- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
23 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
44
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Şeyma Arslan
- Numer telefonu: +90 505 675 02 38
- E-mail: seyma.arsln1@gmail.com
Lokalizacje studiów
-
-
Üsküdar
-
Istanbul, Üsküdar, Turcja (Türkiye), 34668
- Rekrutacyjny
- Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
-
Kontakt:
- Şeyma Arslan, NURSE
- Numer telefonu: +90 505 675 02 38
- E-mail: seyma.arsln1@gmail.com
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka prawdopodobieństwa
Badana populacja
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
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
SELF-CARE POWER-SELF-CARE POWER SCALE SCORE
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
ANXIETY - STATE-TRAIT ANXIETY INVENTORY SCORE
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Şeyma Arslan, Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 września 2025
Zakończenie podstawowe (Szacowany)
1 września 2026
Ukończenie studiów (Szacowany)
1 września 2026
Daty rejestracji na studia
Pierwszy przesłany
10 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
26 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 25/424
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS
Typ informacji pomocniczych dotyczących udostępniania IPD
- ICF
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .