The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students

NCT ID: NCT06630143

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2025-03-31

Brief Summary

Objective:

To evaluate the effectiveness of a combined virtual and clinical simulation strategy compared to virtual simulation alone and clinical simulation alone in the development of theoretical knowledge and clinical judgment among midwifery students, specifically in the management of preeclampsia.

Study Population:

75 undergraduate midwifery students in the second cycle of their studies at the Universidad de Los Andes, Chile.

Interventions:

Group 1: Virtual and Clinical Simulation combined (VSim® case on preeclampsia followed by hands-on clinical simulation with a manikin).

Group 2: Virtual Simulation only (VSim® case on preeclampsia).

Primary Outcomes:

Development of theoretical knowledge (measured by a test) on preeclampsia. Improvement in clinical judgment skills (assessed using the Lasater Clinical Judgment Rubric).

Secondary Outcomes:

Student satisfaction with the training. Perceived self-efficacy in managing preeclampsia. Usability of simulation platform

Duration:

The intervention lasts for 4 days. Pre- and post-tests will assess knowledge, clinical judgment, satisfaction, and self-efficacy.

Methodology:

A randomized controlled trial (RCT) with 35 participants divided equally into two groups. Each group will undergo either virtual simulation, or both. Data analysis will involve repeated measures ANOVA to assess the differences in learning outcomes between the groups.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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 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.

Group Type: EXPERIMENTAL

Combined Virtual and Clinical Simulation

Intervention Type: OTHER

Participants will complete a 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 Simulation Arm

Participants in this arm will undergo a virtual simulation using the vSim® platform, which focuses on a 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.

Group Type: ACTIVE_COMPARATOR

virtual simulation

Intervention Type: OTHER

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

Interventions

Combined Virtual and Clinical Simulation

Participants will complete a 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.

Intervention Type: OTHER

virtual simulation

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

Intervention Type: OTHER

Other Intervention Names

vSim

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Universidad de los Andes, Chile

OTHER

Sponsor Role: lead

Responsible Party

Andrea López Navarrete

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de los Andes, Chile

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

andrea AL lopez, PhD Candidate

Role: CONTACT

aslopez@uandes.cl

+56 9 7218 8830

Facility Contacts

andrea lopez

Role: primary

aslopez@uandes.cl

972188830

Other Identifiers

CEC2024016

Identifier Type: -

Identifier Source: org_study_id