Medical EducationNCT07183618
Impact of Mental Training on the Stress of Anaesthesiology Residents Before Performing Obstetrical Epidural Analgesia
A study testing Mental training group in people with Medical Education and Resident Education, run by University Hospital, Rouen at 1 site in France.
Trial summary
Anaesthetists are trained from the beginning of their residency to perform high-risk procedures, often in high-stress environments, that can adversely affect both their technical and non-technical performance. Effective stress management is therefore essential, particularly before executing technical procedures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Resident Education, Anesthesia
- What is being tested?
- Mental training group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2024to 28 Feb 2024
- 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
Inclusion Criteria: Eligible subjects for this study were anaesthesia and intensive care residents enrolled at the Faculty of Medicine and Pharmacy in Rouen. Residents were eligible if they were in the early stages of training (second and third years of residency) and had previously performed lumbar epidural anaesthesia multiple times in a maternity setting.
Exclusion Criteria: Exclusion criteria included first-year residents, as not all had performed obstetric lumbar epidural anaesthesia at the time of the study, and senior residents (fourth and fifth years).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mental Training on the Stress of Anaesthesiology Residents Before Performing Obstetrical Epidural Analgesia: a Prospective Randomized Educational Trial
Anaesthetists are trained from the beginning of their residency to perform high-risk procedures, often in high-stress environments, that can adversely affect both their technical and non-technical performance. Effective stress management is therefore essential, particularly before executing technical procedures. Recently, mental training has been introduced in the education of surgical residents to enhance performance under pressure. This study aimed to assess, using simulation, the impact of mental preparation on stress levels among anaesthesia residents before performing obstetric epidural analgesia.
Read the detailed description
Residents were randomly assigned to either a "Control" group or a "Mental Training" group, the latter undergoing a mental preparation session before performing lumbar epidural anaesthesia. Randomisation was performed in blocks of eight by an external party and stratified by training year (second or third) and gender. Residents were informed they would be participating in a training session involving anaesthetic practice on a low-fidelity simulator.
On the day of the simulation, residents were individually welcomed in a briefing room by an anaesthetist specialised in mental preparation. Group assignment was revealed from a sealed envelope and residents were informed that the simulation would involve acting as the on-call anaesthesia resident in a maternity ward. The scenario began with a call from a midwife requesting an epidural placement for a laboring patient. Depending on their assigned group, residents either received a mental preparation session or proceeded without it. Both groups participated in a ten-minute briefing session.
- Being tested
- Mental training group
- Keywords
- anesthesia residency, mental training, obstetrical epidural anesthesia, medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental training groupProcedure or surgery
Mental Training Group: Residents in the "Mental Training" group received a mental preparation session led by an anaesthesia physician qualified in medical pedagogy. Inspired by the "Breathe, Talk, See, Focus" procedure
| Study group | Role | What they receive |
|---|---|---|
| Control group (no mental training) | No intervention | Residents in the control group did not undergo any mental training prior to performing epidural placement. |
| Mental training group | Experimental | Mental Training Group: Residents in the "Mental Training" group received a mental preparation session led by an anaesthesia physician qualified in medical pedagogy. Inspired by the "Breathe, Talk, See, Focus" procedure Receives: Procedure: Mental training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the stress levels before and after performing obstetric epidural anaesthesia between residents who received mental preparation and those who did not.
Thestress level was evaluated using the State-Trait Anxiety Inventory 6 (STAI-6) score
Measured: Immediately after the simulation
Secondary outcomes (4)
Technical performance evaluation
Technical performance was assessed with a validated checklist
Measured: During the simulation
Non-technical skills evaluation
Non-technical skills was measured by the Anaesthetists' Non-Technical Skills (ANTS) score
Measured: During the simulation
Mental imagery abilities evaluation
Mental imagery abilities was assessed via the Mental Imagery Questionnaire
Measured: Immediatly after the simulation
Residents' satisfaction score
Satisfaction score ranging from 0 to 10
Measured: Immediatly after the simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start7 Feb 2024
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Residents were randomly assigned to either a "Control" group or a "Mental Training" group, the latter undergoing a mental preparation session before performing lumbar epidural anaesthesia. Randomisation was performed in blocks of eight by an external party and stratified by training year (second or third) and gender. Residents were informed they would be participating in a training session involving anaesthetic practice on a low-fidelity simulator. On the day of the simulation, residents were individually welcomed in a briefing room by an anaesthetist specialised in mental preparation. Group assignment was revealed from a sealed envelope and residents were informed that the simulation would involve acting as the on-call anaesthesia resident in a maternity ward. The scenario began with a call from a midwife requesting an epidural placement for a laboring patient. Depending on their assigned group, residents either received a mental preparation session or proceeded without it.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jean.selim, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183618
- Sponsor's protocol ID
- E2024-05
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fluteau L, Bourdon-Castel S, Kallout J, Lefevre-Scelles A, Sibert L, Besnier E, Clavier T, Compere V, Selim J. Impact of Mental Training on the stress of anaesthesiology residents before performing obstetrical epidural analgesia: A prospective randomised educational trial. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101675. doi: 10.1016/j.accpm.2025.101675. Epub 2025 Nov 15.
PubMed 41248877
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mental Training on the Stress of Anaesthesiology Residents Before Performing Obstetrical Epidural Analgesia: a Prospective Randomized Educational Trial
- ClinicalTrials.gov ID
- NCT07183618
- Acronym / sponsor ID
- E2024-05
- Keywords
- anesthesia residency, mental training, obstetrical epidural anesthesia, medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 19 Sep 2025 (actual)
- 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.
Anaesthetists are trained from the beginning of their residency to perform high-risk procedures, often in high-stress environments, that can adversely affect both their technical and non-technical performance. Effective stress management is therefore essential, particularly before executing technical procedures. Recently, mental training has been introduced in the education of surgical residents to enhance performance under pressure. This study aimed to assess, using simulation, the impact of mental preparation on stress levels among anaesthesia residents before performing obstetric epidural analgesia.
Detailed description
Residents were randomly assigned to either a "Control" group or a "Mental Training" group, the latter undergoing a mental preparation session before performing lumbar epidural anaesthesia. Randomisation was performed in blocks of eight by an external party and stratified by training year (second or third) and gender. Residents were informed they would be participating in a training session involving anaesthetic practice on a low-fidelity simulator.
On the day of the simulation, residents were individually welcomed in a briefing room by an anaesthetist specialised in mental preparation. Group assignment was revealed from a sealed envelope and residents were informed that the simulation would involve acting as the on-call anaesthesia resident in a maternity ward. The scenario began with a call from a midwife requesting an epidural placement for a laboring patient. Depending on their assigned group, residents either received a mental preparation session or proceeded without it. Both groups participated in a ten-minute briefing session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Residents were randomly assigned to either a "Control" group or a "Mental Training" group, the latter undergoing a mental preparation session before performing lumbar epidural anaesthesia. Randomisation was performed in blocks of eight by an external party and stratified by training year (second or third) and gender. Residents were informed they would be participating in a training session involving anaesthetic practice on a low-fidelity simulator. On the day of the simulation, residents were individually welcomed in a briefing room by an anaesthetist specialised in mental preparation. Group assignment was revealed from a sealed envelope and residents were informed that the simulation would involve acting as the on-call anaesthesia resident in a maternity ward. The scenario began with a call from a midwife requesting an epidural placement for a laboring patient. Depending on their assigned group, residents either received a mental preparation session or proceeded without it.
| Arm | Type | Receives |
|---|---|---|
| Control group (no mental training) | No intervention | –Residents in the control group did not undergo any mental training prior to performing epidural placement. |
| Mental training group | Experimental | Procedure: Mental training groupMental Training Group: Residents in the "Mental Training" group received a mental preparation session led by an anaesthesia physician qualified in medical pedagogy. Inspired by the "Breathe, Talk, See, Focus" procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Mental training groupMental Training Group: Residents in the "Mental Training" group received a mental preparation session led by an anaesthesia physician qualified in medical pedagogy. Inspired by the "Breathe, Talk, See, Focus" procedure | Procedure or surgery | Mental training group |
Primary outcome
Comparison of the stress levels before and after performing obstetric epidural anaesthesia between residents who received mental preparation and those who did not.
Time frame: Immediately after the simulation
Thestress level was evaluated using the State-Trait Anxiety Inventory 6 (STAI-6) score
4 secondary outcomes
Technical performance evaluation
Time frame: During the simulation
Non-technical skills evaluation
Time frame: During the simulation
Mental imagery abilities evaluation
Time frame: Immediatly after the simulation
Residents' satisfaction score
Time frame: Immediatly after the simulation
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 19 Sep 2025.
- Derived from this study: PubMed 41248877Fluteau L, Bourdon-Castel S, Kallout J, Lefevre-Scelles A, Sibert L, Besnier E, Clavier T, Compere V, Selim J. Impact of Mental Training on the stress of anaesthesiology residents before performing obstetrical epidural analgesia: A prospective randomised educational trial. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101675. doi: 10.1016/j.accpm.2025.101675. Epub 2025 Nov 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental training group in people with Medical Education and Resident Education, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. 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?
Comparison of the stress levels before and after performing obstetric epidural anaesthesia between residents who received mental preparation and those who did not. (time frame: Immediately after the simulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183618, which also lists 1 linked publication.
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 19 Sep 2025.