Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Simulation-based Education for Managing Stress in ICU Nurses
Brief Summary: 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


Options:
A: Arm Label: Control group; Type: N/A; Interventions: Other: questionnaire to define the presence of job strain at 6 months, Other: questionnaire to define the presence of job strain at 12 months | Arm Label: Simulation group; Type: N/A; Interventions: Other: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team), Other: questionnaire to define the presence of job strain at 6 months, Other: questionnaire to define the presence of job strain at 12 months | Intervention Type: OTHER; Name: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team); Assigned to Arm(s): Simulation group | Intervention Type: OTHER; Name: questionnaire to define the presence of job strain at 6 months; Assigned to Arm(s): Control group, Simulation group | Intervention Type: OTHER; Name: questionnaire to define the presence of job strain at 12 months; Assigned to Arm(s): Control group, Simulation group
B: Arm Label: Cohort 1; Type: OTHER; Interventions: Behavioral: Three Good Things, Behavioral: Gratitude, Behavioral: Random Acts of Kindess, Behavioral: Awe, Behavioral: 1 Good Chat | Arm Label: Cohort 2; Type: OTHER; Interventions: Behavioral: Three Good Things, Behavioral: Gratitude, Behavioral: Random Acts of Kindess, Behavioral: Awe, Behavioral: 1 Good Chat | Arm Label: Cohort 3 (July cohort) WISER 2.0; Type: EXPERIMENTAL; Interventions: Behavioral: Three Good Things, Behavioral: Gratitude, Behavioral: Random Acts of Kindess, Behavioral: Awe, Behavioral: 1 Good Chat | Intervention Type: BEHAVIORAL; Name: Three Good Things; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: Gratitude; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: Random Acts of Kindess; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: Awe; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: 1 Good Chat; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0
C: Arm Label: Visual Arts Group; Type: EXPERIMENTAL; Interventions: Behavioral: Visual Arts | Arm Label: Music Group; Type: EXPERIMENTAL; Interventions: Behavioral: Music | Arm Label: Dance/Movement Group; Type: EXPERIMENTAL; Interventions: Behavioral: Dance/Movement | Arm Label: Writing/Poetry Group; Type: EXPERIMENTAL; Interventions: Behavioral: Writing/Poetry | Arm Label: Control Group; Type: EXPERIMENTAL; Interventions: Behavioral: Control | Intervention Type: BEHAVIORAL; Name: Visual Arts; Assigned to Arm(s): Visual Arts Group | Intervention Type: BEHAVIORAL; Name: Music; Assigned to Arm(s): Music Group | Intervention Type: BEHAVIORAL; Name: Dance/Movement; Assigned to Arm(s): Dance/Movement Group | Intervention Type: BEHAVIORAL; Name: Writing/Poetry; Assigned to Arm(s): Writing/Poetry Group | Intervention Type: BEHAVIORAL; Name: Control; Assigned to Arm(s): Control Group
D: Arm Label: MINDI mindfulness curriculum; Type: EXPERIMENTAL; Interventions: Other: MINDI mindfulness curriculum | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: MINDI mindfulness curriculum; Assigned to Arm(s): MINDI mindfulness curriculum | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control

Answer: A