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临床试验/NCT07145398
NCT07145398尚未招募不适用

THE EFFECT OF MANDALA PAINTING ON PAIN, STRESS, AND SLEEP QUALITY IN CHILDREN HOSPITALIZED IN THE BURN UNIT: A RANDOMIZED CONTROLLED STUDY

Yuzuncu Yıl University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
2
主要终点
Pain Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Pain Level

时间窗: 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

时间窗: 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

时间窗: Baseline and day 7

Sleep quality will be evaluated using the Children's Sleep Habits Questionnaire. Higher scores indicate poorer sleep quality.

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yusuf GÜRGAN

Student

Yuzuncu Yıl University

研究点 (2)

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