RELAXSIMHF: Relaxation Before Debriefing and Memorization in High Fidelity Simulation in Healthcare

Sponsor

Claude Bernard University (Other)

Overall Status

Completed

CT.gov ID

NCT02470130

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: relaxation	N/A

Detailed Description

Resident in advanced medical training participated to high fidelity simulation education program in Lyon. This is part of a curriculum and each year they go throw a specific simulation session in groups of 3 to 8 residents with same specific thematic education goals. 3 to 4 differents scénario are run every simulation session during 4 to 5 hours, every day 2 similar session are run with 2 different groups of same level residents. Alternatively 1 or 2 resident act during a scenario while the others observe in a teletransmission 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. Relaxation is done reading a text outloud by an instructor before the debriefing. Each scenario is run in the morning and the afternoon and alternatively have relaxation or not. evaluation is done on participant of the scenario and resident observer of the situation. The Investigators ask participant for demographic data, anxiety scale test, multiple anxiety visual analogic scale. At the end of every scenario 5 clinical key point of teh scenario are exposed. At 3 month the investigators call back every participant to ask them to remember these 5 points for the scenario they were involved in and one of the other they observed.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Effect of a Debriefing Conversational Relaxation on Memorization of Critical Key Points in Resident High Fidelity Simulation Education Program

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: relax actor actor during simulation and relaxation before debriefing	Behavioral: relaxation 5 min of conversational relaxation red by one of the instructor between simulation and debriefing
No Intervention: no relax actor actor during simulation and no relaxation before debriefing
Active Comparator: relax observer observer during simulation and relaxation before debriefing	Behavioral: relaxation 5 min of conversational relaxation red by one of the instructor between simulation and debriefing
No Intervention: no relax observer observer during simulation and no relaxation before debriefing

Outcome Measures

Primary Outcome Measures

memorization of the active scenario [3 month]
5 key points for the resolution of the scenario, 1 point per key points recalled by the participant, metrics from 0 to 5.

Secondary Outcome Measures

anxiety [min 1]
visual analog scale : metrics from 0 to 100 mm
debriefing [min 1]
score of quality of the debriefing questionnaire of 6 items quoted, total score from 25 to 175
observing [min 1]
visual analog scale : metrics from 0 to 100 mm
memorization of the passive scenario [3 month]
5 key points for the resolution of the scenario, 1 point per key points recalled by the participant, metrics from 0 to 5.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

no consent, or consent deleted

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CLESS	Lyon	Rhône-Alpes	France	69007

Sponsors and Collaborators

Claude Bernard University

Investigators

Study Chair: jean jacques Lehot, PHD, HCL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lilot Marc, MD, Claude Bernard University

ClinicalTrials.gov Identifier:

NCT02470130

Other Study ID Numbers:

CLESS 2014

First Posted:

Jun 12, 2015

Last Update Posted:

Jul 7, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Lilot Marc, MD, Claude Bernard University

Study Results

No Results Posted as of Jul 7, 2016