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Medical EducationMIRANCT06832072

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

A study testing MR-BLS in people with Medical Education and Simulation-based Methodology, run by Sorbonne University at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
MR-BLS
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
1 siteFrance
Study dates
1 Dec 2023to 1 Jul 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
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 3rd year medical students
  • engaged in a universitary course "cardiac arrest"

Who cannot join

  • refusal to participate
  • incapacity to realise BLS

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Pitie-Salpetriere 83, boulevard de l'hopital

    Paris, 75011

Other trials in France

About this study

Official title: Mixed Reality Versus Manikin Simulation in Basic Life Support Training for Medical Students: a Noninferiority Randomized Controlled Trial.

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.

Read the detailed description

1.A. Context and Scientific Rationale

Out-of-hospital cardiac arrest is associated with a survival rate of less than 10% after hospital discharge (1). It is well established that the early initiation of basic cardiopulmonary resuscitation (CPR) directly influences patient survival (2). Training in basic CPR is therefore essential, particularly for medical students who will be confronted with cardiac arrest situations throughout their education and professional careers.

Simulation is currently the most widely used training tool for teaching CPR. It allows for the replication of real-world conditions by using mannequins and scenarios, placing learners in a "semi-authentic" context. This enables them to practice external chest compressions (ECC), organize basic CPR by calling for help, initiating ECC, and using an automated external defibrillator (AED). Simulation has demonstrated its effectiveness in teaching both technical skills and non-technical skills such as teamwork and communication (3,4).

New teaching methods, such as augmented reality (AR), allow immersion in virtual scenarios and interaction between physical and digital elements (5). Students can perform ECC on a mannequin while being immersed in a virtual scenario. Evaluating these new technologies is relevant to identify devices that could improve or innovate basic CPR training.

1.A.1. Current Practices in Basic CPR Training

Current training programs integrate various steps of the survival chain according to the European Resuscitation Council (ERC) guidelines (6). These steps include early recognition of cardiac arrest, calling emergency services, initiating chest compressions, and using an AED. Health simulation provides an immersive approach, exposing learners to simulated cardiac arrest situations with varying levels of realism. Using simulation mannequins, students can practice chest compressions and coordinate different CPR steps. Scenarios can be adapted to reflect different contexts, from hospital settings to emergency situations in daily life. This pedagogical approach enhances skill retention and builds confidence in responding effectively to emergencies (3). Furthermore, simulation offers a risk-free environment where errors can be identified and corrected, reinforcing hands-on learning.

1.A.2. Evaluating the Use of Virtual and Augmented Reality in Basic CPR Training

A scoping review of the literature (Dubreucq et al., in submission) was conducted to assess the use of virtual and augmented reality in basic CPR training. The analysis of 22 included studies did not conclude that virtual or augmented reality training was superior to "traditional" training, as control groups varied greatly across studies, making comparisons difficult. The primary assessment criteria used included theoretical knowledge, overall CPR performance, and the quality of ECC. The latter parameter is the most frequently evaluated and appears to be relevant due to its direct impact on survival (7).

1.A.3. Study Objectives

The present study aims to compare two CPR teaching methods: one using an augmented reality device and the other employing conventional simulation-based training. The quality of CPR performed by participants in both groups will be compared after training.

  1. B. Objectives and Hypotheses This is a single-blind, non-inferiority randomized controlled trial comparing basic CPR training using augmented reality (AR group) to low-fidelity simulation-based training, which is currently used at the medical school (control group). The primary objective is to compare the overall CPR performance of both groups in a 2-minute scenario, assessed one month after training using a 10-item checklist (Appendix 1). Secondary objectives will be detailed afterward. General Hypothesis The study hypothesis is that augmented reality is at least as effective as low-fidelity simulation for learning basic CPR.
  2. MATERIALS AND METHODS

2.A. Participants

Number of Participants: 225

Recruitment Method:

Third-year medical students at Sorbonne University participating in the mandatory "Cardiac Arrest Level 1" training.

All students enrolled in the training will receive an email with an information notice and will be invited to sign a consent form after attending a preliminary information session explaining the study.

Participation in the study is independent of participation in the mandatory training; students may decline to participate and will still attend the regular training session using traditional mannequin-based simulation.

The one-month assessment will be presented as optional for study participants, who may withdraw at any time.

Inclusion Criteria: Third-year medical students attending "Cardiac Arrest Level 1" training.

Exclusion Criteria: Declining participation in the study, physical inability to perform basic CPR (self-reported).

Randomization: After consent is obtained, participants will be randomized by training date. Sessions will be assigned randomly to the "simulation" or "augmented reality" group, with 16 students per AR session and 16-20 students per simulation session. Randomization will occur one month before the start of training. Non-participating students will attend standard simulation training without randomization.

Being tested
MR-BLS
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MR-BLSOther

    Also called Medical education Device

    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

Study groups in NCT06832072
Study groupRoleWhat they receive
MR-BLSExperimentalControl 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.
Receives: Other: MR-BLS
MKNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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©.

    Measured: One month after the inclusion

Secondary outcomes (6)
  1. Chest compression mean depth

    Mean depth of chest compression , during 2 minutes of BLS

    Measured: One month after the inclusion

  2. Chest compression (CC) mean rythm

    Mean rythm of CC, during 2 minutes of BLS

    Measured: One month after the inclusion

  3. Rate of optimal chest compressions (CC)

    Rate of CC with a correct rythm (100-120/min) and with a correct depth (5-6cm)

    Measured: One month after the inclusion

  4. Time to first electric shock

    Time to first electric shock in seconds

    Measured: One month after the inclusion

  5. Mixed reality tolerance

    Look after adverse event after using mixed reality device (headache, nausaea...)

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

  6. Confidence and lernears' satisfaction after the course

    On a Likert scale : lerners report their confidence to initiate BLS, and their satisafaction regarding the course they endorsed.

    Measured: One month after the inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start1 Dec 2023
  3. Primary completion15 Apr 2024
  4. Study completion1 Jul 2024

Resources

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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832072
Sponsor's protocol ID
CER-2023-ART-SIM
Acronym
MIRA
Status last verified
Feb 2025
First submitted
7 Feb 2025
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: * study protocol * data of primary and secondary outcomes * inform consent form

Questions about this trial

What is this clinical trial studying?

A study testing MR-BLS in people with Medical Education and Simulation-based Methodology, run by Sorbonne 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 2 inclusion and 2 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 18 Feb 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?

Participants' overall BLS performance at one month after the course (time frame: One month after the inclusion). 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 18 Feb 2025.

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