NCT02470130

Brief Summary

Resident in advanced medical training participated to high fidelity simulation education program in Lyon. Alternatively 1 or 2 resident act during a scenario while the others observe in a teletransmission closeby room. Debriefing follows the critical scenario in witch resident are involved. The investigators are testing the effects of five minute of conversational relaxation before the debriefing on the anxiety level and memorization of key points each scénario on participant and observer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable anxiety

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

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

May 20, 2015

Last Update Submit

July 5, 2016

Conditions

Anxiety

Keywords

simulationanxietydebriefingmemorization

Outcome Measures

Primary Outcomes (1)

  • memorization of the active scenario

    5 key points for the resolution of the scenario, 1 point per key points recalled by the participant, metrics from 0 to 5.

    3 month

Secondary Outcomes (4)

  • anxiety

    min 1

  • debriefing

    min 1

  • observing

    min 1

  • memorization of the passive scenario

    3 month

Study Arms (4)

relax actor

ACTIVE COMPARATOR

actor during simulation and relaxation before debriefing

Behavioral: relaxation

no relax actor

NO INTERVENTION

actor during simulation and no relaxation before debriefing

relax observer

ACTIVE COMPARATOR

observer during simulation and relaxation before debriefing

Behavioral: relaxation

no relax observer

NO INTERVENTION

observer during simulation and no relaxation before debriefing

Interventions

relaxationBEHAVIORAL

5 min of conversational relaxation red by one of the instructor between simulation and debriefing

relax actorrelax observer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • every resident going to a scheduled simulation session part of the normal education program of the residency.

You may not qualify if:

  • no consent, or consent deleted

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

    HCL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 20, 2015

First Posted

June 12, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 7, 2016

Record last verified: 2016-07

Locations

FR(1)