Satisfaction, PatientNCT06146998
Three-dimensional Thyroid Education Model
A study testing 3D health education model and Verbal explanation in people with Satisfaction, Patient, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for patient education. This model can assist them in gaining a better understanding of the thyroid's structure, providing patients with insights into their own conditions and thyroid fine needle aspiration examinations. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Satisfaction, Patient
- What is being tested?
- 3D health education model and Verbal explanation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroid nodule detected
- Thyroid ultrasound-guided fine-needle aspiration is needed
Who cannot join
- Previously underwent thyroid ultrasound-guided fine-needle aspiration
- 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: Development of 3D Printing High-Fidelity Thyroid Fine Needle Aspiration Exam Medical Education Model to Facilitate Patient Education
The purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for patient education. This model can assist them in gaining a better understanding of the thyroid's structure, providing patients with insights into their own conditions and thyroid fine needle aspiration examinations.
Read the detailed description
Background： Thyroid nodular disorder is one of the most common diseases in Endocrine clinics. And thyroid fine needle aspiration examination is the most important exam in evaluating the nature of thyroid nodules. In previous studies, 3D thyroid models have been introduced for patient education before thyroid surgery. Nevertheless, thyroid models that can be used to practice thyroid fine needle aspiration examination were scarce.
Study Design： This is a prospective study.
Methods： In our study, 3D printing technology will be used to create the thyroid high-fidelity model. We plan to choose 3D printing materials that explain thyroid fine needle aspiration for patient education efficacy evaluation.
Effect： Through the creation of this thyroid fine needle aspiration model, we hope to enhance patients' comprehension of the thyroid and thyroid nodules. The results of our study could be applied in hospitals to improve patient education.
Key words： 3D printing; medical education model; high-fidelity simulation; thyroid; fine needle aspiration
- Conditions
- Satisfaction, Patient
- Being tested
- 3D health education model, Verbal explanation
- Keywords
- 3D printing, medical education model, high-fidelity simulation, thyroid, fine needle aspiration
- Medical subject headings
- Patient Satisfaction, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D health education modelOther
explanation combined with 3D health education model
Verbal explanationOther
Regular explanation
| Study group | Role | What they receive |
|---|---|---|
| 3D model group | Experimental | Received a explanation combined with 3D medical education model Receives: Other: 3D health education model |
| traditional explanation group | Active comparator | Received a regular explanation Receives: Other: Verbal explanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical education effectiveness questionnaire
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 posted27 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- NCT06146998
- Sponsor's protocol ID
- FJUH111215
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 27 Nov 2023
- 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of 3D Printing High-Fidelity Thyroid Fine Needle Aspiration Exam Medical Education Model to Facilitate Patient Education
- ClinicalTrials.gov ID
- NCT06146998
- Acronym / sponsor ID
- FJUH111215
- Conditions
- Satisfaction, Patient
- Keywords
- 3D printing, medical education model, high-fidelity simulation, thyroid, fine needle aspiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 27 Nov 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.
The purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for patient education. This model can assist them in gaining a better understanding of the thyroid's structure, providing patients with insights into their own conditions and thyroid fine needle aspiration examinations.
Detailed description
Background： Thyroid nodular disorder is one of the most common diseases in Endocrine clinics. And thyroid fine needle aspiration examination is the most important exam in evaluating the nature of thyroid nodules. In previous studies, 3D thyroid models have been introduced for patient education before thyroid surgery. Nevertheless, thyroid models that can be used to practice thyroid fine needle aspiration examination were scarce.
Study Design： This is a prospective study.
Methods： In our study, 3D printing technology will be used to create the thyroid high-fidelity model. We plan to choose 3D printing materials that explain thyroid fine needle aspiration for patient education efficacy evaluation.
Effect： Through the creation of this thyroid fine needle aspiration model, we hope to enhance patients' comprehension of the thyroid and thyroid nodules. The results of our study could be applied in hospitals to improve patient education.
Key words： 3D printing; medical education model; high-fidelity simulation; thyroid; fine needle aspiration
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D model group | Experimental | Other: 3D health education modelReceived a explanation combined with 3D medical education model |
| traditional explanation group | Active comparator | Other: Verbal explanationReceived a regular explanation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thyroid nodule detected
- Thyroid ultrasound-guided fine-needle aspiration is needed
Key exclusion criteria (2 listed)
- Previously underwent thyroid ultrasound-guided fine-needle aspiration
- 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 health education modelexplanation combined with 3D health education model | Other | 3D model group |
| Verbal explanationRegular explanation | Other | traditional explanation group |
Primary outcome
Medical education effectiveness questionnaire
Time frame: immediately after the intervention
higher means a better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- 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 health education model and Verbal explanation in people with Satisfaction, Patient, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke-Yun Chao, PhD (+886905301879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical education effectiveness questionnaire (time frame: immediately after the intervention). 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 27 Nov 2023.