Simulation-based Education for Managing Stress in ICU Nurses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Presence of job stain evaluated by the French version of the Karasek scale
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Presence of job stain evaluated by the French version of the Karasek scale
时间窗: 6 months
Presence of job strain: psychological demand of work \> 21 and decision latitude \< 72
次要结局
- Intent-to-leave (Number of enrolled nurses who leave the actual ICU)(enrollment, 6 months and one year)
- Quality of life (visual analogic scale)(enrollment, 6 months and one year)
- Stress evaluated by the Karasek scale(enrollment and 1 year)
- Psychosocial risks (Copenhagen Psychosocial Questionnaire)(enrollment, 6 months and one year)
- Burnout (Maslach Burnout Inventory)(enrollment, 6 months and one year)