Relaxation Before Debriefing and Memorization in High Fidelity Simulation in Healthcare

Anxiety Clinical Trial

— RELAXSIMHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470130
• Other study ID #: CLESS 2014
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: July 5, 2016
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Claude Bernard University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety

Intervention

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

Locations

Country	Name	City	State
France	CLESS	Lyon	Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	anxiety	visual analog scale : metrics from 0 to 100 mm	min 1	No
Secondary	debriefing	score of quality of the debriefing questionnaire of 6 items quoted, total score from 25 to 175	min 1	No
Secondary	observing	visual analog scale : metrics from 0 to 100 mm	min 1	No
Secondary	memorization of the passive 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	No