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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).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • 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

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07788079
Study groupRoleWhat they receive
Who Have Undergone Ostomy SurgeryOSTOMY 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.

  1. 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)
  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.

  1. First posted26 Aug 2026
  2. Study start1 Sep 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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)
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

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.

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