Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02672072
Previous Study | Return to List | Next Study

Simulation-based Education for Managing Stress in ICU Nurses (SISTRESSREA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672072
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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


Condition or disease Intervention/treatment
Professional Stress Other: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team) Other: questionnaire to define the presence of job strain at 6 months Other: questionnaire to define the presence of job strain at 12 months

Layout table for study information
Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Simulation-based Education for Managing Stress in ICU Nurses
Actual Study Start Date : January 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : May 2018

Group/Cohort Intervention/treatment
Control group
5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study
Other: questionnaire to define the presence of job strain at 6 months
Other: questionnaire to define the presence of job strain at 12 months
Simulation group
5-day specific training with dedicated scenario done by an ICU expert simulation team
Other: Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)
Other: questionnaire to define the presence of job strain at 6 months
Other: questionnaire to define the presence of job strain at 12 months



Primary Outcome Measures :
  1. Presence of job stain evaluated by the French version of the Karasek scale [ Time Frame: 6 months ]
    Presence of job strain: psychological demand of work > 21 and decision latitude < 72


Secondary Outcome Measures :
  1. Stress evaluated by the Karasek scale [ Time Frame: enrollment and 1 year ]
    Karasek questionnaire

  2. Psychosocial risks (Copenhagen Psychosocial Questionnaire) [ Time Frame: enrollment, 6 months and one year ]
    French version of the COPSOQ (Copenhagen Psychosocial Questionnaire)

  3. Burnout (Maslach Burnout Inventory) [ Time Frame: enrollment, 6 months and one year ]
    French version of the Maslach Burnout Inventory

  4. Intent-to-leave (Number of enrolled nurses who leave the actual ICU) [ Time Frame: enrollment, 6 months and one year ]
    Number of enrolled nurses who leave the actual ICU

  5. Quality of life (visual analogic scale) [ Time Frame: enrollment, 6 months and one year ]
    visual analogic scale from 0 to 10



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672072


Locations
Layout table for location information
France
AP-HM
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: Urielle DESALBRES AP-HM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02672072     History of Changes
Other Study ID Numbers: 2015-04
RCAPHM15_0036 ( Other Identifier: APHM )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Occupational Stress
Occupational Diseases
Stress, Psychological
Behavioral Symptoms