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
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
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Marseille, França
- AP-HM
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Presence of job stain evaluated by the French version of the Karasek scale
Prazo: 6 months
|
Presence of job strain: psychological demand of work > 21 and decision latitude < 72
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Stress evaluated by the Karasek scale
Prazo: enrollment and 1 year
|
Karasek questionnaire
|
enrollment and 1 year
|
|
Psychosocial risks (Copenhagen Psychosocial Questionnaire)
Prazo: enrollment, 6 months and one year
|
French version of the COPSOQ (Copenhagen Psychosocial Questionnaire)
|
enrollment, 6 months and one year
|
|
Burnout (Maslach Burnout Inventory)
Prazo: 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)
Prazo: 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)
Prazo: enrollment, 6 months and one year
|
visual analogic scale from 0 to 10
|
enrollment, 6 months and one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Urielle DESALBRES, AP-HM
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2015-04
- RCAPHM15_0036 (Outro identificador: APHM)
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