Effects of a 3D-Printed Port-A Catheter Model Training Course

NCT ID: NCT06417294

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-31

Brief Summary

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The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education.

Detailed Description

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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. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care.

Methods: This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach.

Effect: The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education.

Conditions

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Patient Satisfaction Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3D model group

Received a explanation combined with 3D printed model

Group Type EXPERIMENTAL

3D health education model

Intervention Type OTHER

explanation combined with 3D printed health education model

traditional education group

Received a regular education

Group Type ACTIVE_COMPARATOR

traditional education

Intervention Type OTHER

Regular education

Interventions

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3D health education model

explanation combined with 3D printed health education model

Intervention Type OTHER

traditional education

Regular education

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital
* Have Chinese communication skills

Exclusion Criteria

* Refused to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University Hospital

Locations

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Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ke-Yun Chao, PhD

Role: CONTACT

+886905301879

Facility Contacts

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Ke-Yun Chao, PhD

Role: primary

+886-905-301-879

Other Identifiers

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FJUH112278

Identifier Type: -

Identifier Source: org_study_id

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