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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02494089
Other study ID # SIM STRESS
Secondary ID
Status Completed
Phase N/A
First received May 29, 2015
Last updated July 19, 2016
Start date June 2015
Est. completion date July 2016

Study information

Verified date July 2016
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical 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.

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)).


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date July 2016
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- team members: nurses, auxiliary nurse, residents, doctors, students

Exclusion Criteria:

- non volunteers

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
distress analysis


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type Measure Description Time frame Safety issue
Primary psychologic distress analysis induced by in situ simulation auto-validated distress inventory: IESR-R STAI-A STAI-B GHQ-12 JSS 3 weeks No
Secondary Stress vulnerability to in situ simulation distress inventory: JSS STAI-A social questionary 3 weeks No
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