3D Modalities for Medical Student Education of Congenital Heart Disease

NCT07295730 | Completed

• 1 other identifier: STUDY20240627
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does using 3D-printed heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
2. 2.Does using augmented reality heart models improve learners' understanding of congenital heart disease when compared to traditional slide-based teaching methods?
3. 3.How can these modalities best be integrated into standard medical school curricula?
4. 4.Take a pre-test consisting of questions regarding anatomy and physiology of the normal heart as well as two congenital heart diseases.
5. 5.Be randomized into 3 groups that receive a teaching session using either slide-based lecture, 3D-printed models, or augmented reality.
6. 6.Take a post-test of the same questions from the pre-test.
7. 7.Take a delayed post-test of the same questions with additional subjective questions about their experience with their assigned modality.

Conditions

Tetralogy of Fallot (TOF); Hypoplastic Left Heart Syndrome (HLHS)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Slide-based lecture

OTHER

Participants in this group received teaching using a slide-based lecture

Other: 3D-printed heart models and augmented reality

3D-printed Model

ACTIVE COMPARATOR

This group received teaching using 3D-printed models

Other: 3D-printed heart models and augmented reality

Augmented Reality

ACTIVE COMPARATOR

This group received teaching using augmented reality headsets

Other: 3D-printed heart models and augmented reality

Interventions

3D-printed heart models and augmented reality OTHER

Participants will receive an educational session regarding congenital heart disease using a slide-based lecture, 3D-printed models, or augmented reality headsets.

3D-printed Model; Augmented Reality; Slide-based lecture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First year medical student

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University School of Medicine

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Tetralogy of Fallot; Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Arpit Agarwal, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 22, 2025
• Study Start: November 20, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)