AnxietyRELAXSIMHFNCT02470130
Relaxation Before Debriefing and Memorization in High Fidelity Simulation in Healthcare
A study testing relaxation in people with Anxiety, run by Claude Bernard University at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- every resident going to a scheduled simulation session part of the normal education program of the residency.
Who cannot join
- no consent, or consent deleted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- relaxation
- Keywords
- simulation, anxiety, debriefing, memorization
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxationBehavioural
5 min of conversational relaxation red by one of the instructor between simulation and debriefing
| Study group | Role | What they receive |
|---|---|---|
| relax actor | Active comparator | actor during simulation and relaxation before debriefing Receives: 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 Receives: Behavioral: relaxation |
| no relax observer | No intervention | observer during simulation and no relaxation before debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (4)
anxiety
visual analog scale : metrics from 0 to 100 mm
Measured: min 1
debriefing
score of quality of the debriefing questionnaire of 6 items quoted, total score from 25 to 175
Measured: min 1
observing
visual analog scale : metrics from 0 to 100 mm
Measured: min 1
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.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- jean jacques Lehot, PHD, Study chair, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470130
- Sponsor's protocol ID
- CLESS 2014
- Acronym
- RELAXSIMHF
- Status last verified
- Jul 2016
- First submitted
- 20 May 2015
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Debriefing Conversational Relaxation on Memorization of Critical Key Points in Resident High Fidelity Simulation Education Program
- ClinicalTrials.gov ID
- NCT02470130
- Acronym / sponsor ID
- RELAXSIMHF / CLESS 2014
- Conditions
- Anxiety
- Keywords
- simulation, anxiety, debriefing, memorization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| relax actor | Active comparator | Behavioral: relaxationactor during simulation and relaxation before debriefing |
| no relax actor | No intervention | –actor during simulation and no relaxation before debriefing |
| relax observer | Active comparator | Behavioral: relaxationobserver during simulation and relaxation before debriefing |
| no relax observer | No intervention | –observer during simulation and no relaxation before debriefing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- every resident going to a scheduled simulation session part of the normal education program of the residency.
Key exclusion criteria (1 listed)
- no consent, or consent deleted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation5 min of conversational relaxation red by one of the instructor between simulation and debriefing | Behavioural | relax actor, relax observer |
Primary outcome
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.
4 secondary outcomes
anxiety
Time frame: min 1
debriefing
Time frame: min 1
observing
Time frame: min 1
memorization of the passive scenario
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean jacques Lehot, PHD study chair
HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation in people with Anxiety, run by Claude Bernard University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
memorization of the active scenario (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.