Childhood CancersNCT07363005
Parent-Child Mandala Painting During Chemotherapy
A study testing Parent-Child Mandala Painting Intervention in people with Childhood Cancers and Pediatric Oncology, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of a parent-child mandala painting intervention conducted during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels in pediatric oncology patients. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Childhood Cancers, Pediatric Oncology
- What is being tested?
- Parent-Child Mandala Painting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2025to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 5 and 12 years who are receiving chemotherapy.
- One parent or primary caregiver willing to participate with the child.
- Ability of the child to perform basic fine motor activities such as holding a pencil and coloring.
- Absence of an acute psychiatric diagnosis in the child (e.g., severe anxiety disorder, psychotic disorders).
- Willingness of both the child and the parent to participate in the study.
Who cannot join
- Children diagnosed with stage III or stage IV cancer.
- Presence of visual perception impairments in the child (e.g., color blindness, severe visual impairment).
- Refusal of the child or parent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Dursun Odabas Medical Center
Van, Turkey, 65090
About this study
Official title: Effects of a Parent-Child Mandala Painting Intervention During Chemotherapy on Caregiver Burden, Psychological Well-being, and Child Fear and Pain: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of a parent-child mandala painting intervention conducted during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels in pediatric oncology patients.
Childhood cancer and its treatment are highly stressful experiences for both children and their parents. Chemotherapy-related side effects such as pain, fear, and emotional distress may negatively affect children's psychological well-being and treatment adaptation. Parents, as primary caregivers, often experience increased emotional burden, anxiety, and stress during this process.
Read more
The intervention consists of a structured parent-child mandala painting activity delivered over a two-week period, with six sessions in total, each lasting 30 minutes. Participants are randomly assigned to either the intervention group, which receives the mandala painting activity in addition to routine care, or the control group, which receives routine nursing care alone.
Outcome measures include child fear and pain levels assessed using validated pediatric scales, as well as caregiver burden and psychological distress measured through standardized questionnaires. Assessments are conducted at baseline and after completion of the two-week intervention period.
This study seeks to contribute evidence on the use of creative, non-pharmacological interventions to support emotional well-being in children undergoing chemotherapy and their caregivers.
Read the detailed description
This study is designed as a randomized controlled trial to examine the effects of a parent-child mandala painting intervention during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels.
The study population consists of children aged 5-12 years who are receiving chemotherapy treatment in a pediatric hematology-oncology unit and their primary caregivers. Following eligibility screening and informed consent, eligible parent-child dyads are randomly assigned to either the intervention group or the control group using an urn randomization method to ensure equal allocation.
Participants in the intervention group engage in a parent-child mandala painting activity in addition to routine nursing care. The intervention is delivered over a two-week period, consisting of six sessions, each lasting approximately 30 minutes. During each session, children and their parents are provided with mandala coloring sheets and colored markers and are encouraged to paint together in a quiet and supportive hospital environment. The activity aims to promote emotional expression, relaxation, and positive parent-child interaction during chemotherapy.
The control group receives routine nursing care without any additional structured intervention during the same two-week period. After completion of outcome assessments, participants in the control group are also offered the mandala painting activity in accordance with ethical principles.
Primary outcome measures include child fear and pain levels, assessed using the Child Fear Scale and the Wong-Baker Faces Pain Rating Scale. Secondary outcome measures include caregiver burden and psychological distress, measured using the Zarit Caregiver Burden Scale and the Depression Anxiety Stress Scale (DASS-21).
Outcome assessments are conducted at baseline prior to the intervention and at the end of the two-week intervention period. Data are analyzed to compare changes in outcome measures between the intervention and control groups.
This study aims to provide evidence regarding the effectiveness of a non-pharmacological, creative intervention in reducing psychological distress and improving emotional well-being among children undergoing chemotherapy and their caregivers.
- Conditions
- Childhood Cancers, Pediatric Oncology
- Being tested
- Parent-Child Mandala Painting Intervention
- Keywords
- Mandala painting, Art therapy, Pediatric chemotherapy, Caregiver burden, Child fear, Pain management, Non-pharmacological intervention, Parent-child interaction
- Medical subject headings
- Caregiver Burden, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Mandala Painting InterventionBehavioural
This behavioral intervention involves structured parent-child mandala painting sessions conducted during the chemotherapy process. The intervention aims to support children's emotional well-being and fine motor skills while enhancing parent-child interaction. Sessions are delivered over a two-week period, with a total of six sessions, each lasting approximately 30 minutes, and are facilitated by a trained nurse.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Painting Group | Experimental | Participants in this arm receive a structured parent-child mandala painting intervention in addition to routine nursing care during the chemotherapy process. The intervention is delivered over two weeks, consisting of six sessions, each lasting approximately 30 minutes. Receives: Behavioral: Parent-Child Mandala Painting Intervention |
| Control Group | No intervention | Participants in this arm receive routine nursing care during the chemotherapy process without any additional structured intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Pain Level
Change in children's pain level measured using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated pediatric pain assessment tool consisting of six facial expressions representing increasing pain intensity. The scale is scored from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores represent greater pain intensity.
Measured: Baseline and at the end of the 2-week intervention period
Children's Fear Level
Change in children's fear level measured using the Children's Fear Scale (CFS), a single-item observational scale designed to assess fear in children. The scale ranges from 0 to 4, where 0 represents "no fear" and 4 represents "extreme fear." Higher scores indicate higher levels of fear.
Measured: Baseline and at the end of the 2-week intervention period
Secondary outcomes (2)
Caregiver Burden
Change in caregiver burden measured using the Zarit Burden Interview (ZBI), a widely used self-report questionnaire assessing the perceived burden of caregivers. The scale consists of 22 items with total scores ranging from 0 to 88, where higher scores indicate greater caregiver burden.
Measured: Baseline and at the end of the 2-week intervention period
Parental Psychological Distress
Change in parental psychological distress measured using the Depression Anxiety Stress Scale-21 (DASS-21), a self-report instrument assessing symptoms of depression, anxiety, and stress. Total scores range from 0 to 63, with higher scores indicating greater psychological distress.
Measured: Baseline and at the end of the 2-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start22 Nov 2025
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancersStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either an intervention group receiving a parent-child mandala painting activity in addition to routine care or a control group receiving routine care alone.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rıdvan Akdogan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363005
- Sponsor's protocol ID
- YYU-MANDALA-ONCO-01
- Status last verified
- May 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the sensitive nature of the study population, which includes pediatric patients undergoing chemotherapy and their caregivers. The data contain personal and psychological assessment information, and sharing IPD could pose risks to participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Parent-Child Mandala Painting Intervention During Chemotherapy on Caregiver Burden, Psychological Well-being, and Child Fear and Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07363005
- Acronym / sponsor ID
- YYU-MANDALA-ONCO-01
- Conditions
- Childhood Cancers, Pediatric Oncology
- Keywords
- Mandala painting, Art therapy, Pediatric chemotherapy, Caregiver burden, Child fear, Pain management, Non-pharmacological intervention, Parent-child interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 23 Jan 2026 (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 randomized controlled trial aims to evaluate the effects of a parent-child mandala painting intervention conducted during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels in pediatric oncology patients.
Childhood cancer and its treatment are highly stressful experiences for both children and their parents. Chemotherapy-related side effects such as pain, fear, and emotional distress may negatively affect children's psychological well-being and treatment adaptation. Parents, as primary caregivers, often experience increased emotional burden, anxiety, and stress during this process.
The intervention consists of a structured parent-child mandala painting activity delivered over a two-week period, with six sessions in total, each lasting 30 minutes. Participants are randomly assigned to either the intervention group, which receives the mandala painting activity in addition to routine care, or the control group, which receives routine nursing care alone.
Outcome measures include child fear and pain levels assessed using validated pediatric scales, as well as caregiver burden and psychological distress measured through standardized questionnaires. Assessments are conducted at baseline and after completion of the two-week intervention period.
This study seeks to contribute evidence on the use of creative, non-pharmacological interventions to support emotional well-being in children undergoing chemotherapy and their caregivers.
Detailed description
This study is designed as a randomized controlled trial to examine the effects of a parent-child mandala painting intervention during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels.
The study population consists of children aged 5-12 years who are receiving chemotherapy treatment in a pediatric hematology-oncology unit and their primary caregivers. Following eligibility screening and informed consent, eligible parent-child dyads are randomly assigned to either the intervention group or the control group using an urn randomization method to ensure equal allocation.
Participants in the intervention group engage in a parent-child mandala painting activity in addition to routine nursing care. The intervention is delivered over a two-week period, consisting of six sessions, each lasting approximately 30 minutes. During each session, children and their parents are provided with mandala coloring sheets and colored markers and are encouraged to paint together in a quiet and supportive hospital environment. The activity aims to promote emotional expression, relaxation, and positive parent-child interaction during chemotherapy.
The control group receives routine nursing care without any additional structured intervention during the same two-week period. After completion of outcome assessments, participants in the control group are also offered the mandala painting activity in accordance with ethical principles.
Primary outcome measures include child fear and pain levels, assessed using the Child Fear Scale and the Wong-Baker Faces Pain Rating Scale. Secondary outcome measures include caregiver burden and psychological distress, measured using the Zarit Caregiver Burden Scale and the Depression Anxiety Stress Scale (DASS-21).
Outcome assessments are conducted at baseline prior to the intervention and at the end of the two-week intervention period. Data are analyzed to compare changes in outcome measures between the intervention and control groups.
This study aims to provide evidence regarding the effectiveness of a non-pharmacological, creative intervention in reducing psychological distress and improving emotional well-being among children undergoing chemotherapy and their caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either an intervention group receiving a parent-child mandala painting activity in addition to routine care or a control group receiving routine care alone.
| Arm | Type | Receives |
|---|---|---|
| Mandala Painting Group | Experimental | Behavioral: Parent-Child Mandala Painting InterventionParticipants in this arm receive a structured parent-child mandala painting intervention in addition to routine nursing care during the chemotherapy process. The intervention is delivered over two weeks, consisting of six sessions, each lasting approximately 30 minutes. |
| Control Group | No intervention | –Participants in this arm receive routine nursing care during the chemotherapy process without any additional structured intervention during the study period. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 5 and 12 years who are receiving chemotherapy.
- One parent or primary caregiver willing to participate with the child.
- Ability of the child to perform basic fine motor activities such as holding a pencil and coloring.
- Absence of an acute psychiatric diagnosis in the child (e.g., severe anxiety disorder, psychotic disorders).
- Willingness of both the child and the parent to participate in the study.
Key exclusion criteria (3 listed)
- Children diagnosed with stage III or stage IV cancer.
- Presence of visual perception impairments in the child (e.g., color blindness, severe visual impairment).
- Refusal of the child or parent to participate in 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 |
|---|---|---|
| Parent-Child Mandala Painting InterventionThis behavioral intervention involves structured parent-child mandala painting sessions conducted during the chemotherapy process. The intervention aims to support children's emotional well-being and fine motor skills while enhancing parent-child interaction. Sessions are delivered over a two-week period, with a total of six sessions, each lasting approximately 30 minutes, and are facilitated by a trained nurse. | Behavioural | Mandala Painting Group |
Primary outcome
Children's Pain Level
Time frame: Baseline and at the end of the 2-week intervention period
Change in children's pain level measured using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated pediatric pain assessment tool consisting of six facial expressions representing increasing pain intensity. The scale is scored from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores represent greater pain intensity.
Children's Fear Level
Time frame: Baseline and at the end of the 2-week intervention period
Change in children's fear level measured using the Children's Fear Scale (CFS), a single-item observational scale designed to assess fear in children. The scale ranges from 0 to 4, where 0 represents "no fear" and 4 represents "extreme fear." Higher scores indicate higher levels of fear.
2 secondary outcomes
Caregiver Burden
Time frame: Baseline and at the end of the 2-week intervention period
Parental Psychological Distress
Time frame: Baseline and at the end of the 2-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the sensitive nature of the study population, which includes pediatric patients undergoing chemotherapy and their caregivers. The data contain personal and psychological assessment information, and sharing IPD could pose risks to participant privacy and confidentiality.
Related trials for Childhood Cancers
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
Not yet recruiting
Pilot Testing ACCOMPANI: A Nurse-Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology
Pediatric Oncology, Childhood Cancers
Recruiting
COMUNICAR: Community-Led Family-Centered Communication for Cancer Survivorship Care
Childhood Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Mandala Painting Intervention in people with Childhood Cancers and Pediatric Oncology, run by Yuzuncu Yil 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 5 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Pain Level (time frame: Baseline and at the end of the 2-week intervention period). 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 5 May 2026.