The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students

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

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.

Study Overview

• Status: Completed
• Conditions: Simulation Training; Clinical Competence; Education, Health; Virtual Simulation; Midwifery Students Education
• Intervention / Treatment: Other: Combined Virtual and Clinical Simulation; Other: virtual simulation

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7620086
      • Universidad de los Andes, Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Virtual and Clinical Simulation Arm; Participants in this arm will receive a combination of virtual simulation using the vSim® platform and clinical simulation with a high-fidelity manikin. The virtual simulation focuses on the management of a severe preeclampsia case, which will be followed by a hands-on clinical simulation replicating the same scenario. This arm aims to assess whether combining both educational strategies enhances theoretical knowledge and clinical judgment more effectively than either method alone.	Other: Combined Virtual and Clinical Simulation; 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.
Active Comparator: Virtual Simulation Arm; Participants in this arm will undergo a virtual simulation using the vSim® platform, which focuses on a severe preeclampsia case. This intervention will help participants develop clinical reasoning and decision-making skills in a virtual environment. The objective is to measure the effectiveness of virtual simulation alone on theoretical knowledge and clinical judgment.	Other: virtual simulation; Participants will complete the severe preeclampsia case scenario using the vSim® platform, allowing them to engage in virtual clinical decision-making.; Other Names: vSim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Judgment in Managing Preeclampsia	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.	Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
Theoretical Knowledge on Preeclampsia	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.	Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the Learning Experience	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.	Immediately after the assigned intervention
Perceived Self-Efficacy in Managing Preeclampsia	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.	Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).

Collaborators and Investigators

• Sponsor: Universidad de los Andes, Chile
• Collaborators: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 25, 2025

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: randomized clinical trial; preeclampsia; virtual simulation; clinical simulation; clinical judgment
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Pre-Eclampsia; Health Education
• Other Study ID Numbers: CEC2024016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No