- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326398
The Effect of Using 3D Printers and Moulage on Improving Stoma Care
The Effect of Using 3D Printers and Moulage on Improving Stoma Care Knowledge and Skills in Nursing Students
Study Overview
Detailed Description
A stoma is an opening created by inserting an organ into the skin using a surgical method. Colostomy, ileostomy and urostomy, in which excretion is provided through an opening created on the anterior wall of the abdomen outside normal anatomical pathways, are among the most commonly created stomas. Although stomas are created for various reasons, they are most commonly opened due to colorectal and bladder cancers.
According to the International Agency for Research on Cancer (IARC), colorectal cancer ranks 3rd and bladder cancer ranks 10th in all ages and genders. Although the exact number of individuals with a stoma worldwide is unknown, it is estimated that 18-35% of individuals diagnosed with cancer have to live with a stoma temporarily or permanently during the treatment process. In this regard, it is thought that the number of individuals with stoma will increase with the increase in colorectal and bladder cancers. This increase also increases the need for nursing care of individuals with stoma. Accordingly, it is important to provide this care skill to nursing students, who are the nurses of the future, during nursing education.
Nursing education; It includes multifaceted education and training activities including theoretical, laboratory and application areas. It is thought that students who gain sufficient knowledge and experience about stoma care during their studies provide effective care to individuals with stomas when they start working as professional nurses, and that their adaptation to stoma and quality of life increases with this care. Stoma care is among the basic nursing skills that nurses apply autonomously. While training student nurses on stoma care, methods that improve their cognitive, sensory and psychomotor skills should be used. In this context, with technological developments, various methods such as computer systems and simulation applications are becoming widespread in nursing education day by day.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in research,
- Not taking the Surgical Diseases Nursing course before,
- Not having received stoma care training before,
- Not having observed stoma care in previous applied courses
- Giving both written and verbal permission to participate in the research
Exclusion Criteria:
- Refusal to participate in the research,
- Receiving training on stoma care,
- Observing or performing stoma care before,
- Having a high school or associate degree related to the field of health
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
The control group will perform stoma care using the low-reality simulation (stoma model) method.
|
|
Experimental: Experimental group
Students in the experimental group will perform stoma care using high-reality simulation (3D printing and moulage) method.
|
Nursing students practice stoma care with low and high fidelity simulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge Level Evaluation Form Regarding Stoma Care
Time Frame: Pre-intervention and immediately after the intervention
|
Measuring stoma care knowledge
|
Pre-intervention and immediately after the intervention
|
Student Satisfaction and Self-Confidence Scale in Learning
Time Frame: Immediately after the intervention
|
Measuring satisfaction and self-confidence
|
Immediately after the intervention
|
Stoma Care Skill Grading Key
Time Frame: Immediately after the intervention
|
This tool consists of 23 items containing stoma care process steps.
In the Rubric, the adequacy is scored between 0-2 (0- Insufficient, 1- Partially adequate, 2- Sufficient) for each process step.
A minimum of 0 and a maximum of 46 points can be obtained from the Rubric.
The total score received from the Rubric indicates the adequacy of stoma care skills.
|
Immediately after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Ambe PC, Kurz NR, Nitschke C, Odeh SF, Moslein G, Zirngibl H. Intestinal Ostomy. Dtsch Arztebl Int. 2018 Mar 16;115(11):182-187. doi: 10.3238/arztebl.2018.0182.
- Bucknall TK, Forbes H, Phillips NM, Hewitt NA, Cooper S, Bogossian F; FIRST2ACT Investigators. An analysis of nursing students' decision-making in teams during simulations of acute patient deterioration. J Adv Nurs. 2016 Oct;72(10):2482-94. doi: 10.1111/jan.13009. Epub 2016 Jun 5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3D moulage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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