Clinical trial Recruiting at 1 site Interventional Ages 4 to 12

Mandala coloring to reduce anxiety and fear in children with leukemia before intrathecal chemotherapy

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

Run by Ege University · NCT07203742 · Data updated 2026-11-12

This will try mandala coloring with children aged 4–12 who have leukemia to see if it lowers their anxiety and fear before intrathecal chemotherapy.

More Acute Lymphoblastic Leukemia trials

Quick facts

Study typeInterventional
Ages4 Years to 12 Years
SexAll
Enrollment60 (estimated)
SponsorEge University
Academic / other
Drugs / interventionschemotherapy, methotrexate
Locations1 site (Izmir)
StatusRecruiting
StartedSeptember 29, 2025
Main results expectedAugust 2026
Study endsSeptember 2026
Registry record updatedFebruary 17, 2026
Trial IDNCT07203742 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 4–12 with leukemia who are hospitalized and receiving intrathecal chemotherapy at the Pediatric Hematology Clinic and whose caregiver is a Turkish-speaking volunteer meet the typical inclusion criteria.

Probably not a fit

Children outside the 4–12 age range, those with other chronic illnesses or systemic infections, those with documented chemotherapy-related psychiatric diagnoses, or children unable to engage with coloring activities may not receive benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children with leukemia hospitalized at Ege University will complete a mandala coloring activity immediately before their scheduled intrathecal chemotherapy, and demographic information will be recorded. Anxiety and fear will be measured using validated anxiety and fear scales before and after the intervention. The intervention is non-pharmacological and delivered in the Pediatric Hematology Clinic setting by nursing staff. Results will compare pre-procedure anxiety and fear levels to determine the effect of the mandala activity.

Why it matters

Potential benefit: If successful, mandala coloring could lower pre-procedure anxiety and fear in children undergoing intrathecal chemotherapy, improving comfort and cooperation during the procedure.

How similar studies have gone: Prior small studies of art therapy and distraction techniques have shown modest reductions in procedure-related anxiety, and mandala coloring has shown promising but limited evidence in pediatric and adult settings.

Who can join: the full rules

Show full inclusion / exclusion 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.

Exclusion Criteria:

* Cases that do not meet the inclusion criteria will be excluded from the study.

Where it's running

  • Ege University Childrens Hospital
    Izmir, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: Seda Ardahan Sevgili, Ph.D. — Ege University
  • Study coordinator: Seda ARDAHAN SEVGİLİ, Ph.D
  • Email: sedardahan@gmail.com
  • Phone: 00902323115572

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.