NCT07183618

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

21 days

First QC Date

September 12, 2025

Last Update Submit

September 12, 2025

Conditions

Keywords

anesthesia residencymental trainingobstetrical epidural anesthesiamedical education

Outcome Measures

Primary Outcomes (1)

  • 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

    Immediately after the simulation

Secondary Outcomes (4)

  • Technical performance evaluation

    During the simulation

  • Non-technical skills evaluation

    During the simulation

  • Mental imagery abilities evaluation

    Immediatly after the simulation

  • Residents' satisfaction score

    Immediatly after the simulation

Study Arms (2)

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

Procedure: Mental training group

Interventions

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

Mental training group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, Normandy, 76000, France

Location

Related Publications (1)

  • 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. 2025 Nov 15:101675. doi: 10.1016/j.accpm.2025.101675. Online ahead of print.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 19, 2025

Study Start

February 7, 2024

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations