Clinical trial NCT06944821: Effect of in Situ Simulation on Quality of Work Life and Multiprofessional Team Effectiveness in the Intensive Care Unit
Official title: Effect of in Situ Simulation on Quality of Work Life and Multiprofessional Team Effectiveness in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quality of Work Life
Burn-out
Simulation
Keywords: In-situ simulation
Intensive care
Stress
Quality of working life
Quality of care
Performance
Caregivers
Teamwork
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Paramedical staff (nurse and nursing assistant) in the cardiothoracic intensive care unit at Montpellier University Hospital.
* Acceptance of being filmed for direct video transcription during the intervention

Exclusion Criteria:

* Refusal of consent or inability to give consent (guardianship, curatorship)
* Paramedics intending to leave the department before the end of the study.
* Not affiliated to a French social security scheme or not a beneficiary of such a scheme

Primary outcomes:
measure: Subscale of compassion satisfaction of ProQOL-5 (Professional Quality of Life Scale version 5
timeFrame: From baseline to the end of the follow up at 6 months
Secondary outcomes:
measure: Burnout subscale of ProQOL-5
timeFrame: From baseline to the end of the follow up at 6 months
measure: Vicarious trauma subscale of ProQOL
timeFrame: From baseline to the end of the follow up at 6 months
measure: Karasek
timeFrame: From baseline to the end of the follow up at 6 months
measure: WRQoL (QwOL)
timeFrame: From baseline to the end of the follow up at 6 months
measure: Work-Life Balance scale questionnaire
timeFrame: From baseline to the end of the follow up at 6 months
measure: Mayo High Performance Team Scale
timeFrame: From baseline to the end of the follow up at 6 months
measure: Adverse event
timeFrame: From baseline to the end of the follow up at 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement of anesthesia cardio-thoracic and vascular resuscitation Arnaud de Vinelleuve Hospital CHU of Montpellier.
state: Occitanie
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References: