MIxed ReAlity Versus Manikin Simulation in Basic Life Support Training for Medical Students: a Noninferiority Randomized Controlled Trial (MIRA).

NCT06832072 | Completed

• 1 other identifier: CER-2023-ART-SIM
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To compare the effectiveness of mixed reality and traditional manikin-based simulation in basic life support (BLS) training, making the hypothesis that mixed reality was non-inferior to manikin-based simulation. Methods: Non-inferiority randomized controlled trial. Third-year medical students were randomized in two groups. The mixed reality group (MR) received 32 minutes of individual training using a virtual reality headset and a torso for chest compressions (CC). The manikin simulation group (MK) participated in 2 hours of group training with theoretical and practical sessions using a low-fidelity manikin. The primary outcome was the overall BLS performance score, assessed at one month through a standardized BLS scenario, using a 10-item assessment scale. The quality of CC, students' satisfaction and confidence levels were secondary outcomes, assessed through superiority analyses.

Conditions

Medical Education; Simulation-based Methodology; Virtual Reality; Cardiac Arrest (CA); Medical Students

Outcome Measures

Primary Outcomes (1)

• Participants' overall BLS performance at one month after the course

  Primary outcome was measured one month after the BLS course by an independent and blinded evaluator using the BLS performance score. It is a 10-item assessment scale, based on the validated Cardiff score, modified according to the 2021 ERC recommendations. It contains the BLS steps, following the chain of survival. Each item is scored as achieved (1) or not achieved (0), for a total score out of 10 points. Each student's performance was assessed through a standardized simulated cardiac arrest scenario. The evaluation followed a standardized protocol and was reported in an electronic Case Report Form (eCRF) using Google Forms©.

  One month after the inclusion

Secondary Outcomes (6)

• Chest compression mean depth

  One month after the inclusion

• Chest compression (CC) mean rythm

  One month after the inclusion

• Rate of optimal chest compressions (CC)

  One month after the inclusion

• Time to first electric shock

  One month after the inclusion

• Mixed reality tolerance

  30 minutes after the inclusion : at the end of the course.

Study Arms (2)

MR-BLS

EXPERIMENTAL

Control group. In MK, medical students attended a two-hour course. Each course included a 30-minute theoretical lecture on BLS steps followed by several BLS simulation scenarios using low-fidelity manikin. Each scenario was debriefed and a tablet (Laerdal Simpad®, Laerdal, Stavanger, Norway) was used to provide feedback on chest compression rate and depth. Two to three students participated together in one scenario. The teacher-to-student ratio ranged between 1:16 and 1:20.

Other: MR-BLS

MK

NO INTERVENTION

Control group. In MK, medical students attended a two-hour course. Each course included a 30-minute theoretical lecture on BLS steps followed by several BLS simulation scenarios using low-fidelity manikin. Each scenario was debriefed and a tablet (Laerdal Simpad®, Laerdal, Stavanger, Norway) was used to provide feedback on chest compression rate and depth. Two to three students participated together in one scenario. The teacher-to-student ratio ranged between 1:16 and 1:20.

Interventions

MR-BLS OTHER

In MR group, students attended a 32 minutes course, in groups of four students with one teacher. The course included 22 minutes of individual MR training using headset (HTC Vive Focus 3®) and 10 minutes of debriefing. The individual MR training contained a step-by-step BLS reminder, including chest compression practice. Then, students engaged in a standardized virtual scenario where they interacted with both virtual characters and a physical manikin torso. The headset overlaid digital elements onto the real world, allowing the students to perform BLS while receiving real-time feedback. The feedback system provided visual cues indicating whether their chest compression rate and depth were correct. The teacher-to-student ratio was 1:4

Also known as: Medical education Device

MR-BLS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• rd year medical students
• engaged in a universitary course "cardiac arrest"

You may not qualify if:

• refusal to participate
• incapacity to realise BLS

Sponsors & Collaborators

• Sorbonne University: lead

Study Sites (1)

Hopital Pitie-Salpetriere 83, boulevard de l'hopital

Paris, 75011, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 18, 2025
• Study Start: December 1, 2023
• Primary Completion: April 15, 2024
• Study Completion: July 1, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

FR (1)