Clinical trial NCT06630143: The Effectiveness of Combined Virtual and Clinical Simulation in Midwifery Students
Official title: Effectiveness of Virtual Simulation Combined With Clinical Simulation in the Learning of Midwifery Students: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Simulation Training
Midwifery Students Education
Clinical Competence
Education, Health
Virtual Simulation
Keywords: virtual simulation
clinical simulation
clinical judgment
randomized clinical trial
preeclampsia
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Clinical Judgment in Managing Preeclampsia
timeFrame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
measure: Theoretical Knowledge on Preeclampsia
timeFrame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
Secondary outcomes:
measure: Satisfaction with the Learning Experience
timeFrame: Immediately after the assigned intervention
measure: Perceived Self-Efficacy in Managing Preeclampsia
timeFrame: Pre-intervention (before randomization) and post-intervention (Immediately after the assigned intervention).
measure: Usability of simulation platform
timeFrame: Immediately after the completion of the assigned intervention.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de los Andes, Chile
state: Metropolitana
Study officials:
References: