The Effect of Mandala on Anxiety and Fear Levels in Children With Leukemia Before Intrathecal Chemotherapy Treatment
- Sponsor
- Ege University
- Study ID
- NCT07203742
- Status
- Recruiting
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloblastic Leukaemia
- Childhood Acute Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - 12 Years
- Healthy Volunteers
- Not accepted
Interventions
- mandala painting — OTHERAfter 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
Study Details
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.
Key Dates
- First listed
- Oct 2, 2025
- Start date
- Sep 29, 2025
- Status verified
- Feb 2026
- Primary completion
- Aug 31, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: mandala painting
- No Intervention: control
Primary Outcome Measure
Fear of intrathecal chemotherapy [ Time Frame: From enrollment to 30 minutes after intrathecal chemotherapy ]
Central Contacts
- Seda ARDAHAN SEVGİLİ, Ph.D00902323115572
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