Professional Stress Clinical Trial
Official title:
Simulation-based Education for Managing Stress in ICU Nurses
I. Main outcome Decrease of the stress evaluated 6 months after training. Stress is defined
as the presence of job strain as defined by Karasek.
II. Main secondary outcomes
- ICU nurses stress at one year
- Burnout
- Intent-to-leave the ICU
- Quality of life
III. Design
Prospective, randomized, open study comparing 2 groups of ICU nurses:
Simulation group and Control group
Nurses from 9 different adult ICUs will be included. Stratification by ICU will be done (to
take into account differences between the ICUs regarding organization, activity, patients…).
This study is observational because nurses can participate to this training when they want.
The fact that nurses are in control group delays their participation to this training but
does not forbid them to particpate. The nurses from control group will participate to
training at the end of study.
IV. Specific measures Control group: none
Simulation group: 5-day specific training with dedicated scenario done by an ICU expert
simulation team
V. Study duration 48 months
VI. Ethical aspects - Reglementary concerns
- Study accepted by the Comité Consultatif sur le Traitement de l'Information en matière
de Recherche dans le domaine de la Santé (CCTIRS) and by the Commission Nationale de
l'Informatique et des Libertés (CNIL)
- Information to the participants prior inclusion
VII. Study population Job strain evaluated in a French study was 59% . The same rate was
observed in a survey done in our institution (Assistance Publique Hôpitaux de Marseille). We
therefore hypothesized that the intervention (simulation) should be able to reduce the job
strain from 59% to 45% of the participants. With a power of 80% and a risk a of 5%, this
study needs to include 185 patients per arm. To take into account few participants who will
not complete the study, we aimed to include a total of 400 ICU nurses.
VIII Results An interim analysis will be performed after 200 inclusions
n/a
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