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

NCT07203742 | Recruiting DMC

• 1 other identifier: 25-9.1T/59
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia; Childhood Acute Leukemia; Acute Myeloblastic Leukaemia

Keywords

intrathechal chemotherapy treatment; anxiety; fear; mandala; nursing

Outcome Measures

Primary Outcomes (2)

• Fear of intrathecal chemotherapy

  The fear that children will experience due to intrathecal chemotherapy will be collected using the "Children's Fear Scale".

  From enrollment to 30 minutes after intrathecal chemotherapy

• Anxiety of intrathecal chemotherapy

  The fear that children will experience due to intrathecal chemotherapy will be collected using the "Children's Anxiety Scale".

  From enrollment to 30 minutes after intrathecal chemotherapy

Study Arms (2)

mandala painting

EXPERIMENTAL

Other: mandala painting

control

NO INTERVENTION

Interventions

mandala painting 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

mandala painting

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Childrens Hospital

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Anxiety Disorders

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Mental Disorders

Study Officials

• Seda Ardahan Sevgili, Ph.D.

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seda ARDAHAN SEVGİLİ, Ph.D

CONTACT

00902323115572; sedardahan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 2, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)