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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06630143
Enrollment
32
Registered
2024-10-08
Start date
2025-01-06
Completion date
2025-01-25
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

virtual simulation, clinical simulation, clinical judgment, randomized clinical trial, preeclampsia

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.

Interventions

OTHERCombined 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.

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

Sponsors

Universidad de los Andes, Chile
Lead SponsorOTHER
University of Sao Paulo
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Judgment in Managing PreeclampsiaPre-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.
Theoretical Knowledge on PreeclampsiaPre-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

MeasureTime frameDescription
Satisfaction with the Learning ExperienceImmediately after the assigned interventionThe 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 PreeclampsiaPre-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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026