- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
44
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Şeyma Arslan
- Telefonnummer: +90 505 675 02 38
- E-post: seyma.arsln1@gmail.com
Studieorter
-
-
Üsküdar
-
Istanbul, Üsküdar, Turkiet (Türkiye), 34668
- Rekrytering
- Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
-
Kontakt:
- Şeyma Arslan, NURSE
- Telefonnummer: +90 505 675 02 38
- E-post: seyma.arsln1@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
SELF-CARE POWER-SELF-CARE POWER SCALE SCORE
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
ANXIETY - STATE-TRAIT ANXIETY INVENTORY SCORE
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Şeyma Arslan, Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2025
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
1 september 2026
Studieregistreringsdatum
Först inskickad
10 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
23 augusti 2026
Första postat (Faktisk)
26 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25/424
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS
IPD-delning som stöder informationstyp
- ICF
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .