- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07788079
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
August 23, 2026 updated by: Saglik Bilimleri Universitesi
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Şeyma Arslan
- Phone Number: +90 505 675 02 38
- Email: seyma.arsln1@gmail.com
Study Locations
-
-
Üsküdar
-
Istanbul, Üsküdar, Turkey (Türkiye), 34668
- Recruiting
- Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
-
Contact:
- Şeyma Arslan, NURSE
- Phone Number: +90 505 675 02 38
- Email: seyma.arsln1@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having a poor general health condition
- Having a neurological disorder
- Having a psychiatric disorder
- Providing incomplete responses to the study scales
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Providing Ostomy Education to Individuals Who Have Undergone Ostomy Surgery Using the "Teach-Back" Method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 2 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SELF-CARE POWER-SELF-CARE POWER SCALE SCORE
Time Frame: From baseline to 2 months after the intervention
|
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.
|
From baseline to 2 months after the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ANXIETY - STATE-TRAIT ANXIETY INVENTORY SCORE
Time Frame: From baseline to 2 months after the intervention
|
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI).
The STAI consists of 40 items, including 20 items assessing state anxiety and 20 items assessing trait anxiety.
Each item is rated on a 4-point scale.
Scores for each subscale range from 20 to 80, with higher scores indicating higher anxiety levels.
The change in anxiety scores from baseline to 2 months after the intervention will be evaluate
|
From baseline to 2 months after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Şeyma Arslan, Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
August 10, 2026
First Submitted That Met QC Criteria
August 23, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 23, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25/424
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS
IPD Sharing Supporting Information Type
- ICF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.