3D Modalities for Medical Student Education of Congenital Heart Disease

Use of 3D-printed Models and Augmented Reality in Medical Student Education of Congenital Heart Disease: Randomized Controlled Trial

The goal of this clinical trial is to learn if 3D-printed heart models and augmented reality can be useful modalities to teach medical students about congenital heart disease. The main questions it aims to answer are:

1. Does using 3D-printed heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
2. Does using augmented reality heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
3. How can these modalities best be integrated into standard medical school curricula?

Participants will:

1. Take a pre-test consisting of questions regarding anatomy and physiology of the normal heart as well as two congenital heart diseases.
2. Be randomized into 3 groups that receive a teaching session using either slide-based lecture, 3D-printed models, or augmented reality.
3. Take a post-test of the same questions from the pre-test.
4. Take a delayed post-test of the same questions with additional subjective questions about their experience with their assigned modality.

Study Overview

• Status: Completed
• Conditions: Hypoplastic Left Heart Syndrome (HLHS); Tetralogy of Fallot (TOF)
• Intervention / Treatment: Other: 3D-printed heart models and augmented reality

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• First year medical student

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Slide-based lecture; Participants in this group received teaching using a slide-based lecture	Other: 3D-printed heart models and augmented reality; Participants will receive an educational session regarding congenital heart disease using a slide-based lecture, 3D-printed models, or augmented reality headsets.
Active Comparator: 3D-printed Model; This group received teaching using 3D-printed models	Other: 3D-printed heart models and augmented reality; Participants will receive an educational session regarding congenital heart disease using a slide-based lecture, 3D-printed models, or augmented reality headsets.
Active Comparator: Augmented Reality; This group received teaching using augmented reality headsets	Other: 3D-printed heart models and augmented reality; Participants will receive an educational session regarding congenital heart disease using a slide-based lecture, 3D-printed models, or augmented reality headsets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pre and Post-test Scores	Participants completed a 16-item, multiple choice questionnaire about the anatomy and physiology of the normal heart and two complex congenital heart defects. The questionnaire is broken down into 4 questions on basic cardiology and 6 questions each pertaining specifically to tetralogy of Fallot and hypoplastic left heart syndrome. The questionnaire is delivered pre-intervention, immediately post-intervention, and again at 3-weeks post intervention. Correct answers are scored as true (1) and incorrect answers scored as false (0) with a score range of 0-16 with higher scores indicating better retention and understanding of the curriculum.	Enrollment Pre-Intervention, Baseline Post-Intervention, and 3 Weeks Post-Intervention

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Arpit Agarwal, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Estimated): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tetralogy of Fallot; Hypoplastic Left Heart Syndrome
• Other Study ID Numbers: STUDY20240627

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No