Stoma ColostomyNCT06905925
The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy
A study testing The group receiving counseling in people with Stoma Colostomy and Colo-rectal Cancer, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The planned research aims to evaluate the impact of a training program on self-efficacy in patients with permanent colostomies. It highlights the importance of holistic patient education in preventing complications and improving adaptation to stomas, which can positively affect patients' quality of life and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stoma Colostomy, Colo-rectal Cancer
- What is being tested?
- The group receiving counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2025to 1 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients scheduled for permanent colostomy following colorectal surgery,
- Aged 18 years and older,
- Conscious, with orientation to person, time, and place,
- Able to speak Turkish,
- Without auditory or visual impairments,
- Using a phone, were included in the study. Exclusion Criteria:• Patients who could not be contacted during the study period, or those who developed post-operative complications (such as stenosis, necrosis, ileus, dermatitis, parastomal herniation, etc.) were excluded from the sample.
Who cannot join
None listed.
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
Adana City Training and Research Hospital
Adana, Yüreğir, 01220
Cansel Bozer, Expert, +905434332624, cansel9815@gmail.com
Ceylan Kişial, expert, +905068010561, cylnksl@gmail.com
About this study
The planned research aims to evaluate the impact of a training program on self-efficacy in patients with permanent colostomies. It highlights the importance of holistic patient education in preventing complications and improving adaptation to stomas, which can positively affect patients' quality of life and self-efficacy.
Read the detailed description
Stomas can be either temporary or permanent. Stomas can cause physical issues such as uncontrolled gas output, bad odor, leakage, and local skin irritation, as well as psychological and social problems such as sexual dysfunction, changes in body image, decreased self-esteem, interpersonal relationship issues, depression, anxiety, loneliness, fear, and shame. These problems can reduce individuals' self-care abilities, negatively affect daily living activities, increase their vulnerability to stoma/peristomal complications, and further delay the closure of temporary stomas. Regardless of the type of stoma, all of these issues negatively impact patients' self-efficacy.
Many of these problems and potential complications after stoma formation are preventable. Patient education provided through a holistic approach covering pre-operative, post-operative, and home care and follow-up is of great importance in preventing complications and improving patients' adaptation to the stoma. However, a review of the literature reveals that stoma-related education programs typically focus on assessing quality of life and similar factors. Some of the studies reviewed include educational content on pre-operative patient preparation and post-operative care, while others focus only on post-operative complication management. However, high-evidence guidelines, such as Enhanced Recovery After Surgery (ERAS) protocols, emphasize that the first step toward a successful surgical process should be patient education delivered through a holistic approach covering the entire surgical process.
Therefore, the planned research will be conducted to evaluate the effect of a training program provided to patients with permanent colostomies on self-efficacy.
- Conditions
- Stoma Colostomy, Colo-rectal Cancer
- Being tested
- The group receiving counseling
- Keywords
- stoma, Colo-rectal cancer, consulting, self-efficacy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group receiving counselingOther
Patients in the experimental group will receive pre-operative stoma care education from the researcher. This training is expected to last approximately 15 minutes. After the training, a brochure will be provided to the patients, which they can use if they need additional information. During the training process, patients will be informed that the researcher will contact them by phone during the 1st, 2nd, 3rd, and 4th weeks after discharge. During these calls, patients will be asked weekly (during weeks 1, 2, 3, and 4) about the color, odor, texture of the wound area, the function of the colostomy, and any complications. Additionally, at the end of the 2nd week, if there are no issues around the wound or sutures, patients will be called to the hospital for suture removal and dressing changes. In other weeks, dietary habits and the condition of the wound will also be inquired. During this four-week period, patients or their relatives will be informed that they can contact the researcher
| Study group | Role | What they receive |
|---|---|---|
| no intervention group | No intervention | No intervention will be performed by the researcher for the patients in the control group. During this process, standard care education will be provided by clinical nurses, and phone follow-up and counseling protocols will not be applied. Patients in the control group will also be contacted by phone by the researcher during the 2nd and 4th weeks after discharge to complete the "Stoma Self-Efficacy Scale (S-SES)." |
| intervention group | Experimental | Here is the English translation of the provided text:
Patients in the experimental group will receive pre-operative stoma care education from the researcher. This training is expected to last approximately 15 minutes. After the training, a brochure will be provided to the patients, which they can use if they need additional information. During the training process, patients will be informed that the researcher will contact them by phone during the 1st, 2nd, 3rd, and 4th weeks after discharge. During these calls, patients will be asked weekly (during weeks 1, 2, 3, and 4) about the color, odor, texture of the wound area, the function of the colostomy, and any complications. Additionally, at the end of the 2nd week, if there are no issues around the wound or sutures, patients will be called to the hospital for suture removal and dressing changes. In other weeks, dietary habits and the condition of the wound will also be inquired. During this four-week period, patients or their relativ Receives: Other: The group receiving counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma Self-Efficacy Scale (S-SES)
The scale was developed to examine the self-efficacy status of patients with stoma. Its validity and reliability in Turkish were conducted by Karaçay et al. The scale consists of 22 items and two subscales. The scale is a 5-point Kickert type, rated from 1 to 5, where 1: definitely do not trust and 5: definitely trust. Items 1-13 of the scale examine Stoma Care Self-Efficacy (S-SES Care), and items 14-22 examine Social Life Self-Efficacy (S-SES Social). The lowest score that can be obtained from the scale is 22, while the highest score is 110. A higher score indicates higher self-efficacy. In the Turkish validity-reliability study of the scale, the Croncbach alpha coefficient was found to be 0.95
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start23 Jun 2025
- Primary completion30 Jun 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma ColostomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To eliminate selection bias and ensure balance in the number of patients between groups, randomization will be performed in the study. Randomization will be generated by an independent researcher not involved in the study using a computer tool (https://www.randomizer.org/), and X envelopes will be numbered from 1 to X. Inside the envelopes, cards will indicate whether the participant belongs to the intervention or control group based on the randomization table. Participants who are admitted to the clinic and consent to participate in the study by signing the consent form will be assigned to the intervention or control group based on the envelope number corresponding to their admission order. Once the researcher obtains written consent from the participants, they will open the envelope to determine which group the participant belongs to. This process ensures that randomization and group assignment are concealed, thus controlling for selection bias in the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansel Bozer, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905925
- Sponsor's protocol ID
- CU-SBF-CB-03
- Status last verified
- Sep 2025
- First submitted
- 8 Dec 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't want to for personal reasons.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy
- ClinicalTrials.gov ID
- NCT06905925
- Acronym / sponsor ID
- CU-SBF-CB-03
- Conditions
- Stoma Colostomy, Colo-rectal Cancer
- Keywords
- stoma, Colo-rectal cancer, consulting, self-efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Apr 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 planned research aims to evaluate the impact of a training program on self-efficacy in patients with permanent colostomies. It highlights the importance of holistic patient education in preventing complications and improving adaptation to stomas, which can positively affect patients' quality of life and self-efficacy.
Detailed description
Stomas can be either temporary or permanent. Stomas can cause physical issues such as uncontrolled gas output, bad odor, leakage, and local skin irritation, as well as psychological and social problems such as sexual dysfunction, changes in body image, decreased self-esteem, interpersonal relationship issues, depression, anxiety, loneliness, fear, and shame. These problems can reduce individuals' self-care abilities, negatively affect daily living activities, increase their vulnerability to stoma/peristomal complications, and further delay the closure of temporary stomas. Regardless of the type of stoma, all of these issues negatively impact patients' self-efficacy.
Many of these problems and potential complications after stoma formation are preventable. Patient education provided through a holistic approach covering pre-operative, post-operative, and home care and follow-up is of great importance in preventing complications and improving patients' adaptation to the stoma. However, a review of the literature reveals that stoma-related education programs typically focus on assessing quality of life and similar factors. Some of the studies reviewed include educational content on pre-operative patient preparation and post-operative care, while others focus only on post-operative complication management. However, high-evidence guidelines, such as Enhanced Recovery After Surgery (ERAS) protocols, emphasize that the first step toward a successful surgical process should be patient education delivered through a holistic approach covering the entire surgical process.
Therefore, the planned research will be conducted to evaluate the effect of a training program provided to patients with permanent colostomies on self-efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- To eliminate selection bias and ensure balance in the number of patients between groups, randomization will be performed in the study. Randomization will be generated by an independent researcher not involved in the study using a computer tool (https://www.randomizer.org/), and X envelopes will be numbered from 1 to X. Inside the envelopes, cards will indicate whether the participant belongs to the intervention or control group based on the randomization table. Participants who are admitted to the clinic and consent to participate in the study by signing the consent form will be assigned to the intervention or control group based on the envelope number corresponding to their admission order. Once the researcher obtains written consent from the participants, they will open the envelope to determine which group the participant belongs to. This process ensures that randomization and group assignment are concealed, thus controlling for selection bias in the study.
| Arm | Type | Receives |
|---|---|---|
| no intervention group | No intervention | –No intervention will be performed by the researcher for the patients in the control group. During this process, standard care education will be provided by clinical nurses, and phone follow-up and counseling protocols will not be applied. Patients in the control group will also be contacted by phone by the researcher during the 2nd and 4th weeks after discharge to complete the "Stoma Self-Efficacy Scale (S-SES)." |
| intervention group | Experimental | Other: The group receiving counselingHere is the English translation of the provided text: Patients in the experimental group will receive pre-operative stoma care education from the researcher. This training is expected to last approximately 15 minutes. After the training, a brochure will be provided to the patients, which they can use if they need additional information. During the training process, patients will be informed that the researcher will contact them by phone during the 1st, 2nd, 3rd, and 4th weeks after discharge. During these calls, patients will be asked weekly (during weeks 1, 2, 3, and 4) about the color, odor, texture of the wound area, the function of the colostomy, and any complications. Additionally, at the end of the 2nd week, if there are no issues around the wound or sutures, patients will be called to the hospital for suture removal and dressing changes. In other weeks, dietary habits and the condition of the wound will also be inquired. During this four-week period, patients or their relativ |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Patients scheduled for permanent colostomy following colorectal surgery,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The group receiving counselingPatients in the experimental group will receive pre-operative stoma care education from the researcher. This training is expected to last approximately 15 minutes. After the training, a brochure will be provided to the patients, which they can use if they need additional information. During the training process, patients will be informed that the researcher will contact them by phone during the 1st, 2nd, 3rd, and 4th weeks after discharge. During these calls, patients will be asked weekly (during weeks 1, 2, 3, and 4) about the color, odor, texture of the wound area, the function of the colostomy, and any complications. Additionally, at the end of the 2nd week, if there are no issues around the wound or sutures, patients will be called to the hospital for suture removal and dressing changes. In other weeks, dietary habits and the condition of the wound will also be inquired. During this four-week period, patients or their relatives will be informed that they can contact the researcher | Other | intervention group |
Primary outcome
Stoma Self-Efficacy Scale (S-SES)
Time frame: 1 years
The scale was developed to examine the self-efficacy status of patients with stoma. Its validity and reliability in Turkish were conducted by Karaçay et al. The scale consists of 22 items and two subscales. The scale is a 5-point Kickert type, rated from 1 to 5, where 1: definitely do not trust and 5: definitely trust. Items 1-13 of the scale examine Stoma Care Self-Efficacy (S-SES Care), and items 14-22 examine Social Life Self-Efficacy (S-SES Social). The lowest score that can be obtained from the scale is 22, while the highest score is 110. A higher score indicates higher self-efficacy. In the Turkish validity-reliability study of the scale, the Croncbach alpha coefficient was found to be 0.95
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 12 Sep 2025.
- Individual participant dataSharing planned: No. I don't want to for personal reasons.
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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 The group receiving counseling in people with Stoma Colostomy and Colo-rectal Cancer, run by Cukurova 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 6 inclusion and 0 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 12 Sep 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?
Contact Cansel Bozer, expert (+905434332624, cansel9815@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stoma Self-Efficacy Scale (S-SES) (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.