Clinical trial NCT06758141: 3D Printed Advanced Cardiac Models for Transseptal Puncture, Cardiac Ablation, and Cardiac Tamponade Simulation Training
Official title: Using 3D Printed Advanced Cardiac Models for Transseptal Puncture, Cardiac Ablation, and Cardiac Tamponade Simulation Training to Enhance Medical Education: a Randomized Controlled Educational Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Satisfaction, Personal
Keywords: clinical simulation-based education
advanced cardiology procedures
transseptal puncture
cardiac ablation
cardiac tamponade
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to develop advanced cardiac models using 3D printing technology for teaching complex cardiology procedures such as (1) transseptal puncture, (2) cardiac ablation, and (3) ultrasound scanning and drainage of cardiac tamponade. By implementing this study, the investigators aim to transform the teaching methods for cardiology students at our hospital.

Detailed description: Background： The standard methodology for education in medicine, particularly in cardiology, still follows the apprenticeship model, where trainees observe, gradually take over, and practice under supervision until they can independently perform procedures. The traditional pedagogical strategy for complex medical procedures, like cardiac catheterization, emphasizes the "see one, do one, teach one" doctrine. Studies have revealed the superior efficacy of 3D printing in medical education, particularly in enhancing learning skills and knowledge among medical students. The demand for 3D printed models in medical education is increasing continuously.

Study Design：

This study is a single-center, pilot, prospective, randomized controlled educational trial.

Methods：

The trial will be conducted in the Department of Cardiovascular Medicine at Fu Jen Catholic University Hospital. The investigators plan to enroll 50 participants, who will be randomly assigned to either the 3D model training group (n=25) or the conventional curriculum group (n=25) in a 1:1 ratio. All participants will undergo pre- and post-training assessments, including a knowledge test (structured written questionnaire), an attitude assessment (semi-structured satisfaction questionnaire), and a skills evaluation (direct observation of procedural skills, DOPS).

Effect：

The investigators anticipate the development of a set of advanced 3D cardiac models for teaching cardiology procedures. It is expected that combining classroom learning with the viewing and interactive practice of 3D printed models will significantly improve the learning outcomes of the trainees.

Key words：

Clinical simulation-based education, advanced cardiology procedures, transseptal puncture, cardiac ablation, cardiac tamponade.

Eligibility criteria: Inclusion Criteria:

* Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital

Exclusion Criteria:

* Refused to participate in the study.

Primary outcomes:
measure: Examination score of pre-intervention
timeFrame: pre-intervention
measure: Examination score of post-intervention
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References: