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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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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 (VSimĀ® case followed by hands-on clinical simulation with a manikin).
Group 2 (control): Virtual Simulation only (VSimĀ® 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Virtual and Clinical Simulation Arm | Experimental | Participants in this arm will receive a combination of virtual simulation using the vSimĀ® 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. |
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| Virtual Simulation Arm | Active Comparator | Participants in this arm will undergo a virtual simulation using the vSimĀ® 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with the Learning Experience | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de los Andes, Chile | Santiago | Santiago Metropolitan | 7620086 | Chile |
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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.
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| virtual simulation | Other | Participants will complete the severe preeclampsia case scenario using the vSimĀ® platform, allowing them to engage in virtual clinical decision-making. |
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| Immediately after the assigned intervention |
| Perceived Self-Efficacy in Managing Preeclampsia | 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. | Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention). |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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