NCT04159389

Brief Summary

The purpose of this study is to evaluate the benefit of adding mental visualization to a training program in medical education. Undergraduate medical students will be randomized before participating in a training program on airway management during rapid sequence induction. In the control group, participants will receive traditional teaching including theoretical courses and procedural simulation. In the intervention group, in addition to traditional teaching, participants will be trained and encouraged to practice mental visualization. The main outcome will be clinical performance during a standardized high-fidelity simulation of rapid sequence induction assessed using a specific pre-established checklist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

October 26, 2019

Last Update Submit

November 28, 2023

Conditions

Keywords

airway managementpedagogylearning processmental visualizationrapide sequence induction

Outcome Measures

Primary Outcomes (1)

  • Clinical performance for airway management in a standardized high-fidelity simulation of rapid sequence induction.

    All simulations will be videotaped and the clinical performance of each participant will be assessed by an independent evaluator using a specific pre-established checklist

    2 weeks

Secondary Outcomes (8)

  • "Material preparation" score, subpart 1 of the clinical performance grid

    2 weeks

  • "Intubation procedure" score, subpart 2 of the clinical performance grid

    2 weeks

  • Physiological stress response : SDNN

    2 weeks

  • Psychological stress response : Stress-VAS

    2 weeks

  • Psychological stress response : STAI

    2 weeks

  • +3 more secondary outcomes

Study Arms (2)

traditional teaching

NO INTERVENTION

theoretical courses and procedural simulation on airway management during rapid sequence induction

Mental visualization

EXPERIMENTAL

traditional teaching completed by mental visualization : theoretical courses and procedural simulation on airway management during rapid sequence induction + mental visualization (theoretical courses, audioguide for individual practice and experience sharing session)

Other: Mental visualization

Interventions

Instruction in mental visualization by theoretical lessons and support of practice by audio guide and session of experience sharing.

Mental visualization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergraduate medical students from the Grenoble Alps university hospital
  • From the 2nd to the 6th year
  • Volontary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Grenoble Alps

La Tronche, 38700, France

Location

Study Design

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

Study Record Dates

First Submitted

October 26, 2019

First Posted

November 12, 2019

Study Start

January 6, 2020

Primary Completion

December 5, 2021

Study Completion

March 5, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations