Simulation-based Education for Managing Stress in ICU Nurses (SISTRESSREA)
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
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Marseille, France
- AP-HM
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- ICU nurses from adult ICUs with a professional experience in the actual ICU of at least 6 months and no decision to leave the ICU at the time of enrollment
Non inclusion Criteria:
- Less than 6 months of professional activity in the actual ICU at the time of enrollment
- Intent-to-leave in the next 6-month period
- Previous experience of this simulation program
- Pregnant women
Exclusion Criteria :
- ICU nurses who leave their city during the study period
- Pregnant women who miss their job during at least 4 weeks during the study period
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Control group
5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study
|
|
|
Simulation group
5-day specific training with dedicated scenario done by an ICU expert simulation team
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Presence of job stain evaluated by the French version of the Karasek scale
Délai: 6 months
|
Presence of job strain: psychological demand of work > 21 and decision latitude < 72
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Stress evaluated by the Karasek scale
Délai: enrollment and 1 year
|
Karasek questionnaire
|
enrollment and 1 year
|
|
Psychosocial risks (Copenhagen Psychosocial Questionnaire)
Délai: enrollment, 6 months and one year
|
French version of the COPSOQ (Copenhagen Psychosocial Questionnaire)
|
enrollment, 6 months and one year
|
|
Burnout (Maslach Burnout Inventory)
Délai: enrollment, 6 months and one year
|
French version of the Maslach Burnout Inventory
|
enrollment, 6 months and one year
|
|
Intent-to-leave (Number of enrolled nurses who leave the actual ICU)
Délai: enrollment, 6 months and one year
|
Number of enrolled nurses who leave the actual ICU
|
enrollment, 6 months and one year
|
|
Quality of life (visual analogic scale)
Délai: enrollment, 6 months and one year
|
visual analogic scale from 0 to 10
|
enrollment, 6 months and one year
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Urielle DESALBRES, AP-HM
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2015-04
- RCAPHM15_0036 (Autre identifiant: APHM)
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