Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508632
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
The Effect of Mandala on Nausea Vomiting Pain and Anxiety in Chemotherapy Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Mandala Art Therapy Coloring on Nausea Vomiting Pain and Anxiety in Children Receiving Outpatient Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the effect of mandala art therapy coloring on nausea vomiting pain and anxiety in children receiving outpatient chemotherapy The concept of cancer is used to describe a group of diseases that start from a single cell and show uncontrolled growth proliferation and spread to surrounding tissues The cooperation of the family and the healthcare team plays a major role in the success of the treatment Surgical treatment radiotherapy and chemotherapy are applied in its treatment Art therapy a method of distraction is used to prevent pediatric oncology patients from focusing on the pain and stressful life events they experience By having children do artistic activities in the hospital room nurses can reduce symptom management social isolation and long-term negative social effects
Detailed Description:
Cancer treatment in children is determined according to the type of cancer its stage and the childs general health condition Treatment options include the following chemotherapy radiotherapy surgery immunotherapy and targeted therapy The following problems are observed in children receiving chemotherapy in the short and long term fever fatigue weight loss pain fatigue anxiety nausea and vomiting changes in sleep and mood 91 of oncology patients have benefited from Complementary and Alternative Medicine CAM such as art to improve their general health and painting painting music and dance and mind-body therapies have been shown to have positive effects on the quality of life in pediatric oncology patients
Art therapy in the pediatric oncology patient population The American Art Therapy Association AATA 2013 defines art therapy as healing Increasing the physical mental and emotional well-being of individuals is considered as creative interventions of art production These interventions have been widely used as alternative treatments for a variety of conditions including cancer
Although there is a significant amount of research on the effects of art therapies there is a lack of research in the existing literature regarding their specific effects on symptoms such as nausea vomiting pain and anxiety However the effects on quality of life are generally given more attention
Among the art therapies Mandala art therapy is a type of art therapy using circular patterns and symbols In this therapy participants explore their inner world and express their emotions by creating their own mandates It gives individuals the opportunity to concretize the complex and abstract thoughts in their minds caused by their painful experiences Emotions and thoughts are spontaneously embedded in artistic products such as sculpture music painting marbling and mandala Mandala therapy improves creativity and problem-solving skills by increasing emotional awareness and expression
As a result mandala art therapy can be used in the treatment of many different problems such as stress anxiety depression trauma and chronic disease as well as in the management of symptoms
To determine the sample size of the study the power of the study was calculated with the G-Power 3192 program using the confidence interval and effect size parameters 80 power 95 confidence interval and effect size of 05 or more In the G-Power 3192 program the total sample size was calculated as 48 2424 based on 005 significance 080 large effect and 80 power However considering the 10 loss and taking into account the parametric test assumption the sample number of each group was determined as 30 people in the intervention group and 30 people in the control group for a total of 60 people
Art therapy in the pediatric oncology patient population The American Art Therapy Association AATA 2013 defines art therapy as healing Increasing the physical mental and emotional well-being of individuals is considered as creative interventions of art production These interventions have been widely used as alternative treatments for a variety of conditions including cancer
Although there is a significant amount of research on the effects of art therapies there is a lack of research in the existing literature regarding their specific effects on symptoms such as nausea vomiting pain and anxiety However the effects on quality of life are generally given more attention
Among the art therapies Mandala art therapy is a type of art therapy using circular patterns and symbols In this therapy participants explore their inner world and express their emotions by creating their own mandates It gives individuals the opportunity to concretize the complex and abstract thoughts in their minds caused by their painful experiences Emotions and thoughts are spontaneously embedded in artistic products such as sculpture music painting marbling and mandala Mandala therapy improves creativity and problem-solving skills by increasing emotional awareness and expression
As a result mandala art therapy can be used in the treatment of many different problems such as stress anxiety depression trauma and chronic disease as well as in the management of symptoms
To determine the sample size of the study the power of the study was calculated with the G-Power 3192 program using the confidence interval and effect size parameters 80 power 95 confidence interval and effect size of 05 or more In the G-Power 3192 program the total sample size was calculated as 48 2424 based on 005 significance 080 large effect and 80 power However considering the 10 loss and taking into account the parametric test assumption the sample number of each group was determined as 30 people in the intervention group and 30 people in the control group for a total of 60 people
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None