The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Fear Level Assessed by the Children's Fear Scale
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Burn dressing is often a distressing and painful procedure for pediatric patients, which may lead to increased anxiety, physiological instability, and negative treatment experiences.
In this study, child-friendly cartoon-printed adhesive bands are used as a non-pharmacological intervention to provide distraction and emotional comfort during burn dressing. By incorporating familiar and visually engaging designs, the intervention seeks to reduce children's perception of pain, alleviate stress, and improve physiological stability (heart rate, oxygen saturation, and respiratory rate) during the procedure.
Participants will include children aged 7-11 years receiving burn care in a pediatric burn unit. They will be randomly assigned to either the intervention group (cartoon-printed band use) or the control group (standard plain band use). Fear, pain, and stress will be assessed using validated scales before, during, and after the dressing procedure. Physiological parameters will be measured using a pulse oximeter.
The study is expected to contribute to the development of child-centered, non-pharmacological methods that make medical procedures less stressful and more tolerable for pediatric patients. Results may guide the design of more comforting and engaging treatment environments in pediatric burn care.
详细描述
Burn injuries are among the most common causes of hospitalization in children and often require repeated painful dressing changes. These procedures can provoke significant fear, stress, and pain, negatively affecting children's cooperation, recovery, and overall treatment experience. Traditional approaches to pain management in burn care frequently rely on pharmacological methods, which may have limitations or adverse effects. Therefore, complementary, non-pharmacological interventions are needed to support children during painful procedures.
The CARE-BURN Trial investigates the impact of using cartoon character-printed adhesive bands as a simple, visual, and child-friendly distraction tool during burn dressing. The intervention is designed to create a more comforting and engaging environment for the child by integrating familiar cartoon images into the medical materials. The visual appeal of the bands is expected to distract children's attention from the painful stimulus, enhance their sense of security, and reduce anxiety and perceived pain intensity.
This randomized controlled study includes children aged 7-11 years who are receiving inpatient or outpatient burn treatment. Participants will be randomly assigned using the Urn randomization method to one of two groups:
Intervention Group: Dressing with cartoon character-printed adhesive bands
Control Group: Dressing with standard plain adhesive bands
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Participants, care providers, and outcome assessors will be aware of group allocation due to the visible appearance of the cartoon character-printed bands used during the burn dressing procedure.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 11 years at the time of enrollment.
- •Hospitalized children diagnosed with superficial partial-thickness or deep partial-thickness burns (second-degree burns).
- •Total Burned Body Surface Area (TBSA) ≤ 10%, calculated using the Rule of Nines or Lund-Browder chart.
- •Burn location limited to upper extremities, lower extremities, or trunk.
- •Scheduled to undergo routine burn dressing procedures in the pediatric ward.
- •Ability of the child to communicate pain and anxiety verbally.
- •Written informed consent obtained from parent or legal guardian, and assent from the child when appropriate.
排除标准
- •Children with full-thickness (third-degree) or fourth-degree burns.
- •Burns involving the face, scalp, neck, or genital region.
- •TBSA > 10%.
- •Presence of cognitive impairment, developmental delay, or neurological disorder that may interfere with outcome assessment.
- •Presence of chronic pain conditions or regular use of analgesics unrelated to burn treatment.
- •Initial burn dressing performed in an intensive care unit (ICU).
- •Refusal of the child or parent/legal guardian to participate.
研究组 & 干预措施
Cartoon character-printed band
Children receiving burn dressing with cartoon character-printed elastic bands.
干预措施: Cartoon-printed band application (Other)
Standard Band Group
Children receiving burn dressing with standard plain elastic bands.
干预措施: Standard band application (Other)
结局指标
主要结局
Fear Level Assessed by the Children's Fear Scale
时间窗: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Assessed using the Children's Fear Scale . Measures the level of fear experienced by children during burn dressing procedures, scored from 0 (no fear) to 4 (highest fear).
次要结局
- Stress Level Assessed by the Perceived Stress Scale for Children (PeSSKi)(Baseline (immediately before burn dressing) and immediately after burn dressing procedure)
- Oxygen Saturation During Burn Dressing(Baseline (immediately before burn dressing) and immediately after burn dressing procedure)
- Pain Intensity Assessed by the Wong-Baker Faces Pain Scale(Baseline (immediately before burn dressing) and immediately after burn dressing procedure)
- Heart Rate During Burn Dressing(Baseline (immediately before burn dressing) and during burn dressing procedure)
- Respiratory Rate During Burn Dressing(Baseline (immediately before burn dressing) and during burn dressing procedure)
- Body Temperature During Burn Dressing(Baseline (immediately before burn dressing) and immediately after burn dressing procedure)
研究者
Rıdvan Akdogan
Assist. Prof. (PhD)
Yuzuncu Yil University