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Simulation-based Education for Managing Stress in ICU Nurses

Simulation-based Education for Managing Stress in ICU Nurses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02672072
Acronym
SISTRESSREA
Enrollment
198
Registered
2016-02-03
Start date
2016-01-31
Completion date
2018-05-31
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Professional Stress

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

Interventions

OTHERSimulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)
OTHERquestionnaire to define the presence of job strain at 6 months
OTHERquestionnaire to define the presence of job strain at 12 months

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of job stain evaluated by the French version of the Karasek scale6 monthsPresence of job strain: psychological demand of work \> 21 and decision latitude \< 72

Secondary

MeasureTime frameDescription
Stress evaluated by the Karasek scaleenrollment and 1 yearKarasek questionnaire
Psychosocial risks (Copenhagen Psychosocial Questionnaire)enrollment, 6 months and one yearFrench version of the COPSOQ (Copenhagen Psychosocial Questionnaire)
Burnout (Maslach Burnout Inventory)enrollment, 6 months and one yearFrench version of the Maslach Burnout Inventory
Intent-to-leave (Number of enrolled nurses who leave the actual ICU)enrollment, 6 months and one yearNumber of enrolled nurses who leave the actual ICU
Quality of life (visual analogic scale)enrollment, 6 months and one yearvisual analogic scale from 0 to 10

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026