Effect of Mandala Coloring on Nausea, Fatigue, and Well-Being in Chemotherapy Patients (MANDALACHEMO)
The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This study is a clinical trial designed to investigate the effects of mandala coloring on nausea, vomiting, fatigue, and psychological well-being in cancer patients receiving chemotherapy. Chemotherapy is commonly associated with both physical and psychological side effects that negatively impact patients' quality of life.
The intervention consists of structured mandala coloring sessions conducted during chemotherapy cycles. Participants will perform the coloring activity in a calm and appropriate clinical environment. No pharmacological or additional psychological interventions will be applied during the study period.
Outcome measures include the severity of nausea, vomiting, and fatigue, as well as psychological well-being levels, assessed using validated scales at baseline and after the intervention. Differences in these outcomes will be analyzed to evaluate the effectiveness of the mandala coloring intervention.
The study is expected to provide evidence regarding low-cost, non-pharmacological supportive care methods that may improve symptom management and psychological health in chemotherapy patients.
10000 chars
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turquía (Türkiye), 27000
- Gaziantep University Vocational School of Health Services
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients diagnosed with cancer Patients receiving chemotherapy treatment Age 18 years and older Patients who are able to communicate verbally Patients who agree to participate in the study and sign informed consent form Patients without cognitive impairment
Exclusion Criteria:
- Patients with severe psychiatric disorders Patients with visual or cognitive impairments preventing participation in mandala coloring Patients in critical clinical condition or intensive care unit Patients who refuse to continue participation Patients receiving additional concurrent psychological interventions
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: The effect of mandala practice on nausea, vomiting, and fatigue
Cancer patients receiving chemotherapy in this group participated in a structured mandala painting intervention in addition to standard care.
The intervention was applied during chemotherapy infusion and continued within the first 24 hours after treatment.
Patients engaged in individual coloring activities using standardized mandala templates in a calm environment aimed at promoting relaxation and reducing symptom burden.
|
Participants in the intervention group performed a structured mandala coloring activity designed to promote relaxation and reduce chemotherapy-related symptoms.
Pre-designed mandala patterns and colored pencils were provided.
The session was conducted in a quiet environment and lasted approximately 20-30 minutes.
The intervention was applied once.
Outcomes including nausea, vomiting, fatigue, and psychological well-being were assessed within 24 hours after the intervention.
|
|
Sin intervención: Control: Standard Care
Patients in this group received standard chemotherapy care only without any additional non-pharmacological intervention.
Outcomes such as nausea, vomiting, fatigue, and psychological well-being were assessed for comparison with the experimental group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Effect of Mandala Coloring on Nausea, Vomiting, Fatigue, and Psychological Well-Being in Cancer Patients Receiving Chemotherapy
Periodo de tiempo: Within 24 hours after the intervention
|
Nausea and vomiting severity were assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
Fatigue levels were measured using a standardized fatigue scale, and psychological well-being was assessed using a validated psychological well-being scale.
Outcome measures were compared between the mandala painting group and the control group before and within 24 hours after the intervention.
|
Within 24 hours after the intervention
|
|
The effects of mandala painting on nausea, vomiting, fatigue, and psychological well-being in cancer patients undergoing chemotherapy.
Periodo de tiempo: 24 hours after intervention
|
Fatigue Severity Questionnaire: The fatigue severity scale is a unidimensional questionnaire with a total score of 16 on a seven-point Likert scale, and higher total scores indicate greater fatigue. Psychological Well-being Scale: The scale consists of 8 items and is a 7-point Likert type. The scale is single-dimensional, with a minimum score of 8 and a maximum score of 56. Higher scores on the scale indicate higher overall psychological well-being. |
24 hours after intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adile Neşe, University of Gaziantep
Publicaciones y enlaces útiles
Publicaciones Generales
- Yuruk E, Todil T, Askan F, Kara M, Hacisalihoglu A. Effects of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children and youth receiving outpatient chemotherapy. J Pediatr Nurs. 2026 Jan-Feb;86:366-374. doi: 10.1016/j.pedn.2025.11.029. Epub 2025 Nov 26.
- Dadashi N, Khanali Mojen L, Ilkhani M, Nasirie M, Mirzaee HR, Boozaripour M. Effect of Mandala Art Therapy on Quality of Life in Breast Cancer Patients. Asian Pac J Cancer Prev. 2025 Jul 1;26(7):2533-2540. doi: 10.31557/APJCP.2025.26.7.2533.
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
- Mandala Coloring Chemotherapy
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
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. .