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

NCT ID: NCT07145398

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2026-06-05

Brief 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. 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.

Conditions

Pediatric Burns; Pediatric Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mandala Coloring

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

Group Type: EXPERIMENTAL

Mandala Coloring

Intervention Type: BEHAVIORAL

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 Care

Children in the control group will receive only routine burn unit care without any additional interventions. No mandala coloring sessions will be conducted.

Group Type: OTHER

Control - Standard Care

Intervention Type: OTHER

Children in the control group will receive routine burn unit care without any additional interventions. No mandala coloring sessions will be provided.

Interventions

Mandala Coloring

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.

Intervention Type: BEHAVIORAL

Control - Standard Care

Children in the control group will receive routine burn unit care without any additional interventions. No mandala coloring sessions will be provided.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Yusuf GÜRGAN

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yuzuncu Yıl University

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Yusuf GÜRGAN

Role: CONTACT

yusuf.gurgan95@gmail.com

+905442941180

Facility Contacts

RIDVAN AKDOĞAN, Assist. Prof.

Role: primary

ridvanakdogan@yyu.edu.tr

+905413980680

Other Identifiers

Van YuzuncuYıl University

Identifier Type: -

Identifier Source: org_study_id