Professional StressSISTRESSREANCT02672072
Simulation-based Education for Managing Stress in ICU Nurses
An observational study of Professional Stress, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Professional Stress
- What is being tested?
- Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team), questionnaire to define the presence of job strain at 6 months and questionnaire to define the presence of job strain at 12 months
- How many people
- 198 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
- 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
Read more
- 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
- 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
- Conditions
- Professional Stress
- Being tested
- Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team), questionnaire to define the presence of job strain at 6 months, questionnaire to define the presence of job strain at 12 months
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 monthsOther
questionnaire to define the presence of job strain at 12 monthsOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | 5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of job stain evaluated by the French version of the Karasek scale
Presence of job strain: psychological demand of work > 21 and decision latitude < 72
Measured: 6 months
Secondary outcomes (5)
Stress evaluated by the Karasek scale
Karasek questionnaire
Measured: enrollment and 1 year
Psychosocial risks (Copenhagen Psychosocial Questionnaire)
French version of the COPSOQ (Copenhagen Psychosocial Questionnaire)
Measured: enrollment, 6 months and one year
Burnout (Maslach Burnout Inventory)
French version of the Maslach Burnout Inventory
Measured: enrollment, 6 months and one year
Intent-to-leave (Number of enrolled nurses who leave the actual ICU)
Number of enrolled nurses who leave the actual ICU
Measured: enrollment, 6 months and one year
Quality of life (visual analogic scale)
visual analogic scale from 0 to 10
Measured: enrollment, 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Professional StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672072
- Sponsor's protocol ID
- 2015-04
- Other IDs
- RCAPHM15_0036
- Acronym
- SISTRESSREA
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2016
- Last updated
- 13 Oct 2026
- Results posted
- No
Publications
El Khamali R, Mouaci A, Valera S, Cano-Chervel M, Pinglis C, Sanz C, Allal A, Attard V, Malardier J, Delfino M, D'Anna F, Rostini P, Aguilard S, Berthias K, Cresta B, Iride F, Reynaud V, Suard J, Syja W, Vankiersbilck C, Chevalier N, Inthavong K, Forel JM, Baumstarck K, Papazian L; SISTRESSREA Study Group. Effects of a Multimodal Program Including Simulation on Job Strain Among Nurses Working in Intensive Care Units: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1988-1997. doi: 10.1001/jama.2018.14284.
PubMed 30357264
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Education for Managing Stress in ICU Nurses
- ClinicalTrials.gov ID
- NCT02672072
- Acronym / sponsor ID
- SISTRESSREA / 2015-04
- Conditions
- Professional Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: questionnaire to define the presence of job strain at 6 months, Other: questionnaire to define the presence of job strain at 12 months5-day specific training with dedicated scenario done by an ICU expert simulation team after the period of the study |
| Simulation group | – | 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 months5-day specific training with dedicated scenario done by an ICU expert simulation team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team) | Other | Simulation group |
| questionnaire to define the presence of job strain at 6 months | Other | Control group, Simulation group |
| questionnaire to define the presence of job strain at 12 months | Other | Control group, Simulation group |
Primary outcome
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
5 secondary outcomes
Stress evaluated by the Karasek scale
Time frame: enrollment and 1 year
Psychosocial risks (Copenhagen Psychosocial Questionnaire)
Time frame: enrollment, 6 months and one year
Burnout (Maslach Burnout Inventory)
Time frame: enrollment, 6 months and one year
Intent-to-leave (Number of enrolled nurses who leave the actual ICU)
Time frame: enrollment, 6 months and one year
Quality of life (visual analogic scale)
Time frame: enrollment, 6 months and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Results publication: PubMed 30357264El Khamali R, Mouaci A, Valera S, Cano-Chervel M, Pinglis C, Sanz C, Allal A, Attard V, Malardier J, Delfino M, D'Anna F, Rostini P, Aguilard S, Berthias K, Cresta B, Iride F, Reynaud V, Suard J, Syja W, Vankiersbilck C, Chevalier N, Inthavong K, Forel JM, Baumstarck K, Papazian L; SISTRESSREA Study Group. Effects of a Multimodal Program Including Simulation on Job Strain Among Nurses Working in Intensive Care Units: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1988-1997. doi: 10.1001/jama.2018.14284.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Professional Stress, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of job stain evaluated by the French version of the Karasek scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02672072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.