Simulation TrainingNCT06630143
The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students
A study testing Combined Virtual and Clinical Simulation and virtual simulation in people with Simulation Training and Midwifery Students Education, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simulation Training, Midwifery Students Education, Clinical Competence
- What is being tested?
- Combined Virtual and Clinical Simulation and virtual simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChile
- Study dates
- 6 Jan 2025to 25 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de los Andes, Chile
Santiago, Santiago Metropolitan, 7620086
About this study
Official title: Effectiveness of Virtual Simulation Combined With Clinical Simulation in the Learning of Midwifery Students: A Randomized Clinical Trial
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.
Read more
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
- Being tested
- Combined Virtual and Clinical Simulation, virtual simulation
- Keywords
- virtual simulation, clinical simulation, clinical judgment, randomized clinical trial, preeclampsia
- Medical subject headings
- Health Education, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Virtual and Clinical SimulationOther
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.
virtual simulationOther
Also called vSim
Participants will complete the severe preeclampsia case scenario using the vSim® platform, allowing them to engage in virtual clinical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: virtual simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
Secondary outcomes (2)
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.
Measured: 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.
Measured: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start6 Jan 2025
- Primary completion20 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Andrea López Navarrete, Finis Terrae University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630143
- Sponsor's protocol ID
- CEC2024016
- Status last verified
- Mar 2025
- First submitted
- 24 Sep 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Simulation Combined With Clinical Simulation in the Learning of Midwifery Students: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06630143
- Acronym / sponsor ID
- CEC2024016
- Conditions
- Simulation Training, Midwifery Students Education, Clinical Competence, Education, Health, Virtual Simulation
- Keywords
- virtual simulation, clinical simulation, clinical judgment, randomized clinical trial, preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Virtual and Clinical Simulation Arm | Experimental | Other: Combined Virtual and Clinical SimulationParticipants 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. |
| Virtual Simulation Arm | Active comparator | Other: virtual simulationParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Virtual and Clinical SimulationParticipants 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. | Other | Combined Virtual and Clinical Simulation Arm |
| virtual simulationAlso: vSimParticipants will complete the severe preeclampsia case scenario using the vSim® platform, allowing them to engage in virtual clinical decision-making. | Other | Virtual Simulation Arm |
Primary outcome
Clinical Judgment in Managing Preeclampsia
Time frame: 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
Time frame: 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.
2 secondary outcomes
Satisfaction with the Learning Experience
Time frame: Immediately after the assigned intervention
Perceived Self-Efficacy in Managing Preeclampsia
Time frame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Virtual and Clinical Simulation and virtual simulation in people with Simulation Training and Midwifery Students Education, run by Universidad de los Andes, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Judgment in Managing Preeclampsia (time frame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.