Stoma ColostomyNCT06391398
The Impact of Education Using a Stoma Care Training Belt
A study testing Stoma care education with the Stoma Care Training Belt in people with Stoma Colostomy and Stoma Ileostomy, run by Ankara University at 2 sites in Turkey (Türkiye).
Trial summary
Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- Stoma care education with the Stoma Care Training Belt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2024to 22 Apr 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
- Intestinal stoma (colostomy or ileostomy) opened for the first time,
- Those aged 18 and over, Able to speak and understand Turkish,
- Conscious, oriented and cooperative,
- Does not have a diagnosed psychiatric or psychological disease,
- There is no obstacle to stoma care, Those who have no previous stoma knowledge or training.
Who cannot join
- Those who do not agree to participate in the study,
- Refuses to perform stoma care in the postoperative period,
- Leaving the job voluntarily, Those who died during the work process,
- Referred from the relevant hospital during the treatment process,
- Any postoperative complications (bleeding, infection, fistula, etc.) develop,
- Data collection forms could not be completed,
- Patients who cannot be reached will be excluded.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hatice ÖNER CENGİZ
Altındağ, Ankara, 06080
Ankara University
Ankara, Ankara, 06080
About this study
Official title: The Impact of Education Using a Stoma Care Training Belt on Care Skills, Adaptation, Anxiety, and Patient Satisfaction in Patients Undergoing Intestinal Stoma Creation:Randomized Controlled Trial
Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Patient education on stoma care during the preoperative period may facilitate stoma adaptation. The aim of this study is to evaluate the impact of the education provided to patients undergoing intestinal stoma creation using a Stoma Care Training Belt on stoma care skills, adaptation, anxiety, and satisfaction.
Read the detailed description
Introduction:Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Patient education on stoma care during the preoperative period may facilitate stoma adaptation. The aim of this study is to evaluate the impact of the education provided to patients undergoing intestinal stoma creation using a Stoma Care Training Belt on stoma care skills, adaptation, anxiety, and satisfaction. This study will be conducted as a parallel group, randomized controlled study at Ankara University Health Practice and Research Hospitals Ibn-i Sina Research and Practice Hospital and Ankara University Health Practice and Research Hospitals Cebeci Research and Practice Hospital General Surgery Clinics.The analysis was performed in G*Power version 3.1.9.4.It was planned to include a total of 170 patients in the study, 85 patients in each group.In order to ensure similarity between groups; Simple randomization will be used to assign the women in the sample group to the experimental and control groups. Data, sociodemographic and medical data form, State Anxiety Scale, Stoma Care Skill Rubric, Ostomy Adaptation Scale-23 and Visual Analogue Scale (VAS)-Patient satisfaction level will be collected.Patients will be evaluated 5 times in total: on the day of discharge, and on the 5th, 15th and 30th days after discharge. The data will be evaluated in a computer environment with appropriate statistical methods using the Statistical Package for Social Sciences 25 (SPSS) for Windows statistical package program.Ethics committee permission was received for the research from Ankara University Ethics Committee. Permission was obtained from the institution where the research would be conducted.This research is supported by the Scientific and Technological Research Council of Turkey (TUBITAK).
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Being tested
- Stoma care education with the Stoma Care Training Belt
- Keywords
- Ostomy, Education of patients, Anxiety, Patient Satisfaction
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma care education with the Stoma Care Training BeltBehavioural
Stoma care education
| Study group | Role | What they receive |
|---|---|---|
| Stoma care belt group | Experimental | In addition to routine treatment and care, patients in the intervention stoma care belt group will receive education with the Stoma Care Training Belt during the preoperative period. Receives: Behavioral: Stoma care education with the Stoma Care Training Belt |
| Control group | No intervention | Patients in the control group will not undergo any additional intervention beyond routine treatment and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma Care Skills
Stoma Care Skill will be evaluated 4 times in total, using the Stoma Care Skill Rubric, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. It consists of 23 items that include stoma care process steps. For each process step, the learner's competence is scored between 0-2 (0- Insufficient, 1- Partially adequate, 2- Satisfactory). A minimum of 0 and a maximum of 46 points can be obtained from the key. The total score obtained from the key indicates the adequacy of stoma care skills.
Measured: day of discharge and on days 5th, 15th and 30th after discharge
Stoma compliance
Patients' stoma compliance levels will be evaluated 4 times in total, using the Ostomy Compliance Scale-23, on the day of discharge and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The scale score varies between 0-92 points. Higher scores from each scale item indicate increased compliance.
Measured: day of discharge and on days 5th, 15th and 30th after discharge
Anxiety
The anxiety levels of the patients will be evaluated 5 times in total, using the State Anxiety Scale, on the day before surgery, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control.The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Measured: the day before surgery, day of discharge and on days 5th, 15th and 30th after discharge
Secondary outcomes (1)
Patient Satisfaction
Visual Analog Scale will be used to evaluate patients' satisfaction levels with the training provided with the Stoma Care Training Belt. Accordingly, they will be asked to give a score between 0 (very dissatisfied) and 10 (highest possible satisfaction) regarding their level of satisfaction with the training provided with the Stoma Care Training Belt. As the score increases, the satisfaction level increases.
Measured: the day before surgery, day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2024
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Model description
- parallel-group, randomized controlled trial will be conducted to assess the effect of the Stoma Care Training Belt on patients' stoma care skills, adaptation, anxiety, and satisfaction. A total of 170 patients, with 85 in the intervention group and 85 in the control group, will be included. All patients in the study will receive routine stoma care education as part of their standard treatment and care. In addition to routine treatment and care, patients in the intervention group will receive education with the Stoma Care Training Belt during the preoperative period.
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice ÖNER CENGİZ, Ankara University
- Investigators
- Mehmet YÜKSEKKAYA, PhD, Study chair, Ankara Universityİlknur Münevver GÖNENÇ, PhD, Study chair, Ankara UniversityAyten DEMİR, PhD, Study chair, Ankara UniversityAyhan Bülent ERKEK, MD, Study chair, Ankara UniversityŞiyar ERSÖZ, MD, Study chair, Ankara UniversitySerpil UÇAR, MSc, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391398
- Sponsor's protocol ID
- HOCengiz
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers do not intend to share research data. But the researchers may only share data from participants for meta-analysis study of randomized controlled trials.
Publications
Oner Cengiz H, Yuksekkaya M, Gonenc IM, Ucar S, Demir A, Ersoz S, Erkek AB, Sen E. Effect of a Stoma Care Training Belt on Stoma Care Skills, Adjustment, Anxiety and Satisfaction in Intestinal Stoma Patients: Randomized Controlled Study. Nurs Open. 2026 Jul;13(7):e70713. doi: 10.1002/nop2.70713.
PubMed 42499259
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Education Using a Stoma Care Training Belt on Care Skills, Adaptation, Anxiety, and Patient Satisfaction in Patients Undergoing Intestinal Stoma Creation:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06391398
- Acronym / sponsor ID
- HOCengiz
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Keywords
- Ostomy, Education of patients, Anxiety, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 30 Apr 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.
Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Patient education on stoma care during the preoperative period may facilitate stoma adaptation. The aim of this study is to evaluate the impact of the education provided to patients undergoing intestinal stoma creation using a Stoma Care Training Belt on stoma care skills, adaptation, anxiety, and satisfaction.
Detailed description
Introduction:Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Patient education on stoma care during the preoperative period may facilitate stoma adaptation. The aim of this study is to evaluate the impact of the education provided to patients undergoing intestinal stoma creation using a Stoma Care Training Belt on stoma care skills, adaptation, anxiety, and satisfaction. This study will be conducted as a parallel group, randomized controlled study at Ankara University Health Practice and Research Hospitals Ibn-i Sina Research and Practice Hospital and Ankara University Health Practice and Research Hospitals Cebeci Research and Practice Hospital General Surgery Clinics.The analysis was performed in G*Power version 3.1.9.4.It was planned to include a total of 170 patients in the study, 85 patients in each group.In order to ensure similarity between groups; Simple randomization will be used to assign the women in the sample group to the experimental and control groups. Data, sociodemographic and medical data form, State Anxiety Scale, Stoma Care Skill Rubric, Ostomy Adaptation Scale-23 and Visual Analogue Scale (VAS)-Patient satisfaction level will be collected.Patients will be evaluated 5 times in total: on the day of discharge, and on the 5th, 15th and 30th days after discharge. The data will be evaluated in a computer environment with appropriate statistical methods using the Statistical Package for Social Sciences 25 (SPSS) for Windows statistical package program.Ethics committee permission was received for the research from Ankara University Ethics Committee. Permission was obtained from the institution where the research would be conducted.This research is supported by the Scientific and Technological Research Council of Turkey (TUBITAK).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel-group, randomized controlled trial will be conducted to assess the effect of the Stoma Care Training Belt on patients' stoma care skills, adaptation, anxiety, and satisfaction. A total of 170 patients, with 85 in the intervention group and 85 in the control group, will be included. All patients in the study will receive routine stoma care education as part of their standard treatment and care. In addition to routine treatment and care, patients in the intervention group will receive education with the Stoma Care Training Belt during the preoperative period.
| Arm | Type | Receives |
|---|---|---|
| Stoma care belt group | Experimental | Behavioral: Stoma care education with the Stoma Care Training BeltIn addition to routine treatment and care, patients in the intervention stoma care belt group will receive education with the Stoma Care Training Belt during the preoperative period. |
| Control group | No intervention | –Patients in the control group will not undergo any additional intervention beyond routine treatment and care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intestinal stoma (colostomy or ileostomy) opened for the first time,
- Those aged 18 and over, Able to speak and understand Turkish,
- Conscious, oriented and cooperative,
- Does not have a diagnosed psychiatric or psychological disease,
- There is no obstacle to stoma care, Those who have no previous stoma knowledge or training.
Key exclusion criteria (7 listed)
- Those who do not agree to participate in the study,
- Refuses to perform stoma care in the postoperative period,
- Leaving the job voluntarily, Those who died during the work process,
- Referred from the relevant hospital during the treatment process,
- Any postoperative complications (bleeding, infection, fistula, etc.) develop,
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 |
|---|---|---|
| Stoma care education with the Stoma Care Training BeltStoma care education | Behavioural | Stoma care belt group |
Primary outcome
Stoma Care Skills
Time frame: day of discharge and on days 5th, 15th and 30th after discharge
Stoma Care Skill will be evaluated 4 times in total, using the Stoma Care Skill Rubric, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. It consists of 23 items that include stoma care process steps. For each process step, the learner's competence is scored between 0-2 (0- Insufficient, 1- Partially adequate, 2- Satisfactory). A minimum of 0 and a maximum of 46 points can be obtained from the key. The total score obtained from the key indicates the adequacy of stoma care skills.
Stoma compliance
Time frame: day of discharge and on days 5th, 15th and 30th after discharge
Patients' stoma compliance levels will be evaluated 4 times in total, using the Ostomy Compliance Scale-23, on the day of discharge and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The scale score varies between 0-92 points. Higher scores from each scale item indicate increased compliance.
Anxiety
Time frame: the day before surgery, day of discharge and on days 5th, 15th and 30th after discharge
The anxiety levels of the patients will be evaluated 5 times in total, using the State Anxiety Scale, on the day before surgery, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control.The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
1 secondary outcome
Patient Satisfaction
Time frame: the day before surgery, day of discharge
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 4 May 2025.
- Derived from this study: PubMed 42499259Oner Cengiz H, Yuksekkaya M, Gonenc IM, Ucar S, Demir A, Ersoz S, Erkek AB, Sen E. Effect of a Stoma Care Training Belt on Stoma Care Skills, Adjustment, Anxiety and Satisfaction in Intestinal Stoma Patients: Randomized Controlled Study. Nurs Open. 2026 Jul;13(7):e70713. doi: 10.1002/nop2.70713.
- Individual participant dataSharing planned: No. The researchers do not intend to share research data. But the researchers may only share data from participants for meta-analysis study of randomized controlled trials.
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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.
Mehmet YÜKSEKKAYA, PhD study chair
Ankara University
İlknur Münevver GÖNENÇ, PhD study chair
Ankara University
Ayten DEMİR, PhD study chair
Ankara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoma care education with the Stoma Care Training Belt in people with Stoma Colostomy and Stoma Ileostomy, run by Ankara University 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 7 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 4 May 2025. 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?
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 Skills (time frame: day of discharge and on days 5th, 15th and 30th after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06391398, which also lists 1 linked publication.
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 4 May 2025.