- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07702682
Visual Art Therapy on Caregiver Burden (Visual art)
The Effect of Visual Art Therapy Applied to Family Caregivers of Patients Hospitalized in a Palliative Care Unit on Caregiver Burden, Caregiving Stress, and Burnout: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Background: Zentangle is a visual art therapy method that can be used for meditative purposes by promoting creativity and focused attention in individuals under stress, thereby indirectly facilitating mental relaxation, stress relief, and mindfulness.
Aim: This study aimed to determine the effect of Zentangle practice on perceived caregiver burden, stress levels, and burnout among family caregivers of patients receiving palliative care.
Design: This study was designed as a randomized controlled experimental trial with a pretest-posttest design and was conducted between March and June 2025.
Setting/Participants: The study sample consisted of 60 family caregivers of patients hospitalized in a palliative care unit, including 30 participants in the intervention group and 30 in the control group.
Intervention: Participants in the intervention group received a two-week meditative art therapy intervention based on the Zentangle method. The control group followed the standard routine care process without the art therapy intervention.
Data Collection: Data were collected through face-to-face interviews. The data collection tools included an Individual Descriptive Information Form, the Caregiver Burden Scale, the Caregiver Stress Index, and the Maslach Burnout Inventory-General Survey. These tools were administered to both groups as pretest measures before the intervention and as posttest measures immediately following the completion of the two-week study period.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Elâzığ
-
Elâzığ, Elâzığ, Turquía (Türkiye), 23100
- Fırat University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Being a family caregiver of a patient hospitalized in the palliative care unit
Volunteering to participate in the study
Being aged 18 years or older
Being able to communicate in the local language
Providing care for the patient for at least one month
Exclusion Criteria:
Having a previously diagnosed major psychiatric illness or cognitive impairment that prevents participation in art therapy
Having visual or physical impairments that interfere with performing fine motor tasks required for the Zentangle method
Participating in any other concurrent psychological or art therapy intervention during the study period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention group
Caregivers in this group will receive Zentangle training in addition to standard hospital routines.
The program aims to provide informative instruction on the method and support caregivers.
|
The fact that this type of sampling has never been applied before.
|
|
Sin intervención: Control group
Caregivers in this group will follow the standard hospital routine and receive regular follow-ups without any additional intervention, education, or specific training program during the study period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Caregiver Burden Scale
Periodo de tiempo: 2 months
|
Outcome Measure Title: Change from baseline in Caregiver Burden Scale scores at 2 weeks. Description: Caregiver burden is assessed using the Caregiver Burden Scale. The scale evaluates the physical, emotional, and social burden experienced by caregivers. Total scores range from 0 to 88, with higher scores indicating a higher perceived caregiver burden. |
2 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Caregiver Stress Index
Periodo de tiempo: 2 months
|
Outcome Measure Title: Change from baseline in Caregiver Stress Index scores at 2 weeks. Description: Caregiver stress levels are assessed using the Caregiver Stress Index. This tool evaluates the stress related to caregiving activities. Total scores range from 0 to 13, with higher scores indicating a higher level of caregiver stress. |
2 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 3171272024-184
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.
producto fabricado y exportado desde los EE. UU.
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. .