Satisfaction, PersonalNCT05760365
Three-dimensional Printing in Cardiac Catheterization
A study testing 3D printed educational model and Slide-based presention in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
Our purpose is to use 3D printing technology to make human anatomical cardiovascular model, which could apply in the medical education for medical students, in order to improve the effectiveness of the learning process to access. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Personal
- What is being tested?
- 3D printed educational model and Slide-based presention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital
Who cannot join
- Refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: The Improvement of Medical Education by Using the Application of Three-dimensional Printing in Cardiac Catheterization
Our purpose is to use 3D printing technology to make human anatomical cardiovascular model, which could apply in the medical education for medical students, in order to improve the effectiveness of the learning process to access.
Read the detailed description
Background：
The medical teaching models are expansive and rare. We try to use the 3D printing technology to print cardiovascular model. By using the 3D cardiovascular model, we try to facilitate the leaning curve of understanding the cardiac catheterization.
Study Design：
This is a single-site prospective randomized controlled trial of medical education. We expect to enrolled 50 participants. Both group will receive same teaching program. Traditional education model will be used in control group, and 3D printed model will be used in the experimental group.
Methods：
We use 3D printing technology to create cardiovascular model from the CT scanning, which are drawn by professional 3D drawing staff. The students will be divided into 2 groups: the first group receive lecture/image teaching first then trained by the 3D cardiovascular model; the second group are receiving the reverse order. The satisfaction and the learning outcomes would be evaluated by the questionnaire.
Effect：
We expect the 3D cardiovascular model will bring better learning efficiency and satisfaction. Furthermore, we will construct the individual learning project by using the 3D printing model.
Key words：
3D printing, anatomy instruction, cardiovascular system, cardiac catheterization, high-fidelity simulation.
- Conditions
- Satisfaction, Personal
- Being tested
- 3D printed educational model, Slide-based presention
- Keywords
- 3D printed, medical education, cardiac catheterization, Heart disease
- Medical subject headings
- Personal Satisfaction, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed educational modelOther
3D printed cardiac catheterization model
Slide-based presentionOther
Slide-based presention
| Study group | Role | What they receive |
|---|---|---|
| Slide-based presention group | Active comparator | Received a regular learning Receives: Other: Slide-based presention |
| 3D-printed presention group | Experimental | Received a regular learning plus 3D printing model Receives: Other: 3D printed educational model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination score of pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome
Measured: pre-intervention
Examination score of post-intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start2 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PersonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760365
- Sponsor's protocol ID
- FJUH110157
- Status last verified
- Sep 2024
- First submitted
- 27 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement of Medical Education by Using the Application of Three-dimensional Printing in Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT05760365
- Acronym / sponsor ID
- FJUH110157
- Conditions
- Satisfaction, Personal
- Keywords
- 3D printed, medical education, cardiac catheterization, Heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our purpose is to use 3D printing technology to make human anatomical cardiovascular model, which could apply in the medical education for medical students, in order to improve the effectiveness of the learning process to access.
Detailed description
Background：
The medical teaching models are expansive and rare. We try to use the 3D printing technology to print cardiovascular model. By using the 3D cardiovascular model, we try to facilitate the leaning curve of understanding the cardiac catheterization.
Study Design：
This is a single-site prospective randomized controlled trial of medical education. We expect to enrolled 50 participants. Both group will receive same teaching program. Traditional education model will be used in control group, and 3D printed model will be used in the experimental group.
Methods：
We use 3D printing technology to create cardiovascular model from the CT scanning, which are drawn by professional 3D drawing staff. The students will be divided into 2 groups: the first group receive lecture/image teaching first then trained by the 3D cardiovascular model; the second group are receiving the reverse order. The satisfaction and the learning outcomes would be evaluated by the questionnaire.
Effect：
We expect the 3D cardiovascular model will bring better learning efficiency and satisfaction. Furthermore, we will construct the individual learning project by using the 3D printing model.
Key words：
3D printing, anatomy instruction, cardiovascular system, cardiac catheterization, high-fidelity simulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slide-based presention group | Active comparator | Other: Slide-based presentionReceived a regular learning |
| 3D-printed presention group | Experimental | Other: 3D printed educational modelReceived a regular learning plus 3D printing model |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital
Key exclusion criteria (1 listed)
- Refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed educational model3D printed cardiac catheterization model | Other | 3D-printed presention group |
| Slide-based presentionSlide-based presention | Other | Slide-based presention group |
Primary outcome
Examination score of pre-intervention
Time frame: pre-intervention
score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome
Examination score of post-intervention
Time frame: immediately after the intervention
score of post-intervention (maximun 100 and minimum 0), higher means a better outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed educational model and Slide-based presention in people with Satisfaction, Personal, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination score of pre-intervention (time frame: pre-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.