Mandala coloring to reduce anxiety and fear in children with leukemia before intrathecal chemotherapy
The Effect of Mandala on Anxiety and Fear Levels in Children With Leukemia Before Intrathecal Chemotherapy Treatment
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Ege University Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (Izmir) |
| Trial ID | NCT07203742 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Izmir
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.