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NCT Number: NCT06630143

The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students

Objective:

To evaluate the effectiveness of combined virtual and high-fidelity clinical simulation compared with virtual simulation only on theoretical knowledge and clinical judgment in undergraduate midwifery students managing severe preeclampsia.

Study Population:

Thirty-two undergraduate midwifery students enrolled in a maternal health clinical course at Universidad de los Andes, Chile.

Interventions:

Group 1 (intervention): Virtual and Clinical Simulation combined (VSim® case followed by hands-on clinical simulation with a manikin).

Group 2 (control): Virtual Simulation only (VSim® case).

Primary Outcomes:

Development of theoretical knowledge (measured by a test) on severe preeclampsia.

Improvement in clinical judgment skills (assessed using the Spanish Lasater Clinical Judgment Rubric).

Secondary Outcomes:

Student satisfaction with the training. Perceived self-efficacy in managing severe preeclampsia.

Duration:

The intervention period lasted five days, including baseline assessment, access to learning activities, and post-intervention evaluation.

Methodology:

Randomized controlled trial with parallel groups (1:1 allocation). Changes over time and differences between groups were analysed using linear mixed-effects models.

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Key information

Conditions

Simulation Training Adherence Interventions Behavior Clinical Competence Education, Health Female Urogenital Diseases and Pregnancy Complications Health Behavior Health Education Hypertension, Pregnancy-Induced Medication Adherence Midwifery Students Education Patient Acceptance of Health Care Patient Compliance Pre-Eclampsia Pregnancy Complications Treatment Adherence and Compliance Urogenital Diseases Virtual Simulation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de los Andes, Chile

Santiago, Santiago Metropolitan, 7620086, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrollment Status: Students in the second cycle of the midwifery program at the University of Los Andes.
  • Educational Background: Participants must have completed the foundational courses in obstetrics and gynecology, as well as their initial clinical rotations.
  • Consent: Participants must provide written informed consent to participate in the study.

Exclusion criteria

  • Previous Clinical Experience: Students who have had prior clinical experience in high-risk obstetric units, or in preeclampsia management, will be excluded.
  • Other Professional Backgrounds: Individuals with a degree or professional certification in obstetric or gynecological nursing (e.g., technicians with a title in obstetric nursing) will not be eligible.
  • Exchange Students: Midwifery students participating in exchange programs will not be permitted to participate in the study.

Treatment and study plan

Combined Virtual and Clinical Simulation

Other

Participants will complete a severe preeclampsia case scenario through virtual simulation first and then engage in a clinical simulation involving the same case. This sequential intervention is designed to reinforce knowledge and skills.

Virtual simulation

Other

Participants will complete the severe preeclampsia case scenario using the vSim® platform, allowing them to engage in virtual clinical decision-making.

Other names: vSim

Primary outcomes

  1. Clinical Judgment in Managing Preeclampsia

    Time frame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).

    Clinical judgment will be evaluated using the Spanish version of the Lasater Clinical Judgment Rubric (LCJR), a tool designed to assess the ability to observe, interpret, respond, and reflect in clinical situations. The rubric will be applied during a standardized clinical simulation scenario for preeclampsia management. The LCJR consists of 11 items, each rated on a scale from 1 to 4, for a total score ranging from 11 (minimum) to 44 (maximum). Higher scores indicate better clinical judgment and a more effective ability to manage clinical situations.

  2. Theoretical Knowledge on Preeclampsia

    Time frame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).

    Theoretical knowledge will be assessed using a 10-item multiple-choice questionnaire specifically developed for this study, based on concepts from the American College of Obstetricians and Gynecologists (ACOG) and best practices for item construction. The test will be applied before and after the intervention to compare knowledge gains. The questionnaire will have a total score range of 0 (minimum) to 10 (maximum), with higher scores indicating better theoretical knowledge of severe preeclampsia.

Secondary outcomes

  1. Satisfaction with the Learning Experience

    Time frame: Immediately after the assigned intervention

    The satisfaction of participants with the educational interventions will be measured using the Clinical Simulation Satisfaction Survey. This 15-item survey will use a 5-point Likert scale to gauge participants; satisfaction with the simulation activities. The scale ranges from 15 (minimum) to 75 (maximum). Higher scores indicate greater satisfaction with the educational interventions.

  2. Perceived Self-Efficacy in Managing Preeclampsia

    Time frame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).

    Participants; perceived self-efficacy will be measured using the General Self-Efficacy Scale, validated for use in Chile. This scale contains 10 items rated on a 4-point Likert scale, assessing the participants' confidence in managing clinical situations like preeclampsia. The scale ranges from 10 (minimum) to 40 (maximum). Higher scores indicate greater perceived self-efficacy in managing clinical situations.

Sponsors and collaborators

Lead sponsor

Universidad de los Andes, Chile

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Effectiveness of Virtual Simulation Combined With Clinical Simulation in the Learning of Midwifery Students: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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