Stoma Care Knowledge and Skills of NursesNCT07061392
Stoma Education Methods and Nurse Learning Outcomes
A study testing standardized-patient simulation and a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model in people with Stoma Care Knowledge and Skills of Nurses and Simulation Based Learning, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled trial was to determine whether stoma-care training using standardized patients, as compared with low-fidelity mannequins, improved meaningful learning self-awareness, perceived learning, and practical stoma-care skill levels in oncology nurses at a 600-bed tertiary oncology… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stoma Care Knowledge and Skills of Nurses, Simulation Based Learning, Standardized Patient
- What is being tested?
- standardized-patient simulation and a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a nursing graduate
- Working as a nurse in an oncology hospital for at least one year
- Working in inpatient units
- Actively providing care to patients with ostomies
Who cannot join
- Holding a managerial position
- Having taken a course or received certification on stoma care within the last six months
- Being pregnant, on unpaid leave, or on sick leave
- Participating in another study during the same period
- Incomplete completion of the data collection form
- Voluntary withdrawal from the study during the research period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Ankara, 06560
About this study
Official title: The Effect of Stoma Education Given to Nurses With Two Different Methods on Their Meaningful Learning Self-Awareness, Perceived Learning and Stoma Care Skill Levels: A Randomized Controlled Experimental Study
The goal of this randomized controlled trial was to determine whether stoma-care training using standardized patients, as compared with low-fidelity mannequins, improved meaningful learning self-awareness, perceived learning, and practical stoma-care skill levels in oncology nurses at a 600-bed tertiary oncology education and research hospital in Ankara, Turkey. The main questions it aimed to answer were:
Did standardized-patient simulation produce greater gains in meaningful learning self-awareness?
Read more
Did it yield higher perceived learning scores?
Did it result in larger improvements in stoma-care skill levels?
Researchers compared Group M (standardized patient) to Group K (low-fidelity mannequin) to evaluate which method more effectively enhanced nurses' cognitive and technical outcomes.
Participants completed a 10-item demographic and background survey, answered pre-training assessments on all three scales, attended a two-hour didactic session on stoma fundamentals and evidence-based care, received two hours of hands-on practice with their assigned modality, and completed immediate post-training assessments using the same instruments.
- Conditions
- Stoma Care Knowledge and Skills of Nurses, Simulation Based Learning, Standardized Patient, Nurse, Self Awareness
- Being tested
- standardized-patient simulation, a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model
- Keywords
- stoma, nurses, self awarness, meaningful learning, clinical simulation, standardized patients, low reality model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized-patient simulationOther
Intervention Arm (Group M) Participants randomized to Group M (n = 45 enrolled; 43 analyzed) first completed baseline assessments of meaningful learning self-awareness , perceived learning, and stoma-care skill , as well as a 10-item demographic survey. They then attended a two-hour didactic session-covering stoma indications, types, perioperative care, evidence-based practices, complications, and the stoma-care nurse's role-delivered by a certified stoma-care nurse in small groups.
Immediately following the lecture, each nurse participated in a two-hour hands-on simulation with a trained standardized patient. The standardized patient had been prepared with a realistic stoma moulage (transparent drape and egg-biscuit mixture) and received two hours of role-training. Simulation sessions adhered to INACSL Standards ("pre-briefing," "in-scenario," "observation," and "debrief
a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma modelOther
Control Arm (Group K) Participants randomized to Group K (n = 45 enrolled; 44 analyzed) underwent the identical sequence of baseline assessments and the same two-hour didactic session as Group M. For the practical component, they performed stoma-care simulation on a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model.
Hands-on practice was structured in small groups over two hours and included:
Pre-briefing: Overview of objectives and materials.
In-scenario: Individual stoma-care performance on the mannequin, guided by the certified stoma-care nurse with cueing as needed.
Observation: Peers observed from a separate area with scenario summaries.
Debriefing: Reflection and feedback using the PEARLS framework to consolidate learning and discuss transfer to clinical practice.
Immediate post-training assessments using the same three scales captured outcomes in meaningful learning self-awareness, perceived learning, and stoma-care skill level.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Group M) | Experimental | Participants in Group M (45 enrolled; 43 analyzed) completed baseline assessments of meaningful learning self-awareness, perceived learning, stoma-care skills, and demographics. They attended a two-hour didactic session on stoma indications, perioperative care, and evidence-based practices. Immediately after, each nurse engaged in a two-hour standardized-patient simulation using realistic stoma moulage. Simulations followed INACSL standards, including a 15-minute pre-briefing, ~20-minute individual in-scenario practice with cueing, peer observation, and a 15-20-minute PEARLS debriefing. All outcome measures were repeated immediately post-training to evaluate short-term cognitive and technical gains. Receives: Other: a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model |
| Control Arm (Group K) | Experimental | Group K participants (n = 45 enrolled; 44 analyzed) completed baseline assessments of meaningful learning self-awareness, perceived learning, stoma-care skills, and demographics, and attended the same two-hour didactic session as Group M. They then performed a two-hour stoma-care simulation in small groups on a low-fidelity Prestan 2000 CPR mannequin fitted with a play-dough stoma model. Sessions followed INACSL structure: a brief pre-briefing of objectives and materials; individual mannequin practice with cueing; peer observation in an adjacent area; and a PEARLS-guided debriefing. Outcome measures were repeated immediately post-training to assess short-term cognitive and technical performance. Receives: Other: standardized-patient simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
practical stoma-care competence
- Meaningful Learning Self-Awareness Change in total and subscale scores on the 24-item Meaningful Learning Self-Awareness Scale, assessed before and immediately after training. The scale was administered as a self-report questionnaire. Higher post-training scores indicate increased awareness of metacognitive strategies and more effective transfer of learning.
- Perceived Learning Change in total and factor scores on the 9-item Perceived Learning Scale, administered before and immediately after training. The scale measures self-perceived learning in cognitive, emotional, and psychomotor domains. Higher post-training scores reflect increased perceived learning gains.
- Stoma-Care Skill Proficiency
Description:
Change in total scores on the 23-item Stoma Care Skill Rubric, based on direct observation before and immediately after training during simulated stoma-care performance. Higher post-training scores indicate improved technical competence in ostomy care.
Measured: At baseline and immediately after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Apr 2024
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma Care Knowledge and Skills of NursesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The goal of this randomized, parallel-group, assessor-blinded interventional trial was to determine whether stoma-care training using standardized patients, as compared with low-fidelity mannequins, produced superior gains in meaningful learning self-awareness, perceived learning, and practical stoma-care skill levels among oncology nurses at a 600-bed tertiary oncology education and research hospital in Ankara, Turkey. Key features of the interventional study model included: Design: Two-arm, parallel assignment, assessor-blinded randomized controlled trial. Randomization: Ninety nurses were allocated 1:1 to Group M (standardized patient) or Group K (low-fidelity mannequin) using simple block randomization with allocation concealment via sealed envelopes matched to a password-protected Excel list. Sample size and flow: Based on G\*Power analysis (effect size = 0.6, α = 0.05, β = 0.20), a minimum of 42 nurses per group was required; 45 were enrolled in each arm. After excluding those
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve BEKE, Istanbul University - Cerrahpasa
- Investigators
- Merve Beke, MsC, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061392
- Sponsor's protocol ID
- 2024-KAEK-07
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stoma Education Given to Nurses With Two Different Methods on Their Meaningful Learning Self-Awareness, Perceived Learning and Stoma Care Skill Levels: A Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT07061392
- Acronym / sponsor ID
- 2024-KAEK-07
- Conditions
- Stoma Care Knowledge and Skills of Nurses, Simulation Based Learning, Standardized Patient, Nurse, Self Awareness
- Keywords
- stoma, nurses, self awarness, meaningful learning, clinical simulation, standardized patients, low reality model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 11 Jul 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.
The goal of this randomized controlled trial was to determine whether stoma-care training using standardized patients, as compared with low-fidelity mannequins, improved meaningful learning self-awareness, perceived learning, and practical stoma-care skill levels in oncology nurses at a 600-bed tertiary oncology education and research hospital in Ankara, Turkey. The main questions it aimed to answer were:
Did standardized-patient simulation produce greater gains in meaningful learning self-awareness?
Did it yield higher perceived learning scores?
Did it result in larger improvements in stoma-care skill levels?
Researchers compared Group M (standardized patient) to Group K (low-fidelity mannequin) to evaluate which method more effectively enhanced nurses' cognitive and technical outcomes.
Participants completed a 10-item demographic and background survey, answered pre-training assessments on all three scales, attended a two-hour didactic session on stoma fundamentals and evidence-based care, received two hours of hands-on practice with their assigned modality, and completed immediate post-training assessments using the same instruments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The goal of this randomized, parallel-group, assessor-blinded interventional trial was to determine whether stoma-care training using standardized patients, as compared with low-fidelity mannequins, produced superior gains in meaningful learning self-awareness, perceived learning, and practical stoma-care skill levels among oncology nurses at a 600-bed tertiary oncology education and research hospital in Ankara, Turkey. Key features of the interventional study model included: Design: Two-arm, parallel assignment, assessor-blinded randomized controlled trial. Randomization: Ninety nurses were allocated 1:1 to Group M (standardized patient) or Group K (low-fidelity mannequin) using simple block randomization with allocation concealment via sealed envelopes matched to a password-protected Excel list. Sample size and flow: Based on G*Power analysis (effect size = 0.6, α = 0.05, β = 0.20), a minimum of 42 nurses per group was required; 45 were enrolled in each arm. After excluding those
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Group M) | Experimental | Other: a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma modelParticipants in Group M (45 enrolled; 43 analyzed) completed baseline assessments of meaningful learning self-awareness, perceived learning, stoma-care skills, and demographics. They attended a two-hour didactic session on stoma indications, perioperative care, and evidence-based practices. Immediately after, each nurse engaged in a two-hour standardized-patient simulation using realistic stoma moulage. Simulations followed INACSL standards, including a 15-minute pre-briefing, ~20-minute individual in-scenario practice with cueing, peer observation, and a 15-20-minute PEARLS debriefing. All outcome measures were repeated immediately post-training to evaluate short-term cognitive and technical gains. |
| Control Arm (Group K) | Experimental | Other: standardized-patient simulationGroup K participants (n = 45 enrolled; 44 analyzed) completed baseline assessments of meaningful learning self-awareness, perceived learning, stoma-care skills, and demographics, and attended the same two-hour didactic session as Group M. They then performed a two-hour stoma-care simulation in small groups on a low-fidelity Prestan 2000 CPR mannequin fitted with a play-dough stoma model. Sessions followed INACSL structure: a brief pre-briefing of objectives and materials; individual mannequin practice with cueing; peer observation in an adjacent area; and a PEARLS-guided debriefing. Outcome measures were repeated immediately post-training to assess short-term cognitive and technical performance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being a nursing graduate
- Working as a nurse in an oncology hospital for at least one year
- Working in inpatient units
- Actively providing care to patients with ostomies
Key exclusion criteria (6 listed)
- Holding a managerial position
- Having taken a course or received certification on stoma care within the last six months
- Being pregnant, on unpaid leave, or on sick leave
- Participating in another study during the same period
- Incomplete completion of the data collection form
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 |
|---|---|---|
| standardized-patient simulationIntervention Arm (Group M) Participants randomized to Group M (n = 45 enrolled; 43 analyzed) first completed baseline assessments of meaningful learning self-awareness , perceived learning, and stoma-care skill , as well as a 10-item demographic survey. They then attended a two-hour didactic session-covering stoma indications, types, perioperative care, evidence-based practices, complications, and the stoma-care nurse's role-delivered by a certified stoma-care nurse in small groups. Immediately following the lecture, each nurse participated in a two-hour hands-on simulation with a trained standardized patient. The standardized patient had been prepared with a realistic stoma moulage (transparent drape and egg-biscuit mixture) and received two hours of role-training. Simulation sessions adhered to INACSL Standards ("pre-briefing," "in-scenario," "observation," and "debrief | Other | Control Arm (Group K) |
| a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma modelControl Arm (Group K) Participants randomized to Group K (n = 45 enrolled; 44 analyzed) underwent the identical sequence of baseline assessments and the same two-hour didactic session as Group M. For the practical component, they performed stoma-care simulation on a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model. Hands-on practice was structured in small groups over two hours and included: Pre-briefing: Overview of objectives and materials. In-scenario: Individual stoma-care performance on the mannequin, guided by the certified stoma-care nurse with cueing as needed. Observation: Peers observed from a separate area with scenario summaries. Debriefing: Reflection and feedback using the PEARLS framework to consolidate learning and discuss transfer to clinical practice. Immediate post-training assessments using the same three scales captured outcomes in meaningful learning self-awareness, perceived learning, and stoma-care skill level. | Other | Intervention Arm (Group M) |
Primary outcome
practical stoma-care competence
Time frame: At baseline and immediately after training
1. Meaningful Learning Self-Awareness Change in total and subscale scores on the 24-item Meaningful Learning Self-Awareness Scale, assessed before and immediately after training. The scale was administered as a self-report questionnaire. Higher post-training scores indicate increased awareness of metacognitive strategies and more effective transfer of learning. 2. Perceived Learning Change in total and factor scores on the 9-item Perceived Learning Scale, administered before and immediately after training. The scale measures self-perceived learning in cognitive, emotional, and psychomotor domains. Higher post-training scores reflect increased perceived learning gains. 3. Stoma-Care Skill Proficiency Description: Change in total scores on the 23-item Stoma Care Skill Rubric, based on direct observation before and immediately after training during simulated stoma-care performance. Higher post-training scores indicate improved technical competence in ostomy care.
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 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Stoma Care Knowledge and Skills of Nurses
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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.
Merve Beke, MsC principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized-patient simulation and a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model in people with Stoma Care Knowledge and Skills of Nurses and Simulation Based Learning, run by Istanbul University - Cerrahpasa 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 4 inclusion and 6 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 15 Jul 2025. 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?
practical stoma-care competence (time frame: At baseline and immediately after training). 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 15 Jul 2025.