- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468942
Virtual Reality Versus Computer-Based Simulation in Electrocardiogram Education (VR-CBS-ECG)
Virtual Reality Versus Computer-Based Simulation in Electrocardiogram Education: Effects on Nursing Students' Knowledge, Skills, and Motivation: A Randomized Controlled Trial
The goal of this clinical trial is to compare the effects of immersive virtual reality (VR) simulation and computer-based simulation (CBS) with traditional laboratory practice on electrocardiogram (ECG) knowledge, practical skills, and motivation in first-year undergraduate nursing students. The main questions it aims to answer are:
Does VR simulation improve ECG knowledge scores more than CBS and traditional laboratory practice? Does VR simulation improve ECG practical skill scores more than CBS and traditional laboratory practice? Does VR simulation improve learner motivation more than CBS and traditional laboratory practice?
Researchers will compare three groups - VR simulation, computer-based simulation, and traditional laboratory practice - to see which method is most effective for ECG education outcomes.
Participants will:
Attend a standardized 90-minute ECG lecture before the intervention Be randomly assigned to one of three groups: VR simulation, computer-based simulation, or traditional laboratory practice Complete a 90-minute educational intervention according to their assigned group Complete knowledge, skills, and motivation assessments before and one week after the intervention
Study Overview
Status
Conditions
Detailed Description
This three-arm randomized controlled trial was conducted at Beykent University, Istanbul, Turkey. The study population consisted of first-year undergraduate nursing students. Inclusion criteria were: voluntary participation, first-year enrollment, no prior ECG simulation training, and no visual impairment.
Sample size was calculated using G*Power 3.1.9.4 based on a medium effect size (f=0.40), α=0.05, and 80% power, yielding a minimum of 66 participants (22 per group). To account for potential attrition, 90 students were enrolled and randomly allocated to three groups: immersive virtual reality (VR) simulation (n=30), computer-based simulation (CBS) (n=30), and traditional laboratory practice (n=30).
All participants completed baseline assessments and attended a standardized 90-minute ECG lecture delivered by the same instructor. One week later, participants were randomly assigned to their intervention groups. The VR group performed three-dimensional ECG scenarios using Oculus Quest 2 (128GB) all-in-one headsets with integrated touch controllers, enabling full immersion and hand-tracking interactions simulating real ECG procedural movements. The CBS group completed interactive ECG modules developed with technical support from computer engineering specialists, covering ECG physiology, rhythm recognition scenarios, and nursing care protocols. The control group practiced on manikins with verbal instruction. All interventions lasted 90 minutes. Post-intervention assessments were conducted one week after the intervention.
Outcomes were assessed using three instruments. The ECG Knowledge Test is a researcher-developed multiple-choice test measuring ECG physiology, rhythm recognition, and interpretation, with content validity established by six medical-surgical nursing faculty. The ECG Skills Checklist is a researcher-developed checklist covering patient preparation, electrode placement, device operation, and strip interpretation, validated by five faculty experts; steps were scored as unsuccessful (0), requires improvement (2.5), or successful (5 points). The Instructional Materials Motivation Survey (IMMS) is a 33-item, 5-point Likert scale based on the ARCS model (Attention, Relevance, Confidence, Satisfaction), adapted to Turkish by Dinçer and Doğanay (2016); total scores range from 33 to 165, with higher scores indicating greater motivation. Cronbach's alpha in this study was 0.956.
Random allocation was conducted by an independent researcher not involved in data collection or intervention delivery, using a computer-generated random number sequence via www.random.org. Allocation concealment was maintained through sealed, sequentially numbered envelopes opened only after baseline assessments were recorded. Due to the nature of educational simulation interventions, blinding of participants and instructors was not feasible; however, the researcher responsible for baseline data collection was blinded to the randomization sequence before allocation.
Data were analyzed using IBM SPSS (v22.0). Normality was assessed via skewness, kurtosis, and the Shapiro-Wilk test. Between-group differences were examined using one-way ANOVA with post hoc Tukey tests. Within-group changes were assessed using repeated-measures ANOVA. ANCOVA was conducted with age and sex as covariates to account for baseline demographic imbalances. Partial eta-squared (η²) was used to index effect size. Significance was set at p<0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Koç University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- First-year undergraduate nursing student enrollment
- Voluntary participation
- No prior ECG simulation training experience
- No visual impairment
Exclusion Criteria:
- Prior ECG simulation training experience
- Visual impairment
- Unwillingness to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Simulation
Participants used an Oculus Quest 2 all-in-one headset with integrated touch controllers to perform three-dimensional ECG scenarios in an immersive virtual environment.
The intervention simulated real ECG procedural movements, including patient preparation, electrode placement, and device operation.
|
Participants wore an Oculus Quest 2 (128GB) all-in-one VR headset with integrated touch controllers for a 90-minute session.
Unlike screen-based approaches, this intervention provided full sensory immersion and hand-tracking interactions, enabling participants to physically simulate ECG procedures - including patient preparation, electrode placement, device operation, and rhythm strip interpretation - within a three-dimensional virtual clinical environment.
The embodied, sensorimotor engagement distinguishes this intervention from both computer-based and traditional modalities.
|
|
Experimental: Computer-Based Simulation
Participants completed interactive ECG training modules on computer screens.
The program covered ECG physiology, rhythm recognition scenarios, and nursing care protocols, developed with technical support from computer engineering specialists and validated by three medical-surgical nursing faculty.
|
ECG training program on standard computer screens.
The program was developed by the research team with technical support from computer engineering specialists and covered ECG physiology modules, rhythm recognition scenarios, and nursing care protocols.
Content validity was established by three medical-surgical nursing faculty.
Unlike immersive VR, this intervention provides visual interactivity without kinesthetic or sensorimotor engagement.
Unlike traditional practice, it offers structured digital feedback and repeated scenario exposure.
|
|
Other: Traditional Laboratory Practice
Participants practiced ECG skills on manikins with verbal instruction from the same instructor, following the standard laboratory curriculum.
|
manikin-based ECG skills session with verbal instruction delivered by the same instructor across all control group participants, following the standard nursing skills laboratory curriculum.
This intervention represents the conventional teaching approach without digital simulation, interactive feedback loops, or immersive technology, serving as the active control condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ECG Knowledge Score
Time Frame: two week after intervention
|
Measured using a researcher-developed multiple-choice ECG Knowledge Test covering ECG physiology, rhythm recognition, and interpretation.
Scores range from 0 to 100, with higher scores indicating greater knowledge.
|
two week after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ECG Practical Skill Score
Time Frame: Two week after intervention
|
Measured using a researcher-developed ECG Skills Checklist covering patient preparation, electrode placement, device operation, and strip interpretation.
Steps scored as unsuccessful (0), requires improvement (2.5), or successful (5 points).
|
Two week after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Learner Motivation
Time Frame: two week after intervention
|
Measured using the Instructional Materials Motivation Survey (IMMS), a 33-item, 5-point Likert scale based on the ARCS model.
Total scores range from 33 to 165, with higher scores indicating greater motivation toward instructional materials.
|
two week after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-10420511-050-15749
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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