Pediatric BurnsNCT07145398
69 / 5.000 THE EFFECT OF MANDALA PAINTING ON PAIN, STRESS, AND SLEEP QUALITY IN CHILDREN HOSPITALIZED IN THE BURN UNIT: A RANDOMIZED CONTROLLED STUDY
A study testing Mandala Coloring in people with Pediatric Burns and Pediatric Burn, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The mandala coloring method allows patients to focus their attention on a circle and use colors with repetitive movements. This state of focus and relaxation can have positive effects on anxiety and other negative moods. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pediatric Burns, Pediatric Burn
- What is being tested?
- Mandala Coloring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2025to 5 Jun 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both the parent and the child are willing to participate in the study.
- Child is between 6 and 12 years of age.
- Burn degree is 1st or 2nd degree.
- The child does not have an acute psychiatric diagnosis (e.g., severe anxiety disorder, psychotic conditions).
- The child has basic fine motor skills (e.g., ability to hold a pencil, ability to color).
- The child does not have any chronic illness.
- The child has newly initiated burn treatment.
Who cannot join
- Parent or child is not willing to participate in the study.
- Burn degree is 3rd or 4th degree.
- The child has any chronic illness.
- The child has a developmental disorder.
- The child has visual perception impairments (e.g., color blindness, severe visual loss).
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
Yuzuncu Yıl University
Van, (541) 398-3680
RIDVAN AKDOĞAN, Assist. Prof., +905413980680, ridvanakdogan@yyu.edu.tr
About this study
Official title: THE EFFECT OF MANDALA PAINTING ON PAIN, STRESS, AND SLEEP QUALITY IN CHILDREN HOSPITALIZED IN THE BURN UNIT: A RANDOMIZED CONTROLLED STUDY
The mandala coloring method allows patients to focus their attention on a circle and use colors with repetitive movements. This state of focus and relaxation can have positive effects on anxiety and other negative moods. There are a limited number of studies in the literature on the use of mandala coloring in children. Therefore, the study was designed to investigate the effects of mandala coloring on pain, stress, and sleep quality in children hospitalized in the burn unit.
Read the detailed description
Skin is the largest organ in the human body and consists of three layers: the epidermis, dermis, and subcutaneous tissue. A burn is tissue damage resulting from exposure of the skin or subcutaneous tissues to factors such as heat, cold, electricity, chemicals, and radioactive rays. According to the World Health Organization (WHO), burns account for an estimated 180,000 deaths each year, with the majority of these burns occurring in low- and middle-income countries. This situation has become a significant global public health problem.
Children, with their growing and developing physiological and anatomical changes, are considered distinct organisms from adults and are significantly affected by burns. Children are at higher risk of burns due to their delicate skin, age-related differences in motor development, and limited life experiences. In 2017, approximately 84,000 children aged 0-14 were hospitalized for burn treatment in the United States. While scald burns are generally more common in young children, flame burns are more common in adolescents.
Burns are a significant medical condition that can have long-term physical and psychological effects in children. Burn injuries can lead to changes such as trauma, pain, stress symptoms, and sleep disturbances. While some burn cases can be treated on an outpatient basis, interventional procedures performed on patients admitted to a burn unit can cause increased pain. The pain felt during these procedures can sometimes be more severe than the pain felt at the time of injury. The anticipation of pain increases the level of pain felt during therapeutic procedures, creating a vicious cycle in which stress and pain amplify each other.
Sleep quality is also significantly affected in burn patients. Factors such as immobilization methods, therapeutic interventions, mechanical ventilation, and medication use can cause sleep disruption. The most common method for pain management is the use of opioid and non-opioid analgesics. However, long-term opioid use can lead to physical and psychological dependence, respiratory depression, and other side effects. Therefore, integrating non-pharmacological methods into treatment is becoming increasingly important.
Art therapy offers an effective non-pharmacological approach to alleviating the effects of traumatic experiences in children. Mandala painting allows patients to focus their attention on a circle and manipulate colors through repetitive movements. This state of focus and relaxation can have positive effects on anxiety and other negative moods. There are limited studies in the literature using mandala painting in children. Therefore, this study was designed to examine the effects of mandala painting on pain, stress, and sleep quality in children hospitalized in a burn unit.
- Conditions
- Pediatric Burns, Pediatric Burn
- Being tested
- Mandala Coloring, Control - Standard Care
- Keywords
- pediatric burn, mandala painting, paın, stress, sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ColoringBehavioural
Children hospitalized in the burn unit will participate in structured mandala coloring sessions. Each session will last approximately 30 minutes and will be conducted once daily for 7 consecutive days. Children will be provided with printed mandala patterns and coloring materials, and the sessions will be supervised by the research team. The purpose of the intervention is to reduce pain and stress levels and improve sleep quality in burn patients.
Control - Standard CareOther
Children in the control group will receive routine burn unit care without any additional interventions. No mandala coloring sessions will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Coloring | Experimental | Children hospitalized in the burn unit randomized to this group will participate in daily mandala coloring sessions. Each session will last approximately 30 minutes and will be conducted once per day for 7 consecutive days under the supervision of the research team. During these sessions, children will select and color mandala patterns using crayons or colored pencils. Standard burn unit care will also be provided Receives: Behavioral: Mandala Coloring |
| Control - Standard Care | Other | Children in the control group will receive only routine burn unit care without any additional interventions. No mandala coloring sessions will be conducted. Receives: Other: Control - Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Pain levels will be assessed using the Wong-Baker FACES Pain Rating Scale, which is validated for children. Scores range from 0 (no pain) to 10 (worst pain).
Measured: Baseline (before the intervention) and day 7
Stress Level
Stress levels will be measured using the Perceived Stress Scale for Children (ages 7-11). Higher scores indicate greater perceived stress.
Measured: Baseline and day 7
Sleep Quality
Sleep quality will be evaluated using the Children's Sleep Habits Questionnaire. Higher scores indicate poorer sleep quality.
Measured: Baseline and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion4 Jan 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric BurnsStudies 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
- Randomized controlled experimental design with pretest-posttest experiment and control group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf GÜRGAN, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145398
- Sponsor's protocol ID
- Van YuzuncuYıl University
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared with researchers who provide a methodologically sound proposal. Data will be available upon request beginning 6 months after study completion for a period of 3 years.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF MANDALA PAINTING ON PAIN, STRESS, AND SLEEP QUALITY IN CHILDREN HOSPITALIZED IN THE BURN UNIT: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07145398
- Acronym / sponsor ID
- Van YuzuncuYıl University
- Conditions
- Pediatric Burns, Pediatric Burn
- Keywords
- pediatric burn, mandala painting, paın, stress, sleep quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 4 Jan 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 28 Aug 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.
The mandala coloring method allows patients to focus their attention on a circle and use colors with repetitive movements. This state of focus and relaxation can have positive effects on anxiety and other negative moods. There are a limited number of studies in the literature on the use of mandala coloring in children. Therefore, the study was designed to investigate the effects of mandala coloring on pain, stress, and sleep quality in children hospitalized in the burn unit.
Detailed description
Skin is the largest organ in the human body and consists of three layers: the epidermis, dermis, and subcutaneous tissue. A burn is tissue damage resulting from exposure of the skin or subcutaneous tissues to factors such as heat, cold, electricity, chemicals, and radioactive rays. According to the World Health Organization (WHO), burns account for an estimated 180,000 deaths each year, with the majority of these burns occurring in low- and middle-income countries. This situation has become a significant global public health problem.
Children, with their growing and developing physiological and anatomical changes, are considered distinct organisms from adults and are significantly affected by burns. Children are at higher risk of burns due to their delicate skin, age-related differences in motor development, and limited life experiences. In 2017, approximately 84,000 children aged 0-14 were hospitalized for burn treatment in the United States. While scald burns are generally more common in young children, flame burns are more common in adolescents.
Burns are a significant medical condition that can have long-term physical and psychological effects in children. Burn injuries can lead to changes such as trauma, pain, stress symptoms, and sleep disturbances. While some burn cases can be treated on an outpatient basis, interventional procedures performed on patients admitted to a burn unit can cause increased pain. The pain felt during these procedures can sometimes be more severe than the pain felt at the time of injury. The anticipation of pain increases the level of pain felt during therapeutic procedures, creating a vicious cycle in which stress and pain amplify each other.
Sleep quality is also significantly affected in burn patients. Factors such as immobilization methods, therapeutic interventions, mechanical ventilation, and medication use can cause sleep disruption. The most common method for pain management is the use of opioid and non-opioid analgesics. However, long-term opioid use can lead to physical and psychological dependence, respiratory depression, and other side effects. Therefore, integrating non-pharmacological methods into treatment is becoming increasingly important.
Art therapy offers an effective non-pharmacological approach to alleviating the effects of traumatic experiences in children. Mandala painting allows patients to focus their attention on a circle and manipulate colors through repetitive movements. This state of focus and relaxation can have positive effects on anxiety and other negative moods. There are limited studies in the literature using mandala painting in children. Therefore, this study was designed to examine the effects of mandala painting on pain, stress, and sleep quality in children hospitalized in a burn unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled experimental design with pretest-posttest experiment and control group
| Arm | Type | Receives |
|---|---|---|
| Mandala Coloring | Experimental | Behavioral: Mandala ColoringChildren hospitalized in the burn unit randomized to this group will participate in daily mandala coloring sessions. Each session will last approximately 30 minutes and will be conducted once per day for 7 consecutive days under the supervision of the research team. During these sessions, children will select and color mandala patterns using crayons or colored pencils. Standard burn unit care will also be provided |
| Control - Standard Care | Other | Other: Control - Standard CareChildren in the control group will receive only routine burn unit care without any additional interventions. No mandala coloring sessions will be conducted. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Both the parent and the child are willing to participate in the study.
- Child is between 6 and 12 years of age.
- Burn degree is 1st or 2nd degree.
- The child does not have an acute psychiatric diagnosis (e.g., severe anxiety disorder, psychotic conditions).
- The child has basic fine motor skills (e.g., ability to hold a pencil, ability to color).
Key exclusion criteria (5 listed)
- Parent or child is not willing to participate in the study.
- Burn degree is 3rd or 4th degree.
- The child has any chronic illness.
- The child has a developmental disorder.
- The child has visual perception impairments (e.g., color blindness, severe visual loss).
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 ColoringChildren hospitalized in the burn unit will participate in structured mandala coloring sessions. Each session will last approximately 30 minutes and will be conducted once daily for 7 consecutive days. Children will be provided with printed mandala patterns and coloring materials, and the sessions will be supervised by the research team. The purpose of the intervention is to reduce pain and stress levels and improve sleep quality in burn patients. | Behavioural | Mandala Coloring |
| Control - Standard CareChildren in the control group will receive routine burn unit care without any additional interventions. No mandala coloring sessions will be provided. | Other | Control - Standard Care |
Primary outcome
Pain Level
Time frame: Baseline (before the intervention) and day 7
Pain levels will be assessed using the Wong-Baker FACES Pain Rating Scale, which is validated for children. Scores range from 0 (no pain) to 10 (worst pain).
Stress Level
Time frame: Baseline and day 7
Stress levels will be measured using the Perceived Stress Scale for Children (ages 7-11). Higher scores indicate greater perceived stress.
Sleep Quality
Time frame: Baseline and day 7
Sleep quality will be evaluated using the Children's Sleep Habits Questionnaire. Higher scores indicate poorer sleep quality.
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 28 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared with researchers who provide a methodologically sound proposal. Data will be available upon request beginning 6 months after study completion for a period of 3 years.
Related trials for Pediatric Burns
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
Not yet recruiting
Comparison of Topical Antibiotics Versus Systemic Antibiotics in Preventing Burn Wound Infection in Pediatric Burn Patients
Burn
Not yet recruitingPhase 1
Magnesium Sulfate in Pediatric Burn Dressing Changes
Pediatric Burns
Not yet recruitingObservational study
Phoenixin and Pain in Pediatric Burn Patients
Children, Acute Pain
Not yet recruiting
VR-PAT and fNIRS to Identify CNS Biomarkers of Pain
Acute Pain, Pediatric ALL
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.
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 Coloring in people with Pediatric Burns and Pediatric Burn, 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 Aug 2025. 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 Yusuf GÜRGAN (+905442941180, yusuf.gurgan95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Baseline (before the intervention) and day 7). The study lists 3 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 28 Aug 2025.