The Effect of Mandala on Anxiety and Fear Levels in Children With Leukemia Before Intrathecal Chemotherapy Treatment

NCT ID: NCT07203742

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2026-06-30

Brief Summary

This study aims to examine the effect of mandala coloring activity, administered before intrathecal chemotherapy treatment in children with leukemia, on pre-procedure anxiety and fear in children. The main question this study aims to answer is:

Does mandala coloring administered before intrathecal chemotherapy treatment reduce pre-procedure anxiety and fear in children with leukemia?

Descriptive demographic data will be collected from the children who will be given mandalas. Data will be collected using an Anxiety Scale and a Fear Scale.

Detailed Description

Acute leukemia, the most common cancer in childhood (32% in girls and boys aged 0-14), is characterized by the uncontrolled and abnormal proliferation of leukocytes in the bone marrow, where blood cells are produced. Chemotherapy agents are used in its treatment. Subsequently, intrathecal chemotherapy is administered according to the child's risk group and protocol. Intrathecal chemotherapy options include intrathecal methotrexate or a combination of intrathecal methotrexate with cytarabine and hydrocortisone. Numerous complications associated with chemotherapy may occur. These complications include fatigue, nausea and vomiting, hair loss, pancytopenia, mucositis, diarrhea, and constipation. In addition, psychological side effects such as depression, anxiety, fear, and insomnia are also frequently seen in children. Non-pharmacological methods are available for managing psychological side effects in individuals diagnosed with leukemia. These methods include psychoeducation, cognitive-behavioral therapy, art therapy, supportive psychotherapy, relaxation, and distraction techniques. In addition to these methods, mandala coloring, which can be used in many different situations, is also available. This study aims to investigate the effect of mandala coloring activity on anxiety and fear levels in children with leukemia before intrathecal treatment. The study will be conducted at the Pediatric Hematology Clinic of Ege University Faculty of Medicine Children's Hospital with a total of 60 children aged 4-12 years who are scheduled for intrathecal treatment. Children aged 4-12 years who meet the inclusion criteria and who will receive intrathecal chemotherapy due to leukemia treatment will be included in the study. The "Unmatched Control Group Model" will be used in the study, and randomization will not be performed. In this design, the intervention and control groups are planned to consist of participants with similar characteristics. To prevent/minimize interaction between groups, the control group data will be collected first. After the control group data is collected, the intervention group data will be collected. Data collection and the intervention will be carried out after the children are assigned to their groups. The SPSS 26.0 software package will be used to analyze the data obtained after the study. Frequency and percentage distributions will be used to check the distribution of participants' demographic characteristics and the normality of the data. Advanced analyses will then be performed.

Conditions

Acute Lymphoblastic Leukemia; Childhood Acute Leukemia; Acute Myeloblastic Leukaemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

mandala painting

Group Type: EXPERIMENTAL

mandala painting

Intervention Type: OTHER

After the child and parent agree to participate in the study and the child indicates that they wish to do the mandala exercise, the child will be seated in a comfortable position to paint. Thirty minutes before the start of the intrathecal chemotherapy procedure (children who will receive intrathecal chemotherapy at the clinic are identified and scheduled the day before), the child, their parent, and a nurse independent of the study will be assessed using the "Child Anxiety Scale-State (ÇAS-D)" and the "Child Fear Scale." The mandala coloring activity will then continue until the child wishes to stop (the activity will be ensured to last at least 30 minutes). When the child is called to the procedure room for intrathecal chemotherapy, the scale assessments will be repeated. Thirty minutes after the intrathecal chemotherapy procedure is completed and the child has emerged from the effects of general anesthesia, the scales will be reassessed and recorded by the same i

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mandala painting

After the child and parent agree to participate in the study and the child indicates that they wish to do the mandala exercise, the child will be seated in a comfortable position to paint. Thirty minutes before the start of the intrathecal chemotherapy procedure (children who will receive intrathecal chemotherapy at the clinic are identified and scheduled the day before), the child, their parent, and a nurse independent of the study will be assessed using the "Child Anxiety Scale-State (ÇAS-D)" and the "Child Fear Scale." The mandala coloring activity will then continue until the child wishes to stop (the activity will be ensured to last at least 30 minutes). When the child is called to the procedure room for intrathecal chemotherapy, the scale assessments will be repeated. Thirty minutes after the intrathecal chemotherapy procedure is completed and the child has emerged from the effects of general anesthesia, the scales will be reassessed and recorded by the same i

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The patient must be between 4 and 12 years of age.
• The patient must be hospitalized and followed up at the Pediatric Hematology Clinic.
• The patient must only be receiving leukemia treatment.
• The patient must not have any other chronic diseases.
• The patient must not have any systemic infections.
• The patient has received at least two courses of intrathecal chemotherapy treatment
• The patient does not have a diagnosis of psychological/mental symptoms as a side effect of chemotherapy treatment
• Intrathecal treatment will be administered to the patient in accordance with the chemotherapy protocol
• The patient and the caregiver parent are volunteers
• The caregiver parent speaks Turkish and is open to communication.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

SEDA ARDAHAN SEVGİLİ

Asst. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seda Ardahan Sevgili, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ege University

Central Contacts

Seda ARDAHAN SEVGİLİ, Ph.D

Role: CONTACT

sedardahan@gmail.com

00902323115572 ext. 5572

Other Identifiers

25-9.1T/59

Identifier Type: -

Identifier Source: org_study_id