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
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Marseille, Francia
- AP-HM
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Presence of job stain evaluated by the French version of the Karasek scale
Periodo de tiempo: 6 months
|
Presence of job strain: psychological demand of work > 21 and decision latitude < 72
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Stress evaluated by the Karasek scale
Periodo de tiempo: enrollment and 1 year
|
Karasek questionnaire
|
enrollment and 1 year
|
|
Psychosocial risks (Copenhagen Psychosocial Questionnaire)
Periodo de tiempo: enrollment, 6 months and one year
|
French version of the COPSOQ (Copenhagen Psychosocial Questionnaire)
|
enrollment, 6 months and one year
|
|
Burnout (Maslach Burnout Inventory)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: enrollment, 6 months and one year
|
visual analogic scale from 0 to 10
|
enrollment, 6 months and one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Urielle DESALBRES, AP-HM
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-04
- RCAPHM15_0036 (Otro identificador: APHM)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .