The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students (NCT06630143) | Clinical Trial Compass
CompletedNot Applicable
The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students
Chile32 participantsStarted 2025-01-06
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Judgment in Managing Preeclampsia
Timeframe: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
2
Theoretical Knowledge on Preeclampsia
Timeframe: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).