Effect of in Situ Simulation on Quality of Work Life and Multiprofessional Team Effectiveness in the Intensive Care Unit

NCT06944821 | Recruiting

• 1 other identifier: RECHMPL24_0497
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to the end of the follow up at 6 months

Secondary Outcomes (7)

• Burnout subscale of ProQOL-5

  From baseline to the end of the follow up at 6 months

• Vicarious trauma subscale of ProQOL

  From baseline to the end of the follow up at 6 months

• Karasek

  From baseline to the end of the follow up at 6 months

• WRQoL (QwOL)

  From baseline to the end of the follow up at 6 months

• Work-Life Balance scale questionnaire

  From baseline to the end of the follow up at 6 months

Study Arms (2)

In-situ stimulation

EXPERIMENTAL

Procedure: In-situ simulation; Other: Role-playing using a simulation scenario; Other: Questionnaires

Control

OTHER

Other: Role-playing using a simulation scenario; Other: Questionnaires

Interventions

In-situ simulation PROCEDURE

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

In-situ stimulation

Role-playing using a simulation scenario OTHER

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.

Control; In-situ stimulation

Questionnaires OTHER

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

Control; In-situ stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Departement of anesthesia cardio-thoracic and vascular resuscitation Arnaud de Vinelleuve Hospital CHU of Montpellier.

Montpellier, Occitanie, 34090, France

RECRUITING

University Hospital of Montpellier

Montpellier, France

NOT YET RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Céline PLOMB, Nurse

CONTACT

0033 467335958; c.plomb@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)