The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students

Not Applicable

Recruiting

• Conditions: Simulation Training; Midwifery Students Education; Clinical Competence; Education, Health; Virtual Simulation
• Interventions: Other: virtual simulation; Other: clinical simulation; Other: Combined Virtual and Clinical Simulation

• Registration Number: NCT06630143
• Lead Sponsor: Universidad de los Andes, Chile

Brief Summary

Objective:

To evaluate the effectiveness of a combined virtual and clinical simulation strategy compared to virtual simulation alone and clinical simulation alone in the development of theoretical knowledge and clinical judgment among midwifery students, specifically in the management of preeclampsia.

Study Population:

75 undergraduate midwifery students in the second cycle of their studies at the Universidad de Los Andes, Chile.

Interventions:

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

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

Primary Outcomes:

Development of theoretical knowledge (measured by a test) on preeclampsia. Improvement in clinical judgment skills (assessed using the Lasater Clinical Judgment Rubric).

Secondary Outcomes:

Student satisfaction with the training. Perceived self-efficacy in managing preeclampsia. Usability of simulation platform

Duration:

The intervention lasts for 4 days. Pre- and post-tests will assess knowledge, clinical judgment, satisfaction, and self-efficacy.

Methodology:

A randomized controlled trial (RCT) with 35 participants divided equally into two groups. Each group will undergo either virtual simulation, or both. Data analysis will involve repeated measures ANOVA to assess the differences in learning outcomes between the groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Study Start: 2024-11-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Simulation Arm	virtual simulation	Participants in this arm will undergo a virtual simulation using the vSim® platform, which focuses on a 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.
Clinical Simulation Arm	clinical simulation	Participants in this arm will engage in a clinical simulation using a high-fidelity manikin to simulate the management of a preeclampsia patient. This intervention provides hands-on experience and aims to develop clinical judgment and practical skills. The goal is to evaluate the effectiveness of clinical simulation alone in improving knowledge and clinical decision-making.
Combined Virtual and Clinical Simulation Arm	Combined Virtual and Clinical Simulation	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 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.

Primary Outcome Measures

Name	Time	Method
Clinical Judgment in Managing Preeclampsia	Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).	Clinical judgment will be evaluated using 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.
Theoretical Knowledge on Preeclampsia	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 preeclampsia.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the Learning Experience	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.
Perceived Self-Efficacy in Managing Preeclampsia	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.
Usability of simulation platform	Immediately after the completion of the assigned intervention.	The usability of the virtual and clinical simulation platforms will be assessed using the System Usability Scale (SUS), a widely used questionnaire that evaluates the ease of use, efficiency, and satisfaction with the simulation platforms. This outcome will provide insight into how user-friendly the simulation technologies are for midwifery students. The total SUS score ranges from 0 (minimum) to 100 (maximum), where higher scores indicate better usability. A SUS score above 68 is considered above average usability, while scores below that are considered below average.

Trial Locations

Locations (1)

Universidad de los Andes, Chile; 🇨🇱 Santiago, Metropolitana, Chile