Psychologic StressSIMSTRESSNCT02494089
Analysis of the Stress Induced by in Situ Simulation
An observational study of Psychologic Stress and Heart Arrest, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Vulnerability to psychologic distress induced by in situ simulation. Objectives: Psychological evaluation at short and long term on working satisfaction, mental health, and acute stress after in situ simulation. Analysis of the stress vulnerability induced by simulation. Design: non interventional study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychologic Stress, Heart Arrest
- What is being tested?
- distress analysis
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2016
- 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: team members
Who may be able to join
- team members: nurses, auxiliary nurse, residents, doctors, students
Who cannot join
- non volunteers
About this study
Vulnerability to psychologic distress induced by in situ simulation.
Objectives: Psychological evaluation at short and long term on working satisfaction, mental health, and acute stress after in situ simulation. Analysis of the stress vulnerability induced by simulation.
Design: non interventional study.
Primary outcome: Psychologic distress analysis with validated psychologic distress inventory (Job Satisfaction Survey (JSS), General Health Quality (GHQ), Impact of Event Scale Revisited (IESR), State-Trait Anxiety Inventory-A (STAI-A), State-Trait Anxiety Inventory -B (STAI-B)).
- Conditions
- Psychologic Stress, Heart Arrest
- Being tested
- distress analysis
- Keywords
- in situ simulation, in hospital cardiac arrest, clinical audit, education, patient simulation
- Medical subject headings
- Stress, Psychological, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distress analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
psychologic distress analysis induced by in situ simulation
auto-validated distress inventory: IESR-R STAI-A STAI-B GHQ-12 JSS
Measured: 3 weeks
Secondary outcomes (1)
Stress vulnerability to in situ simulation
distress inventory: JSS STAI-A social questionary
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychologic StressStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannick BRUNIN, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494089
- Sponsor's protocol ID
- SIM STRESS
- Acronym
- SIMSTRESS
- Status last verified
- Jul 2016
- First submitted
- 29 May 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Stress Induced by in Situ Simulation
- ClinicalTrials.gov ID
- NCT02494089
- Acronym / sponsor ID
- SIMSTRESS / SIM STRESS
- Conditions
- Psychologic Stress, Heart Arrest
- Keywords
- in situ simulation, in hospital cardiac arrest, clinical audit, education, patient simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Jul 2015 (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.
Vulnerability to psychologic distress induced by in situ simulation.
Objectives: Psychological evaluation at short and long term on working satisfaction, mental health, and acute stress after in situ simulation. Analysis of the stress vulnerability induced by simulation.
Design: non interventional study.
Primary outcome: Psychologic distress analysis with validated psychologic distress inventory (Job Satisfaction Survey (JSS), General Health Quality (GHQ), Impact of Event Scale Revisited (IESR), State-Trait Anxiety Inventory-A (STAI-A), State-Trait Anxiety Inventory -B (STAI-B)).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- team members
Key inclusion criteria (1 listed)
- team members: nurses, auxiliary nurse, residents, doctors, students
Key exclusion criteria (1 listed)
- non volunteers
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 |
|---|---|---|
| distress analysis | Other | – |
Primary outcome
psychologic distress analysis induced by in situ simulation
Time frame: 3 weeks
auto-validated distress inventory: IESR-R STAI-A STAI-B GHQ-12 JSS
1 secondary outcome
Stress vulnerability to in situ simulation
Time frame: 3 weeks
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 20 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychologic Stress and Heart Arrest, run by Centre Hospitalier Universitaire de Besancon.
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 1 inclusion and 1 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
psychologic distress analysis induced by in situ simulation (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2016.