Stoma ColostomyNCT06326398
The Effect of Using 3D Printers and Moulage on Improving Stoma Care
A study testing Stoma Care in people with Stoma Colostomy, run by Namik Kemal University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Stoma Colostomy
- What is being tested?
- Stoma Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effect of Using 3D Printers and Moulage on Improving Stoma Care Knowledge and Skills in Nursing Students
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.
- Conditions
- Stoma Colostomy
- Being tested
- Stoma Care
- Keywords
- stoma, nursing student, 3d printer, moulage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma CareOther
Nursing students practice stoma care with low and high fidelity simulation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will perform stoma care using the low-reality simulation (stoma model) method. |
| Experimental group | Experimental | Students in the experimental group will perform stoma care using high-reality simulation (3D printing and moulage) method. Receives: Other: Stoma Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Level Evaluation Form Regarding Stoma Care
Measuring stoma care knowledge
Measured: Pre-intervention and immediately after the intervention
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.
Measured: Immediately after the intervention
Student Satisfaction and Self-Confidence Scale in Learning
Measuring satisfaction and self-confidence
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Tülin YILDIZ, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326398
- Sponsor's protocol ID
- 3D moulage
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 29607805Bucknall 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using 3D Printers and Moulage on Improving Stoma Care Knowledge and Skills in Nursing Students
- ClinicalTrials.gov ID
- NCT06326398
- Acronym / sponsor ID
- 3D moulage
- Conditions
- Stoma Colostomy
- Keywords
- stoma, nursing student, 3d printer, moulage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will perform stoma care using the low-reality simulation (stoma model) method. |
| Experimental group | Experimental | Other: Stoma CareStudents in the experimental group will perform stoma care using high-reality simulation (3D printing and moulage) method. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stoma CareNursing students practice stoma care with low and high fidelity simulation | Other | Experimental group |
Primary outcome
Knowledge Level Evaluation Form Regarding Stoma Care
Time frame: Pre-intervention and immediately after the intervention
Measuring stoma care knowledge
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.
Student Satisfaction and Self-Confidence Scale in Learning
Time frame: Immediately after the intervention
Measuring satisfaction and self-confidence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 29607805Ambe 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.
- Background: PubMed 27265550Bucknall 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.
- 12\. International Agency for Research on Cancer (IARC), 2020. "Cancer Today"Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stoma Care in people with Stoma Colostomy, run by Namik Kemal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Level Evaluation Form Regarding Stoma Care (time frame: Pre-intervention and immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.