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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06302764
Other study ID # WZiKS.4.1.2023.2
Secondary ID WZiKS.4.1.2023
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source Jagiellonian University
Contact Krystyna Golonka, Prof
Phone 0048-12-663-24-15
Email krystyna.golonka@uj.edu.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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: 1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms. 2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams. 3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols. 4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology. 5. Formation of an interdisciplinary international research team.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date June 30, 2024
Est. primary completion date April 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - completed medical studies or emergency medical course - assistance in life-threatening conditions Exclusion Criteria: - Intellectual disability - Inability to self-complete the research questionnaires

Study Design


Intervention

Diagnostic Test:
Qualitative & Quantitative Research
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).

Locations

Country Name City State
Poland Institute of Applied Psychology, Jagiellonian University in Krakow, Poland Krakow Malopolska
Portugal University of Coimbra Coimbra
Ukraine Bogomolets National Medical University Kyiv

Sponsors (1)

Lead Sponsor Collaborator
Jagiellonian University

Countries where clinical trial is conducted

Poland,  Portugal,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Focused Interview Interviews pertaining to physical injury risk, psychosocial factors, and personal indicators October, 2023 until November, 2023
Primary 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. December, 2023 until March, 2024
Primary 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. December, 2023 until March, 2024
Primary 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. December, 2023 until March, 2024
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