## Protocol Section
### Identification Module
**NCT ID:** NCT06416943

**Brief Title:** 3D Port-A Catheter Model for New Staff

**Official Title:** Effects of a 3D-Printed Port-A Catheter Model Training Course for New Staff

#### Organization Study ID Info
**ID:** FJUH112278-2
#### Organization
**Class:** OTHER
**Full Name:** Fu Jen Catholic University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fu Jen Catholic University

#### Responsible Party

**Investigator Affiliation:** Fu Jen Catholic University

**Investigator Full Name:** Ke-Yun, Chao

**Investigator Title:** Group leader of Respiratory Therapists

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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： We 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 Module

**Conditions:**

- Personal Satisfaction

- Cancer

**Keywords:**

- 3D printed model

- port-a catheter

- nursing skill education

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Received a regular learning plus 3D printing model

**Intervention Names:**

- Other: 3D printed educational model

**Label:** 3D medical education model group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 3D medical education model group

**Description:** Slide-based presention plus 3D printed port-A catheter model

**Name:** 3D printed educational model

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.

**Measure:** Examination score of pre-intervention

**Time Frame:** pre-intervention

**Description:** score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.

**Measure:** Examination score of post-intervention

**Time Frame:** immediately after the intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* New nursing staff joined Fu Jen Catholic University Hospital.

Exclusion Criteria:

* Refused to participate in the study.

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** C00152@mail.fjuh.fju.edu.tw

**Name:** Ke-Yun Chao, PhD

**Phone:** +886-905-301-879

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Taipei City

**Country:** Taiwan

**Facility:** Fu Jen Catholic University Hospital, Fu Jen Catholic University

**Zip:** 24352

#### Overall Officials

**Official 1:**

**Affiliation:** Fu Jen Catholic University Hospital

**Name:** Ke-Yun Chao, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
