NCT02922608

Brief Summary

High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants. The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their sleep affected before the simulation session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,150

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

September 30, 2016

Last Update Submit

January 23, 2018

Conditions

SleepAnxiety

Keywords

Education, Medical

Outcome Measures

Primary Outcomes (1)

  • modification of the sleeping Leeds test

    day 1

Secondary Outcomes (2)

  • incidence of sleep perturbations

    day 1

  • analysis of demographics and sleep perturbations

    day 1

Interventions

simulation practiceOTHER

simulation session

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents coming to simulation center for high fidelity simulation education program.

You may qualify if:

  • french talking residents coming to high fidelity simulation

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLESS

Lyon, Auvergne-Rhône-Alpes, 69007, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • jean-jacques lehot, PHD

    Cless

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 4, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

FR(1)