An interventional study of In-situ simulation and Role-playing using a simulation scenario in Quality of Work Life, Burn-out and Simulation, sponsored by University Hospital, Montpellier. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
The lack of specific, personalized training for intensive care workers can lead to a deterioration in quality of life at work, and can result in burnout, absenteeism or wanting to leave the service. The aim of this study is to assess the impact of in situ simulation on quality of work life and the effectiveness of multi-professional teamwork in intensive care.
Paramedics in intensive care are particularly exposed to the risk of burnout, which is multifactorial (psychologically and physically challenging environment, life-threatening emergency context, etc.). Personal assistance professions require a high level of compassion, leading to a positive feeling of compassionate satisfaction, i.e. the satisfaction of helping others. Compassion fatigue leads to a reduction in job satisfaction, culminating in burnout. Factors negatively influencing compassion satisfaction are the absence of specific and adapted training, or the lack of support from the hierarchy. Among the pedagogical tools available, in situ simulation could be used to respond to a specific and personalized training request from a care department. The study will be carried out in the cardio-thoracic intensive care unit at Montpellier University Hospital, comparing 2 groups to assess the effect of simulation on paramedics. Paramedics will be randomized into 2 groups, with stratification on diploma (nursing assistant or nurse): group A benefiting from a simulation program, and group B not benefiting from it during the study.
442 studies on the registry are indexed under Burnout, Psychological; 106 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 319 interventional studies indexed under Burnout, Psychological.
Browse Burnout, Psychological studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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Procedure: In-situ simulation · Other: Role-playing using a simulation scenario · Other: Questionnaires
Other: Role-playing using a simulation scenario · Other: Questionnaires
Each simulation session takes place over one day, with 4 scenarios recreating life-threatening emergency situations (cardiorespiratory arrest, hemorrhagic shock, etc.). Each scenario is designed to meet specific pedagogical objectives, which will be debriefed by simulation trainers: crisis resource management (communication, alerting, etc.) or organization of multi-professional teamwork
Team performance in critical situations, assessed during a simulation scenario for all participants. The assessment will be carried out blind by 1 examiner, trained in CRM (Crisis Resource Management) analysis in simulation and debriefing.
Quality of lige questionnaire Pro-QOL, Karasek questionnaire, Satisfaction questionnaire at work : WRQoL, Work Life Balance scale, Mayo Hight Team Performance scale will be completed at baseline and at 6 months
Subscale of compassion satisfaction of ProQOL-5 (Professional Quality of Life Scale version 5
The ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale Compassion Satisfaction is composed of 10 questions. A score ≤ 22 indicates a deterioration in compassion satisfaction.
Time frame: From baseline to the end of the follow up at 6 months
Burnout subscale of ProQOL-5
The ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale Burnout is composed of 10 questions. A score ≥42 indicates a hight burnout level
Time frame: From baseline to the end of the follow up at 6 months
Vicarious trauma subscale of ProQOL
The ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale " Vicarious Trauma " is composed of 10 questions. A score ≥42 indicates a hight vicarious trauma level
Time frame: From baseline to the end of the follow up at 6 months
Karasek
The Karasek self-questionnaire assess the "job strain ". It is composed of 3 susbscales : the psychological demand, the Decision latitude and the Social support at work. A decision-making latitude score \< 72 and a Psychological Demand score ≥ 21 is associated with a Job Strain
Time frame: From baseline to the end of the follow up at 6 months
WRQoL (QwOL)
The Work-related Quality of Life is composed of 23 questions. It evaluates 6 dimensions: the feeling of being involved in decisions (3 assertions), appreciation of work organization and general satisfaction (7), help with external demands (3), satisfaction with working conditions (3), satisfaction with the ability to do one's job (6) and stress at work (2). A higher score is associated to a highter quality of life at work.
Time frame: From baseline to the end of the follow up at 6 months
Work-Life Balance scale questionnaire
The Work-Life Balance scale assess the impact of work on personal quality of life. It is composed of 3 subscales about : Work interferes with personal life (WIPL), Personal interferes with work (PLIW), Satisfaction with quality of personal and work life (WPLE). A high score is associated with significant interference of work with private life
Time frame: From baseline to the end of the follow up at 6 months
Mayo High Performance Team Scale
The Mayo High Performance Team Scale is a standardized evaluation scale, designed to meet non-technical teaching objectives named CRM (Crisis Resource Management). This scale assess the effectiveness and performance of teams of emergency care workers
Time frame: From baseline to the end of the follow up at 6 months
Adverse event
Occurrence of adverse events or errors linked to a lack of interprofessional communication
Time frame: From baseline to the end of the follow up at 6 months
Plan to share: No
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University Hospital, Montpellier