Analysis of the Stress Induced by in Situ Simulation | NCT02494089

Studies
Analysis of the Stress Induced by in Situ Simulation

NCT02494089

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Jul 20, 2016Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

Psychologic Stress
Heart Arrest

Interventions

distress analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Jul 2016Actual

First Submitted Date

May 29, 2015

First Submission Date that Met QC Criteria

Jul 7, 2015

First Posted Date

Jul 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2016

Last Update Posted Date

Jul 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yannick BRUNIN, Doctor, Centre Hospitalier Universitaire de BesanconPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de BesanconOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Name	Type	Description	Arm Group Labels	Other Names
distress analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Stress vulnerability to in situ simulation	distress inventory: JSS STAI-A social questionary	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

non volunteers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

team members

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological
D006323	Heart Arrest

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided