Ostomy - Ileostomy or ColostomyNCT07788079
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
An observational study of Ostomy - Ileostomy or Colostomy and Canser, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of ostomy care education-delivered to patients who have undergone ostomy surgery using the Teach-back method on patients' self-care ability, ostomy compliance, and anxiety levels. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Ostomy - Ileostomy or Colostomy, Canser, Ileus
- What is being tested?
- TEACH BACK METHOD
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to Sep 2026
- Phase
- Observational
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-84 with ostomies who are hospitalized in the General Surgery Clinic at Sultan Abdulhamid II Han Training and Research Hospital, Health Sciences University
Who may be able to join
- Having an ostomy
- Being between 18 and 84 years of age
- Speaking Turkish
- Being literate
- Voluntarily participating in the study
- Having no hearing, visual, or mental disabilities
- Being well-oriented to person, place, and time
Who cannot join
- Having a poor general health condition
- Having a neurological disorder
- Having a psychiatric disorder
- Providing incomplete responses to the study scales
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
Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
Istanbul, Üsküdar, 34668
Şeyma Arslan, NURSE, +90 505 675 02 38, seyma.arsln1@gmail.com
About this study
The aim of this study is to examine the effect of ostomy care education-delivered to patients who have undergone ostomy surgery using the Teach-back method on patients' self-care ability, ostomy compliance, and anxiety levels.
Read the detailed description
An ostomy is a surgical procedure performed to allow waste products to be expelled from the body through a different route. This procedure, which can be either permanent or temporary, is typically performed in cases such as colorectal cancer, inflammatory bowel diseases, or bladder cancer. The number of patients with ostomies is increasing day by day, both worldwide and in our country. Because an ostomy leads to significant changes in a person's life, patient education is of critical importance for patients who have undergone ostomy surgery. Education aims to help patients understand changes in their health status, improve their adherence to treatment, and enhance their quality of life. Among modern educational methods, approaches such as mobile apps, virtual reality, and the "Teach-back" method are gaining prominence. The "Teach-back" method is based on having patients express what they have learned in their own words and is an effective learning strategy. It involves a questioning process to determine what the individual has understood from the interaction. If the instructor believes that the learner has not understood the topic or has understood it incompletely, the training process is repeated. The process is completed when the learner understands the topic and provides the correct answer. Self-care is conceptualized as a series of activities that individuals undertake to maintain, improve, or enhance their overall health. Individuals need motivation, experiential knowledge, and skills to engage in the behaviors necessary to maintain and improve their health and quality of life, and all of these are fundamentally based on the principle of self-care. There are many positive outcomes to using education to provide higher-quality care to patients. Patients with ostomies may struggle to accept their ostomy and their new way of life, as well as to adapt to this situation, due to changes in their physical appearance and psychosocial challenges. Through education and counseling, nurses can help patients become better informed and manage their ostomy care independently, thereby improving their ability to adapt. The most common causes of anxiety are a lack of information and fear of the unknown. In individuals who have undergone ostomy surgery, it has been observed that anxiety levels decrease when this uncertainty is addressed through education. Developing self-care skills in individuals with ostomies and supporting their physical and psychosocial adjustment are among the core care functions of nurses. It is expected that providing education will reduce patients' anxiety levels while improving their ostomy adjustment and self-care abilities. The literature contains a limited number of research findings on the effects of education provided using the "Tell Me What You've Learned" method in different patient groups. However, no studies have been found specifically examining the effects of education provided using this method in patients with ostomies. It is believed that studies on the effects of education provided using the "Tell Me What You Learned" method in patients who have undergone ostomy surgery will make significant contributions to the literature.
- Conditions
- Ostomy - Ileostomy or Colostomy, Canser, Ileus, Intestinal Cancer
- Being tested
- TEACH BACK METHOD
- Keywords
- ostomy, self care power, ostomy adjustment, nursing, Teach-back method, patient education
- Medical subject headings
- Ileus, Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACH BACK METHODBehavioural
Providing Ostomy Education to Individuals Who Have Undergone Ostomy Surgery Using the "Teach-Back" Method
| Study group | Role | What they receive |
|---|---|---|
| Who Have Undergone Ostomy Surgery | OSTOMY CARE EDUCATION APPLIED WİTH TEACH-BACK METHOD TO OSTOMY OPENED INDIVIDUALS ON SELF-CARE POWER OSTOMY ADJUSTMENT AND ANXIETY Receives: Behavioral: TEACH BACK METHOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23)
Ostomy adjustment will be assessed using the Ostomy Adjustment Inventory-23 (OAI-23), a 23-item self-report scale. Each item is scored on a 5-point Likert scale from 0 to 4, with a total score ranging from 0 to 92. Higher scores indicate better adjustment to living with an ostomy. The outcome will be the change in the total OAI-23 score from baseline to 2 months after the intervention.
Measured: Baseline and 2 months after the intervention
Secondary outcomes (1)
SELF-CARE POWER-SELF-CARE POWER SCALE SCORE
Self-care power will be assessed using the Self-Care Power Scale. The scale consists of 35 items, each rated on a 5-point Likert scale from 0 to 4, with a total score ranging from 0 to 140. Higher scores indicate greater self-care power. The change in the total scale score from baseline to 2 months will be evaluated.
Measured: From baseline to 2 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostomy - Ileostomy or ColostomyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Şeyma Arslan, Principal investigator, Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788079
- Sponsor's protocol ID
- 25/424
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Individual data sharing
- Yes: THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
- ClinicalTrials.gov ID
- NCT07788079
- Acronym / sponsor ID
- 25/424
- Conditions
- Ostomy - Ileostomy or Colostomy, Canser, Ileus, Intestinal Cancer
- Keywords
- ostomy, self care power, ostomy adjustment, nursing, Teach-back method, patient education
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effect of ostomy care education-delivered to patients who have undergone ostomy surgery using the Teach-back method on patients' self-care ability, ostomy compliance, and anxiety levels.
Detailed description
An ostomy is a surgical procedure performed to allow waste products to be expelled from the body through a different route. This procedure, which can be either permanent or temporary, is typically performed in cases such as colorectal cancer, inflammatory bowel diseases, or bladder cancer. The number of patients with ostomies is increasing day by day, both worldwide and in our country. Because an ostomy leads to significant changes in a person's life, patient education is of critical importance for patients who have undergone ostomy surgery. Education aims to help patients understand changes in their health status, improve their adherence to treatment, and enhance their quality of life. Among modern educational methods, approaches such as mobile apps, virtual reality, and the "Teach-back" method are gaining prominence. The "Teach-back" method is based on having patients express what they have learned in their own words and is an effective learning strategy. It involves a questioning process to determine what the individual has understood from the interaction. If the instructor believes that the learner has not understood the topic or has understood it incompletely, the training process is repeated. The process is completed when the learner understands the topic and provides the correct answer. Self-care is conceptualized as a series of activities that individuals undertake to maintain, improve, or enhance their overall health. Individuals need motivation, experiential knowledge, and skills to engage in the behaviors necessary to maintain and improve their health and quality of life, and all of these are fundamentally based on the principle of self-care. There are many positive outcomes to using education to provide higher-quality care to patients. Patients with ostomies may struggle to accept their ostomy and their new way of life, as well as to adapt to this situation, due to changes in their physical appearance and psychosocial challenges. Through education and counseling, nurses can help patients become better informed and manage their ostomy care independently, thereby improving their ability to adapt. The most common causes of anxiety are a lack of information and fear of the unknown. In individuals who have undergone ostomy surgery, it has been observed that anxiety levels decrease when this uncertainty is addressed through education. Developing self-care skills in individuals with ostomies and supporting their physical and psychosocial adjustment are among the core care functions of nurses. It is expected that providing education will reduce patients' anxiety levels while improving their ostomy adjustment and self-care abilities. The literature contains a limited number of research findings on the effects of education provided using the "Tell Me What You've Learned" method in different patient groups. However, no studies have been found specifically examining the effects of education provided using this method in patients with ostomies. It is believed that studies on the effects of education provided using the "Tell Me What You Learned" method in patients who have undergone ostomy surgery will make significant contributions to the literature.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Who Have Undergone Ostomy Surgery | – | Behavioral: TEACH BACK METHODOSTOMY CARE EDUCATION APPLIED WİTH TEACH-BACK METHOD TO OSTOMY OPENED INDIVIDUALS ON SELF-CARE POWER OSTOMY ADJUSTMENT AND ANXIETY |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-84 with ostomies who are hospitalized in the General Surgery Clinic at Sultan Abdulhamid II Han Training and Research Hospital, Health Sciences University
Key inclusion criteria (7 listed)
- Having an ostomy
- Being between 18 and 84 years of age
- Speaking Turkish
- Being literate
- Voluntarily participating in the study
Key exclusion criteria (4 listed)
- Having a poor general health condition
- Having a neurological disorder
- Having a psychiatric disorder
- Providing incomplete responses to the study scales
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 METHODProviding Ostomy Education to Individuals Who Have Undergone Ostomy Surgery Using the "Teach-Back" Method | Behavioural | Who Have Undergone Ostomy Surgery |
Primary outcome
Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23)
Time frame: Baseline and 2 months after the intervention
Ostomy adjustment will be assessed using the Ostomy Adjustment Inventory-23 (OAI-23), a 23-item self-report scale. Each item is scored on a 5-point Likert scale from 0 to 4, with a total score ranging from 0 to 92. Higher scores indicate better adjustment to living with an ostomy. The outcome will be the change in the total OAI-23 score from baseline to 2 months after the intervention.
1 secondary outcome
SELF-CARE POWER-SELF-CARE POWER SCALE SCORE
Time frame: From baseline to 2 months after the intervention
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS
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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.
Şeyma Arslan principal investigator
Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy - Ileostomy or Colostomy and Canser, run by Saglik Bilimleri Universitesi 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 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 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 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 Şeyma Arslan (+90 505 675 02 38, seyma.arsln1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23) (time frame: Baseline and 2 months after the intervention). 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 26 Aug 2026.