Colostomy - StomaStomaNCT07464548
Effects of Stoma Education on Patients
A study testing Teach-Back Education in people with Colostomy - Stoma and Ileostomy - Stoma, run by Munzur University at 2 sites in Turkey (Türkiye).
Trial summary
tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colostomy - Stoma, Ileostomy - Stoma, Patient Education
- What is being tested?
- Teach-Back Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 10 Nov 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who have undergone colostomy or ileostomy surgery.
- Willingness to participate voluntarily in the study.
- Elective surgery patients.
- No diagnosed psychological disorders.
Who cannot join
- Emergency surgery cases.
- Patients with cognitive impairment or psychiatric disorders preventing participation.
- Patients unwilling to participate or unable to comply with study follow-ups.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Fırat University Hospital
Elâzığ
- Recruiting
Fırat University Hospital
Tunceli, City Center, 62000
Nilgün Söylemez, PhD, +905439790424, nilgunsoylemez@munzur.edu.tr
Beyzanur Kızıloğlu Ağgül, PhD
About this study
Official title: Determining the Effects of Stoma Education on Patients' Self-Efficacy, Body Image, and Stoma Adherence
tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma, Patient Education, Body Image, Self Efficacy, Adjustment
- Being tested
- Teach-Back Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-Back EducationOther
Stoma care training using the Teach-Back method.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | Teach-Back Education :Nursing intervention Intervention Type: Behavioral Intervention Name: Stoma Care Education Program "No drug or device is used in this intervention." Receives: Other: Teach-Back Education |
| Control Group | No intervention | Group receiving standard clinical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma Adjustment
Participant's adjustment to living with a stoma, assessed using a validated stoma adjustment scale at each follow-up. The Stoma Adjustment Scale is a psychosocial assessment tool developed to evaluate the extent to which individuals with stomas have adjusted to their new lives. The scale consists of numerous items that assess an individual's body image, social life, daily activities, ability to manage stoma care, and emotional adjustment, and is commonly used by stoma nurses and researchers. Items are scored using a Likert-type rating scale, and individuals are asked to indicate their level of agreement with each statement. Each item is generally scored from 1 to 6; a score of 1 indicates low adjustment, and a score of 6 indicates high adjustment. The scores of the items on the scale are added together to obtain a total adjustment score. A higher total score indicates better adjustment to the stoma and living with a stoma, while lower scores suggest that the individual may experience
Measured: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Secondary outcomes (2)
Body Image
Participant's perception and satisfaction with body image after stoma formation, measured using a standardized body image questionnaire. The Body Image Scale is a scale used to assess individuals' thoughts and feelings about their own body appearance. The scale consists of statements evaluating a person's level of satisfaction with their body, feelings of discomfort due to their appearance, self-confidence, and feelings about their body in social situations. The scale, comprising 10 items, is scored using a Likert-type scale, with each item rated between 0 and 3 (0: none, 1: somewhat, 2: quite, 3: very much). The scores obtained from the items are added together to obtain a total score between 0 and 30. A higher score indicates that the individual has more discomfort and negative perceptions regarding their body image; a lower score indicates a more positive body image.
Measured: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Self-Efficacy
Participant's confidence and ability to manage stoma care independently, assessed with a validated self-efficacy. The General Self-Efficacy Scale is a scale used to assess individuals' ability to cope with difficult situations and their belief in their ability to accomplish a specific task. The scale aims to measure an individual's problem-solving skills, willingness to overcome challenges, and self-confidence in achieving their goals. It is commonly used in health and psychology research to determine individuals' self-efficacy levels. The scale consists of 10 items and is scored using a Likert-type scale. Each item is rated on a scale of 1-4 (1: not at all correct, 2: somewhat correct, 3: fairly correct, 4: completely correct). The scores obtained from the items are added together to obtain a total score between 10-40. A high score indicates a high belief in self-efficacy and greater confidence in coping with challenges; a low score indicates a lower perception of self-efficacy.
Measured: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start10 Mar 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 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
- Model description
- This study is designed as a randomized, parallel-group interventional trial aiming to enroll at least 100 participants. Participants will be randomly assigned in a 1:1 ratio using Randomizer.org, with allocation concealment ensured through sealed opaque envelopes prepared by an independent researcher. Participants will be assigned to either the intervention group receiving structured stoma care education using the teach-back method or the control group receiving standard clinical education. Due to the nature of the educational intervention, blinding of participants and educators will not be feasible; however, outcome assessors and data analysts will be blinded to group allocation. The first assessment will be conducted on postoperative day 2, followed by evaluations at discharge, and at 1 and 3 months post-discharge. Outcome data will be collected at each time point to assess stoma care knowledge and patient adaptation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Munzur University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün SÖYLEMEZ, Munzur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464548
- Sponsor's protocol ID
- 2026\4-3-8294
- Acronym
- Stoma
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effects of Stoma Education on Patients' Self-Efficacy, Body Image, and Stoma Adherence
- ClinicalTrials.gov ID
- NCT07464548
- Acronym / sponsor ID
- Stoma / 2026\4-3-8294
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma, Patient Education, Body Image, Self Efficacy, Adjustment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Munzur UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 11 Mar 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.
tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomized, parallel-group interventional trial aiming to enroll at least 100 participants. Participants will be randomly assigned in a 1:1 ratio using Randomizer.org, with allocation concealment ensured through sealed opaque envelopes prepared by an independent researcher. Participants will be assigned to either the intervention group receiving structured stoma care education using the teach-back method or the control group receiving standard clinical education. Due to the nature of the educational intervention, blinding of participants and educators will not be feasible; however, outcome assessors and data analysts will be blinded to group allocation. The first assessment will be conducted on postoperative day 2, followed by evaluations at discharge, and at 1 and 3 months post-discharge. Outcome data will be collected at each time point to assess stoma care knowledge and patient adaptation.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Other: Teach-Back EducationTeach-Back Education :Nursing intervention Intervention Type: Behavioral Intervention Name: Stoma Care Education Program "No drug or device is used in this intervention." |
| Control Group | No intervention | –Group receiving standard clinical training |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults who have undergone colostomy or ileostomy surgery.
- Willingness to participate voluntarily in the study.
- Elective surgery patients.
- No diagnosed psychological disorders.
Key exclusion criteria (3 listed)
- Emergency surgery cases.
- Patients with cognitive impairment or psychiatric disorders preventing participation.
- Patients unwilling to participate or unable to comply with study follow-ups.
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 |
|---|---|---|
| Teach-Back EducationStoma care training using the Teach-Back method. | Other | Intervention Group |
Primary outcome
Stoma Adjustment
Time frame: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Participant's adjustment to living with a stoma, assessed using a validated stoma adjustment scale at each follow-up. The Stoma Adjustment Scale is a psychosocial assessment tool developed to evaluate the extent to which individuals with stomas have adjusted to their new lives. The scale consists of numerous items that assess an individual's body image, social life, daily activities, ability to manage stoma care, and emotional adjustment, and is commonly used by stoma nurses and researchers. Items are scored using a Likert-type rating scale, and individuals are asked to indicate their level of agreement with each statement. Each item is generally scored from 1 to 6; a score of 1 indicates low adjustment, and a score of 6 indicates high adjustment. The scores of the items on the scale are added together to obtain a total adjustment score. A higher total score indicates better adjustment to the stoma and living with a stoma, while lower scores suggest that the individual may experience
2 secondary outcomes
Body Image
Time frame: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Self-Efficacy
Time frame: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
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 13 Aug 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-Back Education in people with Colostomy - Stoma and Ileostomy - Stoma, run by Munzur 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 4 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
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 Nilgün Söylemez, PhD (+905439790424, nilgunsoylemez@munzur.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stoma Adjustment (time frame: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge). 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 13 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.