The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students

NCT06630143 | Completed

• 1 other identifier: CEC2024016
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Simulation Training; Midwifery Students Education; Clinical Competence; Education, Health; Virtual Simulation

Keywords

virtual simulation; clinical simulation; clinical judgment; randomized clinical trial; preeclampsia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Satisfaction with the Learning Experience

  Immediately after the assigned intervention

• Perceived Self-Efficacy in Managing Preeclampsia

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

Study Arms (2)

Combined Virtual and Clinical Simulation Arm

EXPERIMENTAL

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

Virtual Simulation Arm

ACTIVE COMPARATOR

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

Interventions

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.

Combined Virtual and Clinical Simulation Arm

virtual simulation OTHER

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

Also known as: vSim

Virtual Simulation Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Universidad de los Andes, Chile

Santiago, Santiago Metropolitan, 7620086, Chile

Location

MeSH Terms

Conditions

Health Education; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation to minimise assessment bias. Evaluators were not informed whether participants belonged to the virtual simulation only group or the combined virtual and clinical simulation group. For clinical judgment assessment, performance was evaluated using the Spanish Lasater Clinical Judgment Rubric. All participants were identified using unique codes, and assessors received only coded performance records without any information regarding group assignment. This procedure ensured that outcome evaluation was conducted independently and without knowledge of the educational intervention received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 8, 2024
• Study Start: January 6, 2025
• Primary Completion: January 20, 2025
• Study Completion: January 25, 2025
• Last Updated: February 20, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)