StomaSIMESEPNCT06749769
Simulation-Based Learning Experience in Strengthening Stoma Care Education
A study testing simulation-based education in people with Stoma, run by Nuran Ayşen Pamir Aksoy at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the effectiveness of simulation-based learning experience in enhancing stoma care education on patients with stoma. The main hypothesis it aims to test are: H1: Simulation-based learning experience is effective in reducing stoma patients' concerns about performing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma
- What is being tested?
- simulation-based education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Apr 2026to Dec 2026
- 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
- Age 18 and above
- First time having a stoma and having an intestinal stoma,
- Communicable, open to cooperation,
- Able to speak and understand Turkish,
- Individuals who are willing to participate in the research and willing to be interviewed will be included in the research.
Who cannot join
- Patients who develop surgical complications in their stoma.
- Patients who are unable to perform stoma care due to any complication
- Having previously received stoma care training or participated in its implementation for any reason
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acibadem Altunizade Hospital
Istanbul, Other, 34752
Acibadem Atakent Hospital
Istanbul, Other, 34752
About this study
Official title: Investigation of the Effectiveness of Simulation-Based Learning Experience in Strengthening Stoma Care Education on Patients With Stoma
The goal of this clinical trial is to investigate the effectiveness of simulation-based learning experience in enhancing stoma care education on patients with stoma.
The main hypothesis it aims to test are:
Read more
H1: Simulation-based learning experience is effective in reducing stoma patients' concerns about performing stoma care.
H2: Simulation-based learning experience is effective in increasing stoma patients' stoma care skills.
H3: Simulation-based learning experience is effective in increasing stoma patients' perceived self-efficacy regarding stoma care.
Researchers will compare the control and study group to see if the simulation-based learning enhances the patients learning experience.
Participants will be asked to;
- Answer the questions (demographic data form and anxiety scale)
- Receive education regarding stoma care (verbal and demonstration)
- Practice stoma care on their own
- Conditions
- Stoma
- Being tested
- simulation-based education
- Keywords
- stoma care, patient education, simulation, patient's learning experience, Strengthening patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation-based educationBehavioural
Patients will learn how to care for their stomata on a stoma simulator
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in the control group will receive routine verbal instructions and demonstration education about their stoma care. |
| Study Group | Experimental | Participants in this group will receive a simulation-based stoma care education. Receives: Behavioral: simulation-based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma Care Skills Rubric
It consists of 23 items that include stoma care process steps. The learner's competence for each process step is scored between 0-2 (0- Insufficient 1- Partially sufficient 2- Sufficient). A minimum of 0 and a maximum of 46 points can be obtained. The total score shows the competence of stoma care skills.
Measured: Post-operative 3rd day
Generalized Perceived Self-Efficacy Scale
It consists of 10 items, and each item of the scale is scored between 1 and 4. These are listed as not true (1), somewhat true (2), more true (3), and completely true (4). Minimum of 10 and a maximum of 40 points can be obtained. The higher the score, the higher the individual's perceived self-efficacy.
Measured: at the time of enrollement, and Post-operative 3rd day
Secondary outcomes (1)
State Anxiety Level
In the study, the state anxiety scale will be used to determine the anxiety levels of the patients during the application. The State Anxiety Scale (SAS) provides information about what the individual feels at that moment. The State Anxiety Scale is a Likert-type scale consisting of 20 items, rated between 1 (not at all) and 4 (completely).
Measured: at the time of enrollement, and post-operative 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Due to changes in the clinical research team. The surgeon responsible for performing the study-related procedures has left the study hospital. The research team is currently seeking an appropriately qualified investigator to resume the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomaStudies 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
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuran Ayşen Pamir Aksoy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nuran Ayşen Pamir Aksoy, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749769
- Sponsor's protocol ID
- 2024-17/648
- Acronym
- SIMESEP
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Simulation-Based Learning Experience in Strengthening Stoma Care Education on Patients With Stoma
- ClinicalTrials.gov ID
- NCT06749769
- Acronym / sponsor ID
- SIMESEP / 2024-17/648
- Conditions
- Stoma
- Keywords
- stoma care, patient education, simulation, patient's learning experience, Strengthening patients
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to changes in the clinical research team. The surgeon responsible for performing the study-related procedures has left the study hospital. The research team is currently seeking an appropriately qualified investigator to resume the study.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nuran Ayşen Pamir AksoyUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Dec 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.
The goal of this clinical trial is to investigate the effectiveness of simulation-based learning experience in enhancing stoma care education on patients with stoma.
The main hypothesis it aims to test are:
H1: Simulation-based learning experience is effective in reducing stoma patients' concerns about performing stoma care.
H2: Simulation-based learning experience is effective in increasing stoma patients' stoma care skills.
H3: Simulation-based learning experience is effective in increasing stoma patients' perceived self-efficacy regarding stoma care.
Researchers will compare the control and study group to see if the simulation-based learning enhances the patients learning experience.
Participants will be asked to;
- Answer the questions (demographic data form and anxiety scale)
- Receive education regarding stoma care (verbal and demonstration)
- Practice stoma care on their own
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in the control group will receive routine verbal instructions and demonstration education about their stoma care. |
| Study Group | Experimental | Behavioral: simulation-based educationParticipants in this group will receive a simulation-based stoma care education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and above
- First time having a stoma and having an intestinal stoma,
- Communicable, open to cooperation,
- Able to speak and understand Turkish,
- Individuals who are willing to participate in the research and willing to be interviewed will be included in the research.
Key exclusion criteria (3 listed)
- Patients who develop surgical complications in their stoma.
- Patients who are unable to perform stoma care due to any complication
- Having previously received stoma care training or participated in its implementation for any reason
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 |
|---|---|---|
| simulation-based educationPatients will learn how to care for their stomata on a stoma simulator | Behavioural | Study Group |
Primary outcome
Stoma Care Skills Rubric
Time frame: Post-operative 3rd day
It consists of 23 items that include stoma care process steps. The learner's competence for each process step is scored between 0-2 (0- Insufficient 1- Partially sufficient 2- Sufficient). A minimum of 0 and a maximum of 46 points can be obtained. The total score shows the competence of stoma care skills.
Generalized Perceived Self-Efficacy Scale
Time frame: at the time of enrollement, and Post-operative 3rd day
It consists of 10 items, and each item of the scale is scored between 1 and 4. These are listed as not true (1), somewhat true (2), more true (3), and completely true (4). Minimum of 10 and a maximum of 40 points can be obtained. The higher the score, the higher the individual's perceived self-efficacy.
1 secondary outcome
State Anxiety Level
Time frame: at the time of enrollement, and post-operative 3rd day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation-based education in people with Stoma, run by Nuran Ayşen Pamir Aksoy at 2 sites 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: paused, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Stoma Care Skills Rubric (time frame: Post-operative 3rd day). 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 12 Jan 2026.