTSD) within this professional group significantly surpass the rates found in the general population. Traumatic experiences encountered by medical staff may lead to a substantial decline in their mental health, as well as in their social and professional functioning.
Participants: Several hundred medical doctors and emergency medical personnel from Poland, Ukraine, Portugal and Spain.
Research Methodology: Analysis of data collected through focused interviews, psychological scales, and questionnaires pertaining to burnout, stress, and mental health conditions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polish Medical Staff | – | Diagnostic Test: Qualitative & Quantitative ResearchMedical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions |
| Ukrainian Medical Staff | – | Diagnostic Test: Qualitative & Quantitative ResearchMedical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions |
| Portuguese Medical Staff | – | Diagnostic Test: Qualitative & Quantitative ResearchMedical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions |
| Spanish Medical Staff | – | Diagnostic Test: Qualitative & Quantitative ResearchMedical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical staff involved in treating life-threatening conditions
Key inclusion criteria (2 listed)
- completed medical studies or emergency medical course
- assistance in life-threatening conditions
Key exclusion criteria (2 listed)
- Intellectual disability
- Inability to self-complete the research questionnaires
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 |
|---|---|---|
| Qualitative & Quantitative Research1. Focused interviews - conducted by members of the appointed research team to recognize the issues faced by emergency medical staff in Poland, Ukraine, Portugal, and Spain with the aim of preparing the measurement framework. 2. Online questionnaire surveys - conducted using the Qualtrics platform (available in different, language versions - Polish, Ukrainian, Portuguese, and Spanish). | Diagnostic test | Polish Medical Staff, Portuguese Medical Staff, Spanish Medical Staff, Ukrainian Medical Staff |
Primary outcome
Focused Interview
Time frame: October, 2023 until November, 2023
Interviews pertaining to physical injury risk, psychosocial factors, and personal indicators
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: December, 2023 until March, 2024
Posttraumatic Stress Disorder Checklist - 20-item, self-report measure to assess the symptoms of posttraumatic stress disorder. Items are rated on 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely). A general score ranges from 0 to 80 with a higher score indicating a higher symptoms of posttraumatic stress disorder.
Patient Health Questionnaire (PHQ-9)
Time frame: December, 2023 until March, 2024
Patient Health Questionnaire - 9-item, self-report measure to assess the severity of depression. Items are rated on 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A general score ranges from 0 to 27 with a higher score indicating a higher depressive symptom severity.
Depersonalization Mechanism Scale (DMS)
Time frame: December, 2023 until March, 2024
Depersonalization Mechanism Scale - a 20-item, self-report measure to assess the tendency to depersonalization. Items are rated on 5-point Likert scale, ranging from 0 (never) to 4 (very often). A general score ranges from 0 to 80 with a higher score indicating a higher tendency to depersonalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Katarzyna Sitnik-Warchulska, PhD contact
Krystyna Golonka, Prof principal investigator
Jagiellonian University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Work Related Stress, run by Jagiellonian University at 3 sites in 3 countries.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Portugal, Ukraine. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krystyna Golonka, Prof (0048-12-663-24-15, krystyna.golonka@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focused Interview (time frame: October, 2023 until November, 2023). The study lists 4 primary outcomes in all. 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 16 Apr 2024.