Three-dimensional Upper Gastrointestinal Tract Model

Sponsor
Fu Jen Catholic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06114433
Collaborator
(none)
60
1
2
10.8
5.6

Study Details

Study Description

Brief Summary

This study aims to develop an upper body manikin with a high-fidelity upper gastrointestinal tract and apply into the nasogastric tube training program for nursing students.

Condition or Disease Intervention/Treatment Phase
  • Other: 3D printed educational model
  • Other: Tranditional model education
N/A

Detailed Description

Background:

Nursing trainees often fail to correctly prepare medical supplies and use stethoscopes for position assessment incorrectly when physicians perform nasogastric tube placement techniques. The traditional training model are expensive and difficult to access or maintain. It is easy to cause irreparable damage when repeated tearing and sticking of the elastic adhesive tape on the traditional model. Because of the high-priced the traditional model, it is impossible to use real milk, to simulate the nasogastric tube feeding. Inadequate clinical skills often raises patient safety concerns when assisting in changing nose pads and feeding. To enhance the nasogastric tube training for nursing students, we used 3D-printed education model combined with clinical simulation-based training program.

Study Design:

This is a randomized controlled trial of medical education study.

Methods:

We first designed our 3D upper body model using the 3D processing and analysis software. To create the basic outline of the 3D model, we used a white-light handheld 3D scanner to scan a real human. To closely resemble the soft biological tissues of real human organs, an adequate material will be chosen in the study. The pre/post examination, student satisfaction, and direct observation of procedural skills will be used to evaluation the outcome of the study.

Effect:

We expect the 3D-printed upper body manikin with a high-fidelity upper gastrointestinal tract model has potential in nasogastric tube training, particularly in helping trainees become familiar with the nasogastric tube care.

Keywords:

3D printing, upper body manikin, upper gastrointestinal tract, nasogastric tube care, simulation-based training

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Development of A 3D Printing High-Fidelity Upper Gastrointestinal Tract Model for Nursing Students in the Nasogastric Tube Training
Actual Study Start Date :
Mar 10, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tranditional model group

Received a regular learning

Other: Tranditional model education
Slide-based presention plus tranditional model

Experimental: 3D-printed presention group

Received a regular learning plus 3D printing model

Other: 3D printed educational model
Slide-based presention plus 3D printed educational model

Outcome Measures

Primary Outcome Measures

  1. Examination score of direct observation of procedural skills [immediately after the intervention]

    score of direct observation of procedural skills (maximun 100 and minimum 0), higher means a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Training at Fu Jen Catholic University Hospital.

  • Signed the consent form.

Exclusion Criteria:
  • Refused to participate in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fu Jen Catholic University Hospital, Fu Jen Catholic University New Taipei City Taiwan 24352

Sponsors and Collaborators

  • Fu Jen Catholic University

Investigators

  • Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University
ClinicalTrials.gov Identifier:
NCT06114433
Other Study ID Numbers:
  • FJUH111192
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University

Study Results

No Results Posted as of Nov 2, 2023