Effectiveness of Virtual Simulation Combined With Clinical Simulation in the Learning of Midwifery Students: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Clinical Judgment in Managing Preeclampsia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Combined Virtual and Clinical Simulation (Other)
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.
干预措施: virtual simulation (Other)
结局指标
主要结局
Clinical Judgment in Managing Preeclampsia
时间窗: Pre-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 Preeclampsia
时间窗: 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 severe preeclampsia.
次要结局
- 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).)
研究者
Andrea López Navarrete
Professor
Finis Terrae University