- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
44
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Şeyma Arslan
- Número de teléfono: +90 505 675 02 38
- Correo electrónico: seyma.arsln1@gmail.com
Ubicaciones de estudio
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Üsküdar
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Istanbul, Üsküdar, Turquía (Türkiye), 34668
- Reclutamiento
- Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
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Contacto:
- Şeyma Arslan, NURSE
- Número de teléfono: +90 505 675 02 38
- Correo electrónico: seyma.arsln1@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
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
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Ostomy Adjustment Score at 2 Months, as Measured by the Ostomy Adjustment Inventory-23 (OAI-23)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SELF-CARE POWER-SELF-CARE POWER SCALE SCORE
Periodo de tiempo: 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.
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From baseline to 2 months after the intervention
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ANXIETY - STATE-TRAIT ANXIETY INVENTORY SCORE
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Şeyma Arslan, Health Sciences University Sultan Abdulhamid II Han Training and Research Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2025
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
10 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de agosto de 2026
Publicado por primera vez (Actual)
26 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25/424
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
THE OSTOMY OPENED INDIVIDUALS' SELF-CARE POWER, OSTOMY ADJUSTMENT AND ANXIETY LEVELS
Tipo de información de apoyo para compartir IPD
- CIF
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .