- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470130
Relaxation Before Debriefing and Memorization in High Fidelity Simulation in Healthcare (RELAXSIMHF)
July 5, 2016 updated by: Lilot Marc, Claude Bernard University
Effect of a Debriefing Conversational Relaxation on Memorization of Critical Key Points in Resident High Fidelity Simulation Education Program
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhône-Alpes
-
Lyon, Rhône-Alpes, France, 69007
- CLESS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: relax actor
actor during simulation and relaxation before debriefing
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
memorization of the active scenario
Time Frame: 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.
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anxiety
Time Frame: min 1
|
visual analog scale : metrics from 0 to 100 mm
|
min 1
|
debriefing
Time Frame: min 1
|
score of quality of the debriefing questionnaire of 6 items quoted, total score from 25 to 175
|
min 1
|
observing
Time Frame: min 1
|
visual analog scale : metrics from 0 to 100 mm
|
min 1
|
memorization of the passive scenario
Time Frame: 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.
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: jean jacques Lehot, PHD, HCL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
May 20, 2015
First Submitted That Met QC Criteria
June 9, 2015
First Posted (Estimate)
June 12, 2015
Study Record Updates
Last Update Posted (Estimate)
July 7, 2016
Last Update Submitted That Met QC Criteria
July 5, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CLESS 2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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