The Effect of Mandala on Nausea, Vomiting, Pain and Anxiety in Chemotherapy Patients

NCT06508632 | Completed

• 1 other identifier: F ASKAN
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Mandala Art Therapy; Child; Nausea Vomiting; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain Rating scale

  It is a visual analog scale used to evaluate the intensity of pain. This scale includes six different facial expressions scored from 0 to 10. 0 means "no pain," while 10 means "most severe pain." The scale is used to diagnose pain in children aged 3-18. Pain scores are given according to the numerical values given to the faces on the scale. The lowest score is "1" and the highest score is "5". As the score from the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases.

  Approximately 2 hours from start

Secondary Outcomes (1)

• Nausea and Vomiting Thermometer in Children with Cancer

  Approximately 2 hours from start

Study Arms (2)

Experimantal group

EXPERIMENTAL

Individual mandala activity will be carried out in all sample groups after admission to the clinic where they come to receive outpatient chemotherapy and when they start taking medication.

Behavioral: Mandala group

Control Group

NO INTERVENTION

In this study, the control group will receive standard care.

Interventions

Mandala group BEHAVIORAL

Individual mandala activity will be carried out in all sample groups after admission to the clinic where they come to receive outpatient chemotherapy and when they start taking medication. Children will color (paint).

Also known as: Control group

Experimantal group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being at the pediatric chemotherapy clinic to receive outpatient chemotherapy
• Receiving daily chemotherapy
• Those who agreed to participate in the research
• Mother and child must know Turkish
• The child knows colors

You may not qualify if:

• Having a mental health problem (preventing the use of Mandala therapy coloring technique)
• Having a disability that prevents you from seeing or using your hand (a condition that prevents you from using the Mandala therapy coloring technique)

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova University Balcalı Training and Research Hospital

Adana, Balçalı, 01250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Experimental, randomised controlled, single-blind study

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 18, 2024
• Study Start: April 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

TU (1)