Simulation-based LearningNCT06826404
High-fidelity Simulators and Standardized Patients on the Stoma Care
A study testing Training provided with a wearable ostomy model and standardized patient and Training low fidelity simulator in people with Simulation-based Learning and Nursing Students, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This is a randomized controlled study to investigate the effects of skill training on a low-fidelity simulator with a standardized patient using a wearable ostomy model on the stoma care skills and satisfaction levels of nursing students. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Simulation-based Learning, Nursing Students, Ostomy
- What is being tested?
- Training provided with a wearable ostomy model and standardized patient and Training low fidelity simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successfully completing the Internal Medicine Nursing course
- Taking the Surgical Disease Nursing course
- Not having any absences from the 7th week (the week when the
- Gastrointestinal System Surgery topic is covered)
- Participating in the study process completely
Who cannot join
- Retaking Surgical Nursing course due to failure
- Participating in a different skill course related to stoma care
- Having provided stoma care at any time before
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Aydin, Efeler, 09010
About this study
Official title: The Effects of Using High-fidelity Simulators and Standardized Patients on the Stoma Care Skills and Learning Satisfaction Level on Nursing Students: A Randomized Controlled Trial
This is a randomized controlled study to investigate the effects of skill training on a low-fidelity simulator with a standardized patient using a wearable ostomy model on the stoma care skills and satisfaction levels of nursing students.
Read the detailed description
Phase 1: Design of wearable colostomy model The wearable colostomy model to be designed within the scope of the project will be soft, skin-sensitive, in accordance with the real anatomy and will have wearable qualities with the help of hanger-velcro tape. There will be one healthy and normal-looking stoma on the model. The velcro tape system of the model will be made of elastic and adjustable velcro tapes according to waist measurements and will be placed on the back of the belt. The width of the tape system will be 5 cm and the length will be 90 cm. The hooked part of the velcro tapes will be fixed to one end of the elastic belt and the looped part will be fixed to the other end, the looped part will be kept longer and the belt will be adjustable at different lengths. The velcro tapes will be placed on the fabric and will be joined by sewing. On this system, a soft skin-colored medical silicone human skin will be made by sewing or gluing the abdominal surface. A dark pink stoma appearance will be created on this abdominal surface, with a diameter of 2.5 cm, slightly raised and natural from the skin surface. Modeling clay will be used to create this appearance.
Phase 2: Wearable colostomy model stoma care training What is a stoma, nursing care after stoma surgery, peristomal area care will be explained to the students participating in the study theoretically by the responsible facilitator in one session and for a maximum of 30 minutes with plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the facilitator of the study based on literature will be developed. This guide will be sent to 5 academicians who are experts in the field of Surgical Disease Nursing, expert opinions will be received and the skill learning guide will be finalized in line with the opinions received. According to the skill steps in this learning guide, the researcher will perform stoma care on a wearable colostomy model by a volunteer student who is doing her doctorate in Surgical Diseases Nursing and will provide nursing students with the opportunity to ask questions, then she will be provided with the opportunity to demonstrate the skill on the wearable stoma model twice by following the steps in the learning guide. The same process will be performed with the other group on an inanimate mannequin and with the same steps. In the study, one group will perform the skill with a wearable ostomy model, while the other group will teach the skill on an inanimate mannequin with an ostomy. Skill teaching will be planned on different days and times, and the level of interaction between the groups regarding the skill teaching will be minimized.
Phase 3: Evaluation of nursing students' stoma care skills, satisfaction with the simulation experience and their recommendations All students will perform the skill on a standard patient with a wearable ostomy model. This process will be conducted by an independent researcher. This scoring and evaluation will take place in a laboratory environment. After scoring, the simulation experience satisfaction scale will be given to the students and they will be asked to fill it out.
- Conditions
- Simulation-based Learning, Nursing Students, Ostomy
- Being tested
- Training provided with a wearable ostomy model and standardized patient, Training low fidelity simulator
- Keywords
- Nursing students, Simulation, Ostomy care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training provided with a wearable ostomy model and standardized patientDevice
The subjects of what is stoma, nursing care after stoma surgery, and care of the peristomal area will be explained to the students participating in the study theoretically by the responsible director in a session and for a maximum of 30 minutes with plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, stoma care will be performed on a wearable colostomy model by a volunteer student who is doing her doctorate in Surgical Diseases Nursing in accordance with the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the director of the study based on literature, and nursing students will be given the opportunity to ask questions, and then the skill will be demonstrated twice on the wearable stoma model by following the steps in the learning guide.
Training low fidelity simulatorOther
The subjects of what is stoma, nursing care after stoma surgery, and care of the peristomal area will be explained to the students participating in the study theoretically by the responsible facilitator in one session and for a maximum of 30 minutes, using plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, skill training will be carried out on a lifeless mannequin in accordance with the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the facilitator of the study based on literature.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Standardized patient with weareble ostomy model) | Experimental | The study group will be taught stoma care skills with a standardized patient wearing a wearable ostomy model. Receives: Device: Training provided with a wearable ostomy model and standardized patient |
| Control group (Low fidelity simulator) | Active comparator | The study group will be taught stoma care skills with a low fidelity simulator. Receives: Other: Training low fidelity simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma care skill points
The key developed by İncesu and his colleagues consists of 23 items. The items in the key include the gradual steps of stoma care such as explaining the procedure to the patient, preparing the materials, and protecting privacy regarding the students' stoma care skills. The key is planned as 'insufficient' (0 points) if the practitioner cannot perform the application by observing the student or does it wrong, 'partially sufficient' (1 point) if the step is applied correctly but in the wrong order, and 'sufficient' (2 points) if the step is applied correctly and in the wrong order. The minimum score to be obtained from the key is 0, and the maximum score is 46. Although there is no cut-off value for the scale, it is interpreted that the care skill increases as the score obtained increases. The scale will be applied once by an independent evaluator after the skill training for all students.
Measured: Within 3 weeks after stoma care skill teaching
Simulation experience satisfaction level
The scale developed by Tüzer and his colleagues consists of three sub-dimensions: analysis and reflection, clinical reasons and clinical learning. The total number of items in the scale is 18. The responses to be given for each item are scored as strongly disagree, disagree, not sure, agree, strongly agree. Although there is no cut-off value for the scale, it is interpreted that as the score increases, the level of satisfaction increases. After the simulation evaluation process is completed, students will fill out the scale once based on their self-reports.
Measured: Within 3 weeks after stoma care skill teaching
Secondary outcomes (1)
Recommendation score
The ostomy model developed for this study was created for recommendation scores regarding its use in simulation training. A scoring system will be used to evaluate students' stoma care skill teaching with a wearable ostomy model from 0 to 10. As the student's score increases, it will be interpreted that the model's usability in teaching stoma care skills is high.
Measured: Within 3 weeks after stoma care skill teaching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start15 Mar 2025
- Primary completion15 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation-based LearningStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nursing students who were to be taught stoma care skills with a standardized patient vs. low-fidelity simulator included in the study were randomly assigned to a study and a control group (1:1 randomization).
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Arslan, Aydin Adnan Menderes University
- Investigators
- Ezgi Arslan, PhD, Principal investigator, DirectorHavva Yönem Amaç, PhD, Study chair, ResearcherSultan Özkan, PhD, Study chair, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826404
- Sponsor's protocol ID
- Wearable Ostomy Model
- Status last verified
- May 2025
- First submitted
- 7 Feb 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using High-fidelity Simulators and Standardized Patients on the Stoma Care Skills and Learning Satisfaction Level on Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06826404
- Acronym / sponsor ID
- Wearable Ostomy Model
- Conditions
- Simulation-based Learning, Nursing Students, Ostomy
- Keywords
- Nursing students, Simulation, Ostomy care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 14 Feb 2025 (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.
This is a randomized controlled study to investigate the effects of skill training on a low-fidelity simulator with a standardized patient using a wearable ostomy model on the stoma care skills and satisfaction levels of nursing students.
Detailed description
Phase 1: Design of wearable colostomy model The wearable colostomy model to be designed within the scope of the project will be soft, skin-sensitive, in accordance with the real anatomy and will have wearable qualities with the help of hanger-velcro tape. There will be one healthy and normal-looking stoma on the model. The velcro tape system of the model will be made of elastic and adjustable velcro tapes according to waist measurements and will be placed on the back of the belt. The width of the tape system will be 5 cm and the length will be 90 cm. The hooked part of the velcro tapes will be fixed to one end of the elastic belt and the looped part will be fixed to the other end, the looped part will be kept longer and the belt will be adjustable at different lengths. The velcro tapes will be placed on the fabric and will be joined by sewing. On this system, a soft skin-colored medical silicone human skin will be made by sewing or gluing the abdominal surface. A dark pink stoma appearance will be created on this abdominal surface, with a diameter of 2.5 cm, slightly raised and natural from the skin surface. Modeling clay will be used to create this appearance.
Phase 2: Wearable colostomy model stoma care training What is a stoma, nursing care after stoma surgery, peristomal area care will be explained to the students participating in the study theoretically by the responsible facilitator in one session and for a maximum of 30 minutes with plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the facilitator of the study based on literature will be developed. This guide will be sent to 5 academicians who are experts in the field of Surgical Disease Nursing, expert opinions will be received and the skill learning guide will be finalized in line with the opinions received. According to the skill steps in this learning guide, the researcher will perform stoma care on a wearable colostomy model by a volunteer student who is doing her doctorate in Surgical Diseases Nursing and will provide nursing students with the opportunity to ask questions, then she will be provided with the opportunity to demonstrate the skill on the wearable stoma model twice by following the steps in the learning guide. The same process will be performed with the other group on an inanimate mannequin and with the same steps. In the study, one group will perform the skill with a wearable ostomy model, while the other group will teach the skill on an inanimate mannequin with an ostomy. Skill teaching will be planned on different days and times, and the level of interaction between the groups regarding the skill teaching will be minimized.
Phase 3: Evaluation of nursing students' stoma care skills, satisfaction with the simulation experience and their recommendations All students will perform the skill on a standard patient with a wearable ostomy model. This process will be conducted by an independent researcher. This scoring and evaluation will take place in a laboratory environment. After scoring, the simulation experience satisfaction scale will be given to the students and they will be asked to fill it out.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nursing students who were to be taught stoma care skills with a standardized patient vs. low-fidelity simulator included in the study were randomly assigned to a study and a control group (1:1 randomization).
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Standardized patient with weareble ostomy model) | Experimental | Device: Training provided with a wearable ostomy model and standardized patientThe study group will be taught stoma care skills with a standardized patient wearing a wearable ostomy model. |
| Control group (Low fidelity simulator) | Active comparator | Other: Training low fidelity simulatorThe study group will be taught stoma care skills with a low fidelity simulator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Successfully completing the Internal Medicine Nursing course
- Taking the Surgical Disease Nursing course
- Not having any absences from the 7th week (the week when the
- Gastrointestinal System Surgery topic is covered)
- Participating in the study process completely
Key exclusion criteria (3 listed)
- Retaking Surgical Nursing course due to failure
- Participating in a different skill course related to stoma care
- Having provided stoma care at any time before
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 |
|---|---|---|
| Training provided with a wearable ostomy model and standardized patientThe subjects of what is stoma, nursing care after stoma surgery, and care of the peristomal area will be explained to the students participating in the study theoretically by the responsible director in a session and for a maximum of 30 minutes with plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, stoma care will be performed on a wearable colostomy model by a volunteer student who is doing her doctorate in Surgical Diseases Nursing in accordance with the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the director of the study based on literature, and nursing students will be given the opportunity to ask questions, and then the skill will be demonstrated twice on the wearable stoma model by following the steps in the learning guide. | Device | Intervention group (Standardized patient with weareble ostomy model) |
| Training low fidelity simulatorThe subjects of what is stoma, nursing care after stoma surgery, and care of the peristomal area will be explained to the students participating in the study theoretically by the responsible facilitator in one session and for a maximum of 30 minutes, using plain narration and discussion methods, not exceeding 30 slides. Both groups will receive this training at the same time. After this explanation, skill training will be carried out on a lifeless mannequin in accordance with the skill guide "Changing the Ostomy Bag and Nursing Care of the Peristomal Area" developed by the facilitator of the study based on literature. | Other | Control group (Low fidelity simulator) |
Primary outcome
Stoma care skill points
Time frame: Within 3 weeks after stoma care skill teaching
The key developed by İncesu and his colleagues consists of 23 items. The items in the key include the gradual steps of stoma care such as explaining the procedure to the patient, preparing the materials, and protecting privacy regarding the students' stoma care skills. The key is planned as 'insufficient' (0 points) if the practitioner cannot perform the application by observing the student or does it wrong, 'partially sufficient' (1 point) if the step is applied correctly but in the wrong order, and 'sufficient' (2 points) if the step is applied correctly and in the wrong order. The minimum score to be obtained from the key is 0, and the maximum score is 46. Although there is no cut-off value for the scale, it is interpreted that the care skill increases as the score obtained increases. The scale will be applied once by an independent evaluator after the skill training for all students.
Simulation experience satisfaction level
Time frame: Within 3 weeks after stoma care skill teaching
The scale developed by Tüzer and his colleagues consists of three sub-dimensions: analysis and reflection, clinical reasons and clinical learning. The total number of items in the scale is 18. The responses to be given for each item are scored as strongly disagree, disagree, not sure, agree, strongly agree. Although there is no cut-off value for the scale, it is interpreted that as the score increases, the level of satisfaction increases. After the simulation evaluation process is completed, students will fill out the scale once based on their self-reports.
1 secondary outcome
Recommendation score
Time frame: Within 3 weeks after stoma care skill teaching
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Ezgi Arslan, PhD principal investigator
Director
Havva Yönem Amaç, PhD study chair
Researcher
Sultan Özkan, PhD study chair
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training provided with a wearable ostomy model and standardized patient and Training low fidelity simulator in people with Simulation-based Learning and Nursing Students, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stoma care skill points (time frame: Within 3 weeks after stoma care skill teaching). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.