Acute Lymphoblastic LeukemiaNCT07203742
The Effect of Mandala on Anxiety and Fear Levels in Children With Leukemia Before Intrathecal Chemotherapy Treatment
A study testing mandala painting in people with Acute Lymphoblastic Leukemia and Childhood Acute Leukemia, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Childhood Acute Leukemia, Acute Myeloblastic Leukaemia
- What is being tested?
- mandala painting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- Cases that do not meet the inclusion criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Childrens Hospital
Izmir
Seda ARDAHAN SEVGİLİ, Ph.D, 00905544318390, sedardahan@gmail.com
About this study
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.
Read the detailed description
Acute leukemia, the most common cancer in childhood (32% in girls and boys aged 0-14), is characterized by the uncontrolled and abnormal proliferation of leukocytes in the bone marrow, where blood cells are produced. Chemotherapy agents are used in its treatment. Subsequently, intrathecal chemotherapy is administered according to the child's risk group and protocol. Intrathecal chemotherapy options include intrathecal methotrexate or a combination of intrathecal methotrexate with cytarabine and hydrocortisone. Numerous complications associated with chemotherapy may occur. These complications include fatigue, nausea and vomiting, hair loss, pancytopenia, mucositis, diarrhea, and constipation. In addition, psychological side effects such as depression, anxiety, fear, and insomnia are also frequently seen in children. Non-pharmacological methods are available for managing psychological side effects in individuals diagnosed with leukemia. These methods include psychoeducation, cognitive-behavioral therapy, art therapy, supportive psychotherapy, relaxation, and distraction techniques. In addition to these methods, mandala coloring, which can be used in many different situations, is also available. This study aims to investigate the effect of mandala coloring activity on anxiety and fear levels in children with leukemia before intrathecal treatment. The study will be conducted at the Pediatric Hematology Clinic of Ege University Faculty of Medicine Children's Hospital with a total of 60 children aged 4-12 years who are scheduled for intrathecal treatment. Children aged 4-12 years who meet the inclusion criteria and who will receive intrathecal chemotherapy due to leukemia treatment will be included in the study. The "Unmatched Control Group Model" will be used in the study, and randomization will not be performed. In this design, the intervention and control groups are planned to consist of participants with similar characteristics. To prevent/minimize interaction between groups, the control group data will be collected first. After the control group data is collected, the intervention group data will be collected. Data collection and the intervention will be carried out after the children are assigned to their groups. The SPSS 26.0 software package will be used to analyze the data obtained after the study. Frequency and percentage distributions will be used to check the distribution of participants' demographic characteristics and the normality of the data. Advanced analyses will then be performed.
- Being tested
- mandala painting
- Keywords
- intrathechal chemotherapy treatment, anxiety, fear, mandala, nursing
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandala paintingOther
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
| Study group | Role | What they receive |
|---|---|---|
| mandala painting | Experimental | Not described Receives: Other: mandala painting |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of intrathecal chemotherapy
The fear that children will experience due to intrathecal chemotherapy will be collected using the "Children's Fear Scale".
Measured: 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".
Measured: From enrollment to 30 minutes after intrathecal chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start29 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA ARDAHAN SEVGİLİ, Ege University
- Investigators
- Seda Ardahan Sevgili, Ph.D., Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203742
- Sponsor's protocol ID
- 25-9.1T/59
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala on Anxiety and Fear Levels in Children With Leukemia Before Intrathecal Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT07203742
- Acronym / sponsor ID
- 25-9.1T/59
- Keywords
- intrathechal chemotherapy treatment, anxiety, fear, mandala, nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute leukemia, the most common cancer in childhood (32% in girls and boys aged 0-14), is characterized by the uncontrolled and abnormal proliferation of leukocytes in the bone marrow, where blood cells are produced. Chemotherapy agents are used in its treatment. Subsequently, intrathecal chemotherapy is administered according to the child's risk group and protocol. Intrathecal chemotherapy options include intrathecal methotrexate or a combination of intrathecal methotrexate with cytarabine and hydrocortisone. Numerous complications associated with chemotherapy may occur. These complications include fatigue, nausea and vomiting, hair loss, pancytopenia, mucositis, diarrhea, and constipation. In addition, psychological side effects such as depression, anxiety, fear, and insomnia are also frequently seen in children. Non-pharmacological methods are available for managing psychological side effects in individuals diagnosed with leukemia. These methods include psychoeducation, cognitive-behavioral therapy, art therapy, supportive psychotherapy, relaxation, and distraction techniques. In addition to these methods, mandala coloring, which can be used in many different situations, is also available. This study aims to investigate the effect of mandala coloring activity on anxiety and fear levels in children with leukemia before intrathecal treatment. The study will be conducted at the Pediatric Hematology Clinic of Ege University Faculty of Medicine Children's Hospital with a total of 60 children aged 4-12 years who are scheduled for intrathecal treatment. Children aged 4-12 years who meet the inclusion criteria and who will receive intrathecal chemotherapy due to leukemia treatment will be included in the study. The "Unmatched Control Group Model" will be used in the study, and randomization will not be performed. In this design, the intervention and control groups are planned to consist of participants with similar characteristics. To prevent/minimize interaction between groups, the control group data will be collected first. After the control group data is collected, the intervention group data will be collected. Data collection and the intervention will be carried out after the children are assigned to their groups. The SPSS 26.0 software package will be used to analyze the data obtained after the study. Frequency and percentage distributions will be used to check the distribution of participants' demographic characteristics and the normality of the data. Advanced analyses will then be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mandala painting | Experimental | Other: mandala painting |
| control | No intervention | – |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (1 listed)
- Cases that do not meet the inclusion criteria will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mandala paintingAfter 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 | Other | mandala painting |
Primary outcome
Fear of intrathecal chemotherapy
Time frame: From enrollment to 30 minutes after intrathecal chemotherapy
The fear that children will experience due to intrathecal chemotherapy will be collected using the "Children's Fear Scale".
Anxiety of intrathecal chemotherapy
Time frame: From enrollment to 30 minutes after intrathecal chemotherapy
The fear that children will experience due to intrathecal chemotherapy will be collected using the "Children's Anxiety Scale".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seda Ardahan Sevgili, Ph.D. principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mandala painting in people with Acute Lymphoblastic Leukemia and Childhood Acute Leukemia, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seda ARDAHAN SEVGİLİ, Ph.D (00902323115572 ext. 5572, sedardahan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of intrathecal chemotherapy (time frame: From enrollment to 30 minutes after intrathecal chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.