Colostomy StomaNCT07559578
The Effects of Colostomy Care Training Based on Jeffries' Simulation Theory on Nursing Students
A study testing Standardized Patient Simulation Group in people with Colostomy Stoma, run by Aybike Cici at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of colostomy care training based on Jeffries' Simulation Theory on nursing students' knowledge, skills, stress, self-efficacy, readiness, state anxiety, satisfaction, and self-confidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy Stoma
- What is being tested?
- Standardized Patient Simulation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2026to 16 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Volunteering to participate in the study,
- Being a fourth-year nursing student,
- Being enrolled in the HEM-402 course.
Who cannot join
- Being a nurse working in the clinic,
- Not participating in the training programme,
- Not wishing to continue with the research, wishing to withdraw from the research at any stage
- Incomplete or incorrect completion of data collection tools
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kafkas University Faculty of Health Sciences
Kars, Central, 36100
Aybike Cici, 05388759987, aybkmrv97@gmail.com
About this study
Official title: The Effects of Colostomy Care Training Based on Jeffries' Simulation Theory on Nursing Students: A Randomised Controlled Study
The aim of this study is to examine the effect of colostomy care training based on Jeffries' Simulation Theory on nursing students' knowledge, skills, stress, self-efficacy, readiness, state anxiety, satisfaction, and self-confidence.
The study seeks to answer the following hypotheses: H1: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' knowledge levels. H2: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' skill levels. H3: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' stress levels. H4: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' self-efficacy levels. H5: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' preparedness levels. H6: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' levels of situational anxiety. H7: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' levels of learning satisfaction and self-confidence. According to the Colostomy Care Training Booklet prepared by the researchers, all students will receive training on colostomy care procedures. Students in the intervention group will be individually taken to the simulation laboratory for colostomy care applications using moulage on standardized (simulated) patients, and they will be asked to perform the skills acquired during the training. The effectiveness of this intervention will be evaluated by comparing the intervention group with a control group. Participants: Students in the standardized patient simulation group will perform colostomy bag change and colostomy care skills in the simulation laboratory. Students in the low-fidelity simulation group (control group) will perform colostomy bag change and colostomy care skills using a low-fidelity patient model.
- Conditions
- Colostomy Stoma
- Being tested
- Standardized Patient Simulation Group
- Keywords
- Readiness, colostomy, care, self-sufficiency, self-confidence, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Patient Simulation GroupBehavioural
Students in the intervention group will be taken individually to the simulation laboratory for colostomy care procedures created with mannequins for standard (simulated) patients, and will be asked to apply the skills acquired during training.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Patient Simulation Group | Experimental | Not described Receives: Behavioral: Standardized Patient Simulation Group |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colostomy care training based on Jeffries' Simulation Theory provided to nursing students leads to changes in knowledge level scores.
Colostomy Care Knowledge Assessment Test: The score obtained from the scale ranges from 0 to 100 points. As the score increases, the level of knowledge increases.
Measured: within one week of the simulation exercise
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in skill scores.
Colostomy Care Skills Assessment Form: The score ranges from 0 to 100. As the score increases, so does the level of skill.
Measured: within one week of the simulation exercise
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in stress level scores.
Stress Perception Scale for Nursing Students: The total score on the scale ranges from 0 to 116. A high score on the scale indicates a high level of stress.
Measured: within one week of the simulation exercise
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in their self-efficacy scores.
Self-Efficacy Scale for Clinical Assessment: The lowest possible mean item score on the scale is 0, and the highest is 100. A high score on the scale indicates a high level of self-efficacy regarding clinical performance, whilst a low score indicates a low level of self-efficacy regarding clinical performance.
Measured: within one week of the simulation exercise
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in readiness scores.
Casey-Fink Readiness for Practice Scale: The minimum score on the scale is 15 and the maximum is 60. As the score on the scale increases, students' level of readiness for practice increases.
Measured: within one week of the simulation exercise
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in state anxiety scores.
State-Trait Anxiety Inventory: Scores on the scale range from 20 to 80. A higher score indicates a higher level of anxiety, whilst a lower score indicates a lower level of anxiety.
Measured: within one week of the simulation exercise
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in student satisfaction and self-confidence levels in learning.
Student Satisfaction and Self-Confidence Scale in Learning: The sum of the scale's sub-dimensions does not yield the total scale score; scores are obtained by dividing the sum of the sub-dimension items by the number of items in the relevant sub-dimension. As the score obtained from the scale increases, students' satisfaction with learning and self-confidence also increase.
Measured: within one week of the simulation exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start16 Mar 2026
- Primary completion16 May 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aybike Cici
- Sponsor type
- University, hospital or other
- Collaborators
- Kafkas University
- Responsible party
- Sponsor-investigator, Aybike Cici, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559578
- Sponsor's protocol ID
- 1829502.903/144
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Colostomy Care Training Based on Jeffries' Simulation Theory on Nursing Students: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07559578
- Acronym / sponsor ID
- 1829502.903/144
- Conditions
- Colostomy Stoma
- Keywords
- Readiness, colostomy, care, self-sufficiency, self-confidence, simulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Aybike CiciUniversity, hospital or other
- Collaborators
- Kafkas University
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 16 May 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 30 Apr 2026 (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 aim of this study is to examine the effect of colostomy care training based on Jeffries' Simulation Theory on nursing students' knowledge, skills, stress, self-efficacy, readiness, state anxiety, satisfaction, and self-confidence.
The study seeks to answer the following hypotheses: H1: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' knowledge levels. H2: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' skill levels. H3: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' stress levels. H4: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' self-efficacy levels. H5: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' preparedness levels. H6: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' levels of situational anxiety. H7: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' levels of learning satisfaction and self-confidence. According to the Colostomy Care Training Booklet prepared by the researchers, all students will receive training on colostomy care procedures. Students in the intervention group will be individually taken to the simulation laboratory for colostomy care applications using moulage on standardized (simulated) patients, and they will be asked to perform the skills acquired during the training. The effectiveness of this intervention will be evaluated by comparing the intervention group with a control group. Participants: Students in the standardized patient simulation group will perform colostomy bag change and colostomy care skills in the simulation laboratory. Students in the low-fidelity simulation group (control group) will perform colostomy bag change and colostomy care skills using a low-fidelity patient model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Patient Simulation Group | Experimental | Behavioral: Standardized Patient Simulation Group |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the study,
- Being a fourth-year nursing student,
- Being enrolled in the HEM-402 course.
Key exclusion criteria (4 listed)
- Being a nurse working in the clinic,
- Not participating in the training programme,
- Not wishing to continue with the research, wishing to withdraw from the research at any stage
- Incomplete or incorrect completion of data collection tools
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 Simulation GroupStudents in the intervention group will be taken individually to the simulation laboratory for colostomy care procedures created with mannequins for standard (simulated) patients, and will be asked to apply the skills acquired during training. | Behavioural | Standardized Patient Simulation Group |
Primary outcome
Colostomy care training based on Jeffries' Simulation Theory provided to nursing students leads to changes in knowledge level scores.
Time frame: within one week of the simulation exercise
Colostomy Care Knowledge Assessment Test: The score obtained from the scale ranges from 0 to 100 points. As the score increases, the level of knowledge increases.
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in skill scores.
Time frame: within one week of the simulation exercise
Colostomy Care Skills Assessment Form: The score ranges from 0 to 100. As the score increases, so does the level of skill.
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in stress level scores.
Time frame: within one week of the simulation exercise
Stress Perception Scale for Nursing Students: The total score on the scale ranges from 0 to 116. A high score on the scale indicates a high level of stress.
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in their self-efficacy scores.
Time frame: within one week of the simulation exercise
Self-Efficacy Scale for Clinical Assessment: The lowest possible mean item score on the scale is 0, and the highest is 100. A high score on the scale indicates a high level of self-efficacy regarding clinical performance, whilst a low score indicates a low level of self-efficacy regarding clinical performance.
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in readiness scores.
Time frame: within one week of the simulation exercise
Casey-Fink Readiness for Practice Scale: The minimum score on the scale is 15 and the maximum is 60. As the score on the scale increases, students' level of readiness for practice increases.
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in state anxiety scores.
Time frame: within one week of the simulation exercise
State-Trait Anxiety Inventory: Scores on the scale range from 20 to 80. A higher score indicates a higher level of anxiety, whilst a lower score indicates a lower level of anxiety.
The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in student satisfaction and self-confidence levels in learning.
Time frame: within one week of the simulation exercise
Student Satisfaction and Self-Confidence Scale in Learning: The sum of the scale's sub-dimensions does not yield the total scale score; scores are obtained by dividing the sum of the sub-dimension items by the number of items in the relevant sub-dimension. As the score obtained from the scale increases, students' satisfaction with learning and self-confidence also increase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 Group in people with Colostomy Stoma, run by Aybike Cici 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 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aybike Merve CİCİ (+905388759987, aybkmrv97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colostomy care training based on Jeffries' Simulation Theory provided to nursing students leads to changes in knowledge level scores. (time frame: within one week of the simulation exercise). The study lists 7 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 30 Apr 2026.