The Effect of Mandala on Anxiety and Fear Levels in Children With Leukemia Before Intrathecal Che… (NCT07203742) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Mandala on Anxiety and Fear Levels in Children With Leukemia Before Intrathecal Chemotherapy Treatment
Turkey (Türkiye)60 participantsStarted 2025-09-29
Plain-language 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fear of intrathecal chemotherapy
Timeframe: From enrollment to 30 minutes after intrathecal chemotherapy
2
Anxiety of intrathecal chemotherapy
Timeframe: From enrollment to 30 minutes after intrathecal chemotherapy