Ileostomy - StomaNCT06979102
The Effect of Real Patient Interactive Stoma Care Management Teaching
A study testing Real Patient Interactive Stoma Care Management Teaching and Standard Stoma Care Management Teaching in people with Ileostomy - Stoma and Caregiver, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Colorectal cancer is a type of cancer that is on the rise worldwide. Ileostomy with surgical treatment is one of the common treatment methods for this cancer. Regardless of whether the ileostomy is temporary or permanent, both patients with ileostomy and their caregivers are negatively affected physically and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma, Caregiver, Care Management
- What is being tested?
- Real Patient Interactive Stoma Care Management Teaching and Standard Stoma Care Management Teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2025to 12 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
- For newly ileostomy patients;
- 18 years of age and over,
- Speak, read, write, and understand Turkish,
- Not having received teaching on stoma care and management before,
- No previous experience in stoma care and management. For caregivers;
- 18 years of age and over,
Show all 10Show fewer
- Speak, read, write, and understand Turkish,
- Being an informal (unpaid) caregiver of a newly ileostomised patient,
- Not having received teaching on stoma care and management before,
- No previous experience in stoma care and management.
Who cannot join
- For newly ileostomy patients; - Not participating in stoma care management teaching and follow-ups after ileostomy opening.
- For caregivers;
- Not participating in stoma care management teaching and follow-ups after ileostomy opening.
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
Ankara Provincial Directorate of Health University of Health Sciences Gülhane Training and Research Hospital
Ankara, Turkey, 06010
About this study
Official title: The Effect of Real Patient Interactive Stoma Care Management Teaching on Care Participation and Care Management Process of Ileostomy Patient and Caregiver: A Randomized Controlled Trial
Colorectal cancer is a type of cancer that is on the rise worldwide. Ileostomy with surgical treatment is one of the common treatment methods for this cancer. Regardless of whether the ileostomy is temporary or permanent, both patients with ileostomy and their caregivers are negatively affected physically and psychologically during this process. Patients with an ileostomy are especially at risk for ileostomy-related complications and metabolic complications. Stoma care management training on ileostomy care is critical in preventing these negativities. In this context, as a result of a real patient with ileostomy who has experience in opening an ileostomy and adapting to life with ileostomy, receiving structured training on stoma care teachings, the real patient with an ileostomy will take part in interactive stoma care management teachings in which the newly ileostomy patient and caregiver will take part together with a stoma and wound care nurses, and the processes of participation in care and care management of the newly ileostomy patient and caregiver will be improved, it is predicted that complications, physical and psychological problems that may develop related to ileostomy will be limited and contribute to public health in the long term. This research aims to determine the effect of real patient interactive stoma care management teaching on the processes of participation in care and care management of the newly ileostomy patient and caregiver. In this research, a randomized controlled full experimental research design with a post-test control group will be used. The population of the study will consist of newly ileostomy patients and their caregivers at Ankara Provincial Directorate of Health University of Health Sciences Gulhane Training and Research Hospital General Surgery Clinic. The sample of the study will be determined by using the criterion sampling method, one of the purposive sampling methods. Newly ileostomy patients and their caregivers who are eligible for the inclusion-exclusion criteria and who volunteer to participate in the study will be included. The research's data will be obtained using the Patient's Descriptive Characteristics Form, Caregiver's Descriptive Characteristics Form, Ostomy Self-Care Index, Caregiver Contribution to Self-Care in Ostomy Patient Index, Patient Health Engagement Scale, and Caregiver Health Engagement Scale. The implementation of the research will be carried out in two stages. In the first stage, real patients with an ileostomy will be identified, and training will be given to real patients on real patient interactive stoma care management with an ileostomy. In this context, to determine the expectations of individuals with stomas and their caregivers regarding stoma care management teaching, the plan was to determine the experiences of individuals with a prior permanent or temporary ileostomy/colostomy and current stomas and their caregivers regarding stoma care management education at the institution where the study was conducted. This plan was to structure the training to be delivered as part of the first stage of the study. To this end, ethics committee approval and institutional permission were obtained for the study titled "Determining the Stoma Care Education Experiences of Individuals with Stomas and Their Caregivers: A Qualitative Study." The opinions of individuals with stomas and their caregivers were collected, and the training was organized accordingly as part of the first stage of the study. In the second stage, real patient with ileostomy interactive stoma care management teaching will be applied to newly ileostomy patients and their caregivers in the intervention group, while standard stoma care management teaching will be applied to newly ileostomy patients and their caregivers in the control group. The objectives of this research are as follows: preparation of real patients with ileostomy; completion of real patients with ileostomy interactive stoma care management teaching with the intervention group; completion of standard stoma care management teaching with the control group; data analysis and statistical evaluations. It is predicted that with the real patient with ileostomy interactive stoma care management teaching, improvement will be achieved in the processes of participation in care and care management of the newly ileostomy patient and caregiver, complications, physical and psychological problems that may develop related to ileostomy will be limited, and in the long term, public health will be contributed.
- Conditions
- Ileostomy - Stoma, Caregiver, Care Management, Care Participation, Real Patient Interaction
- Being tested
- Real Patient Interactive Stoma Care Management Teaching, Standard Stoma Care Management Teaching
- Keywords
- Caregiver, Ileostomy patient, Care management, Care participation, Real patient interaction, Teaching intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Patient Interactive Stoma Care Management TeachingOther
The real patient interactive stoma care management teaching will be carried out with ileostomy patients who have recently undergone ileostomy surgery and their caregivers in the intervention group. The 2nd month after discharge, the newly ileostomy patients and their caregivers will be asked one open-ended question to elicit their thoughts and suggestions regarding the real patient interactive stoma care management teaching. The question is: "A real patient with a previous ileostomy participated in the stoma care management teaching. He demonstrated how to perform ileostomy care on himself and shared his experiences and suggestions regarding adapting to life with an ileostomy. What are your thoughts and suggestions regarding this teaching?"
Standard Stoma Care Management TeachingOther
The standard stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The real patient interactive stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the intervention group. Receives: Other: Real Patient Interactive Stoma Care Management Teaching |
| Control Group | Active comparator | The standard stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the control group. Receives: Other: Standard Stoma Care Management Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the processes of participation in care of the newly ileostomy patient with the Ostomy Self-Care Index
The scale has a 5-point Likert structure. The scale score is determined by adding the scores obtained from each item in the scale. As the scale score increases, the level of self-care management of the ostomy patient increases.
Measured: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
To determine the processes of participation in care of the caregiver with the Caregiver Contribution to Self-Care in Ostomy Patient Index
The scale has a 5-point Likert structure. The scale score is determined by adding the scores obtained from each item in the scale. As the scale score increases, the caregiver's support for the stoma-related self-care of the patient with an ostomy increases.
Measured: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
To determine the processes of care management of the caregiver with the Caregiving Health Engagement Scale
The scale has a total of 6 items and each item includes 4 statements and 7 options (A, B, C, D, E, F and G); options A and B are in the denial phase and have a score of 1, options C and D are in the hyperactivation phase and have a score of 2, options E and F are in the drowning phase and have a score of 3, option G is in the balance phase and has a score of 4; the scores of the caregiver for each item are ranked and the median value of the scores shows the participation phase in which the caregiver is located.
Measured: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
To determine the processes of care management of the newly ileostomy patient with the Patient Health Engagement Scale
The scale has a total of 5 items and each item contains 4 statements and 7 options (A, B, C, D, E, F and G); A and B options are in the blackout phase and have a score of 1, C and D options are in the arousal phase and have a score of 2, E and F options are in the adhesion phase and have a score of 3, G option is in the eudaimonic project and has a score of 4; the scores the patient receives for each item are listed and the median value of the scores shows the participation phase the patient is in.
Measured: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start13 Apr 2025
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Caz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979102
- Sponsor's protocol ID
- 2024/10-28
- Other IDs
- 424S083
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Real Patient Interactive Stoma Care Management Teaching on Care Participation and Care Management Process of Ileostomy Patient and Caregiver: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06979102
- Acronym / sponsor ID
- 2024/10-28
- Conditions
- Ileostomy - Stoma, Caregiver, Care Management, Care Participation, Real Patient Interaction
- Keywords
- Caregiver, Ileostomy patient, Care management, Care participation, Real patient interaction, Teaching intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 13 Apr 2025 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 18 May 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.
Colorectal cancer is a type of cancer that is on the rise worldwide. Ileostomy with surgical treatment is one of the common treatment methods for this cancer. Regardless of whether the ileostomy is temporary or permanent, both patients with ileostomy and their caregivers are negatively affected physically and psychologically during this process. Patients with an ileostomy are especially at risk for ileostomy-related complications and metabolic complications. Stoma care management training on ileostomy care is critical in preventing these negativities. In this context, as a result of a real patient with ileostomy who has experience in opening an ileostomy and adapting to life with ileostomy, receiving structured training on stoma care teachings, the real patient with an ileostomy will take part in interactive stoma care management teachings in which the newly ileostomy patient and caregiver will take part together with a stoma and wound care nurses, and the processes of participation in care and care management of the newly ileostomy patient and caregiver will be improved, it is predicted that complications, physical and psychological problems that may develop related to ileostomy will be limited and contribute to public health in the long term. This research aims to determine the effect of real patient interactive stoma care management teaching on the processes of participation in care and care management of the newly ileostomy patient and caregiver. In this research, a randomized controlled full experimental research design with a post-test control group will be used. The population of the study will consist of newly ileostomy patients and their caregivers at Ankara Provincial Directorate of Health University of Health Sciences Gulhane Training and Research Hospital General Surgery Clinic. The sample of the study will be determined by using the criterion sampling method, one of the purposive sampling methods. Newly ileostomy patients and their caregivers who are eligible for the inclusion-exclusion criteria and who volunteer to participate in the study will be included. The research's data will be obtained using the Patient's Descriptive Characteristics Form, Caregiver's Descriptive Characteristics Form, Ostomy Self-Care Index, Caregiver Contribution to Self-Care in Ostomy Patient Index, Patient Health Engagement Scale, and Caregiver Health Engagement Scale. The implementation of the research will be carried out in two stages. In the first stage, real patients with an ileostomy will be identified, and training will be given to real patients on real patient interactive stoma care management with an ileostomy. In this context, to determine the expectations of individuals with stomas and their caregivers regarding stoma care management teaching, the plan was to determine the experiences of individuals with a prior permanent or temporary ileostomy/colostomy and current stomas and their caregivers regarding stoma care management education at the institution where the study was conducted. This plan was to structure the training to be delivered as part of the first stage of the study. To this end, ethics committee approval and institutional permission were obtained for the study titled "Determining the Stoma Care Education Experiences of Individuals with Stomas and Their Caregivers: A Qualitative Study." The opinions of individuals with stomas and their caregivers were collected, and the training was organized accordingly as part of the first stage of the study. In the second stage, real patient with ileostomy interactive stoma care management teaching will be applied to newly ileostomy patients and their caregivers in the intervention group, while standard stoma care management teaching will be applied to newly ileostomy patients and their caregivers in the control group. The objectives of this research are as follows: preparation of real patients with ileostomy; completion of real patients with ileostomy interactive stoma care management teaching with the intervention group; completion of standard stoma care management teaching with the control group; data analysis and statistical evaluations. It is predicted that with the real patient with ileostomy interactive stoma care management teaching, improvement will be achieved in the processes of participation in care and care management of the newly ileostomy patient and caregiver, complications, physical and psychological problems that may develop related to ileostomy will be limited, and in the long term, public health will be contributed.
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 |
|---|---|---|
| Intervention Group | Experimental | Other: Real Patient Interactive Stoma Care Management TeachingThe real patient interactive stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the intervention group. |
| Control Group | Active comparator | Other: Standard Stoma Care Management TeachingThe standard stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For newly ileostomy patients;
- 18 years of age and over,
- Speak, read, write, and understand Turkish,
- Not having received teaching on stoma care and management before,
- No previous experience in stoma care and management. For caregivers;
Key exclusion criteria (3 listed)
- For newly ileostomy patients; - Not participating in stoma care management teaching and follow-ups after ileostomy opening.
- For caregivers;
- Not participating in stoma care management teaching and follow-ups after ileostomy opening.
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 |
|---|---|---|
| Real Patient Interactive Stoma Care Management TeachingThe real patient interactive stoma care management teaching will be carried out with ileostomy patients who have recently undergone ileostomy surgery and their caregivers in the intervention group. The 2nd month after discharge, the newly ileostomy patients and their caregivers will be asked one open-ended question to elicit their thoughts and suggestions regarding the real patient interactive stoma care management teaching. The question is: "A real patient with a previous ileostomy participated in the stoma care management teaching. He demonstrated how to perform ileostomy care on himself and shared his experiences and suggestions regarding adapting to life with an ileostomy. What are your thoughts and suggestions regarding this teaching?" | Other | Intervention Group |
| Standard Stoma Care Management TeachingThe standard stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the control group. | Other | Control Group |
Primary outcome
To determine the processes of participation in care of the newly ileostomy patient with the Ostomy Self-Care Index
Time frame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
The scale has a 5-point Likert structure. The scale score is determined by adding the scores obtained from each item in the scale. As the scale score increases, the level of self-care management of the ostomy patient increases.
To determine the processes of participation in care of the caregiver with the Caregiver Contribution to Self-Care in Ostomy Patient Index
Time frame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
The scale has a 5-point Likert structure. The scale score is determined by adding the scores obtained from each item in the scale. As the scale score increases, the caregiver's support for the stoma-related self-care of the patient with an ostomy increases.
To determine the processes of care management of the caregiver with the Caregiving Health Engagement Scale
Time frame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
The scale has a total of 6 items and each item includes 4 statements and 7 options (A, B, C, D, E, F and G); options A and B are in the denial phase and have a score of 1, options C and D are in the hyperactivation phase and have a score of 2, options E and F are in the drowning phase and have a score of 3, option G is in the balance phase and has a score of 4; the scores of the caregiver for each item are ranked and the median value of the scores shows the participation phase in which the caregiver is located.
To determine the processes of care management of the newly ileostomy patient with the Patient Health Engagement Scale
Time frame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
The scale has a total of 5 items and each item contains 4 statements and 7 options (A, B, C, D, E, F and G); A and B options are in the blackout phase and have a score of 1, C and D options are in the arousal phase and have a score of 2, E and F options are in the adhesion phase and have a score of 3, G option is in the eudaimonic project and has a score of 4; the scores the patient receives for each item are listed and the median value of the scores shows the participation phase the patient is in.
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 31 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Patient Interactive Stoma Care Management Teaching and Standard Stoma Care Management Teaching in people with Ileostomy - Stoma and Caregiver, run by Hacettepe 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 10 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: enrolling by invitation, as of the sponsor's last update on 31 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?
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?
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?
To determine the processes of participation in care of the newly ileostomy patient with the Ostomy Self-Care Index (time frame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.). The study lists 4 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 31 Jul 2025.