- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07617766
Mindfulness Training in Type 2 Diabetes (MindfulT2DCA)
The Effect of Mindfulness-Based Self-Management Education on Diabetes-Related Difficulties and Empowerment in Individuals With Type 2 Diabetes
This study aims to evaluate the effects of mindfulness-based self-management education on diabetes-related difficulties and empowerment in individuals with type 2 diabetes. Participants will receive a structured education program designed to improve self-care behaviors, emotional well-being, and confidence in managing their condition.
The program includes mindfulness practices, diabetes self-management education, and supportive group sessions. Outcomes such as diabetes distress, self-management behaviors, and patient empowerment will be measured before and after the intervention.
The findings of this study are expected to contribute to improving patient-centered care and supporting individuals with type 2 diabetes in managing their health more effectively.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Type 2 diabetes is a chronic condition that requires continuous self-management, including medication adherence, lifestyle modification, and emotional coping. Many individuals experience diabetes-related difficulties, reduced motivation, and challenges in maintaining long-term self-care behaviors. Mindfulness-based approaches have been shown to improve emotional regulation, stress management, and self-efficacy in individuals with chronic illnesses.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based self-management education program in individuals with type 2 diabetes. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured program consisting of mindfulness practices, diabetes education, and group-based support sessions. The control group will receive usual care.
Primary outcomes include diabetes-related difficulties and patient empowerment. Secondary outcomes include self-care behaviors, emotional well-being, and perceived quality of life. Data will be collected at baseline and after completion of the intervention using validated assessment tools.
This study aims to provide evidence on whether integrating mindfulness into diabetes self-management education can improve both psychological and behavioral outcomes, thereby enhancing overall diabetes care and patient well-being.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Esmanur Günal, MSc
- Número de teléfono: +905537066125
- Correo electrónico: esmanurgunal2001@gmail.com
Ubicaciones de estudio
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Tortum
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Erzurum, Tortum, Turquía (Türkiye), 25430
- Tortum State Hospital
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Contacto:
- Esmanur Günal, MSc
- Número de teléfono: +905537066125
- Correo electrónico: esmanurgunal2001@gmail.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Aged between 18 and 65 years.
Diagnosed with Type 2 diabetes mellitus.
Literate (able to read and write).
Has access to and is able to actively use a smartphone or internet.
No diagnosed mental or cognitive impairment.
Willing to participate voluntarily and provide informed consent.
Exclusion Criteria:
- Previously received structured education related to their diabetes.
Pregnant.
Currently participating in another research study.
Hospitalized due to diabetes-related complications.
Unable to complete the education program.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mindfulness-Based Self-Management Education Group
Participants will receive a structured mindfulness-based self-management education program in addition to usual care.
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A structured education program including mindfulness practices, diabetes self-management education, and group-based support sessions
|
|
Comparador activo: Usual Care Control Group
Participants will receive standard diabetes care without additional intervention.
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Usual Care Control Group
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in self-management behavior score
Periodo de tiempo: Baseline to 8 weeks
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Measured using a validated self-management questionnaire
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Baseline to 8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Seda Başak, PhD, Atatürk University, Faculty of Nursing
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Aceptación del paciente de la atención médica
- Diabetes Mellitus, Tipo 2
- Participación del paciente
Otros números de identificación del estudio
- AtaturkUnurse
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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