Personal SatisfactionNCT06416943
3D Port-A Catheter Model for New Staff
A study testing 3D printed educational model in people with Personal Satisfaction and Cancer, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to enhance the effectiveness of training new nursing staff in Port-A catheter placement and care skills. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction, Cancer
- What is being tested?
- 3D printed educational model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2024to 31 Dec 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- New nursing staff joined 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: Effects of a 3D-Printed Port-A Catheter Model Training Course for New Staff
The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to enhance the effectiveness of training new nursing staff in Port-A catheter placement and care skills.
Read the detailed description
Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. Proper care and maintenance are crucial for the successful use of Port-A catheters. For nursing staff, acquiring professional knowledge in Port-A catheter care is essential for improving the quality of cancer patient care. Insufficient education and training in Port-A catheter care can lead to clinical errors that endanger patients' lives.
Methods： This study involves providing training to participants and assessing their performance and effectiveness. It employs a prospective quasi-experimental design with a single group and pre- and post-test evaluations. The study includes 50 newly recruited nursing staff.
Effect： The investigators anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in the training of newly recruited nursing staff.
- Conditions
- Personal Satisfaction, Cancer
- Being tested
- 3D printed educational model
- Keywords
- 3D printed model, port-a catheter, nursing skill education
- Medical subject headings
- Personal Satisfaction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed educational modelOther
Slide-based presention plus 3D printed port-A catheter model
| Study group | Role | What they receive |
|---|---|---|
| 3D medical education model 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 posted16 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal SatisfactionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT06416943
- Sponsor's protocol ID
- FJUH112278-2
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 3D-Printed Port-A Catheter Model Training Course for New Staff
- ClinicalTrials.gov ID
- NCT06416943
- Acronym / sponsor ID
- FJUH112278-2
- Conditions
- Personal Satisfaction, Cancer
- Keywords
- 3D printed model, port-a catheter, nursing skill education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 May 2024 (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 aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to enhance the effectiveness of training new nursing staff in Port-A catheter placement and care skills.
Detailed description
Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. Proper care and maintenance are crucial for the successful use of Port-A catheters. For nursing staff, acquiring professional knowledge in Port-A catheter care is essential for improving the quality of cancer patient care. Insufficient education and training in Port-A catheter care can lead to clinical errors that endanger patients' lives.
Methods： This study involves providing training to participants and assessing their performance and effectiveness. It employs a prospective quasi-experimental design with a single group and pre- and post-test evaluations. The study includes 50 newly recruited nursing staff.
Effect： The investigators anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in the training of newly recruited nursing staff.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D medical education model group | Experimental | Other: 3D printed educational modelReceived a regular learning plus 3D printing model |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- New nursing staff joined 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 modelSlide-based presention plus 3D printed port-A catheter model | Other | 3D medical education model 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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 in people with Personal Satisfaction and Cancer, 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: status not confirmed, as of the sponsor's last update on 3 Jun 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?
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 (+886-905-301-879, 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?
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 3 Jun 2024.