Simulation-based Education for Managing Stress in ICU Nurses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Professional Stress

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study

questionnaire to define the presence of job strain at 6 months

Intervention Type OTHER

questionnaire to define the presence of job strain at 12 months

Intervention Type OTHER

Simulation group

5-day specific training with dedicated scenario done by an ICU expert simulation team

Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)

Intervention Type OTHER

questionnaire to define the presence of job strain at 6 months

Intervention Type OTHER

questionnaire to define the presence of job strain at 12 months

Intervention Type OTHER

Interventions

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Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)

Intervention Type OTHER

questionnaire to define the presence of job strain at 6 months

Intervention Type OTHER

questionnaire to define the presence of job strain at 12 months

Intervention Type OTHER

Eligibility Criteria

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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

* 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