NCT02494089

Brief 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)).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

May 29, 2015

Last Update Submit

July 19, 2016

Conditions

Psychologic StressHeart Arrest

Keywords

in situ simulationin hospital cardiac arrestclinical auditeducationpatient simulation

Outcome Measures

Primary Outcomes (1)

  • psychologic distress analysis induced by in situ simulation

    auto-validated distress inventory: IESR-R STAI-A STAI-B GHQ-12 JSS

    3 weeks

Secondary Outcomes (1)

  • Stress vulnerability to in situ simulation

    3 weeks

Interventions

distress analysisOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

team members

You may qualify if:

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

You may not qualify if:

  • non volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress, PsychologicalHeart Arrest

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 29, 2015

First Posted

July 10, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Study Completion

July 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07