- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
44
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Şeyma Arslan
- Numéro de téléphone: +90 505 675 02 38
- E-mail: seyma.arsln1@gmail.com
Lieux d'étude
-
-
Üsküdar
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Istanbul, Üsküdar, Turquie (Türkiye), 34668
- Recrutement
- Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
-
Contact:
- Şeyma Arslan, NURSE
- Numéro de téléphone: +90 505 675 02 38
- E-mail: seyma.arsln1@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SELF-CARE POWER-SELF-CARE POWER SCALE SCORE
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
ANXIETY - STATE-TRAIT ANXIETY INVENTORY SCORE
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Şeyma Arslan, Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2025
Achèvement primaire (Estimé)
1 septembre 2026
Achèvement de l'étude (Estimé)
1 septembre 2026
Dates d'inscription aux études
Première soumission
10 août 2026
Première soumission répondant aux critères de contrôle qualité
23 août 2026
Première publication (Réel)
26 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 25/424
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS
Type d'informations de prise en charge du partage d'IPD
- CIF
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .