CClinicalTrials.gg
Not yet recruitingNCT06326398Updated Mar 25, 2024

The Effect of Using 3D Printers and Moulage on Improving Stoma Care

An interventional study of Stoma Care in Stoma Colostomy, sponsored by Namik Kemal University. Not yet recruiting. Open to participants aged 18 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by Namik Kemal University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 22 Years
Sex
All
01

Study summary

When studies in the literature are examined, there are studies in which various methods are applied to students' stoma care knowledge and skills. Additionally, it is seen that there are studies using moulage or 3D printers as simulation applications in nursing education. However, there is no study on high-reality simulation application using 3D printer and moulage technique together.nIn this research, the effect of the stoma created with a 3D printer in a high-reality simulation on the stoma care knowledge and skills, satisfaction and self-confidence of nursing students will be examined by using the moulage technique. In addition, this application will be compared with nursing students' stoma care practices in the stoma model, which is classified as low-reality simulation. We think that our project will be unique in this field, as it uses current technological methods together in this planned research and is different from similar studies.

Read the 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.

02

Conditions studied

  • Stoma Colostomy

Keywords

  • stoma
  • nursing student
  • 3d printer
  • moulage
03

In context

Lead sponsor

Namik Kemal University is the lead sponsor of 57 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
76 participants (estimated)

Study arms

  • 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.

    Other: Stoma Care

Interventions

  • OtherStoma Care

    Nursing students practice stoma care with low and high fidelity simulation

06

What researchers measure

Primary outcomes

  1. Knowledge Level Evaluation Form Regarding Stoma Care

    Measuring stoma care knowledge

    Time frame: Pre-intervention and immediately after the intervention

  2. Stoma Care Skill Grading Key

    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.

    Time frame: Immediately after the intervention

  3. Student Satisfaction and Self-Confidence Scale in Learning

    Measuring satisfaction and self-confidence

    Time frame: Immediately after the intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 29607805 ↗
  • 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. PubMed 27265550 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06326398
Lead sponsor
Namik Kemal University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Tülin YILDIZ (Prof. Dr., Namik Kemal University) — Principal investigator
First posted
Mar 22, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
May 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Mar 25, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion