Effect of Kaleidoscope and Helicone Use on Pain and Anxiety During Venipuncture in School-Age 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
- 210
- 试验地点
- 2
- 主要终点
- Pain level measured using Wong-Baker FACES Pain Scale
研究概览
简要总结
This randomized controlled trial aimed to evaluate the effects of kaleidoscope and helicone distraction tools on pain and anxiety levels during venipuncture in school-age children. The study was conducted at Ankara Etlik City Hospital Pediatric Emergency Department between April and May 2025. A total of 210 children aged 6 to 12 years who were undergoing venous blood sampling for the first time were randomly assigned to one of three groups: Kaleidoscope, Helicone, or Control (standard care). The Kaleidoscope group used a passive distraction tool featuring dynamic visual patterns; the Helicone group used an active distraction tool that involves hand manipulation of a rotating toy. Pain levels were measured using the Wong-Baker FACES Pain Rating Scale, and anxiety levels were assessed using the Children's Anxiety Meter-State (CAM-S). Measurements were taken before, during, and after the procedure. This study seeks to determine the comparative effectiveness of active versus passive distraction techniques in pediatric procedural pain and anxiety management. All interventions were non-pharmacological, non-invasive, and conducted in a safe clinical setting with informed consent obtained from both children and their guardians.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 6 and 12 years
- •Requiring venipuncture for clinical purposes
- •Able to verbally communicate pain and anxiety
- •Accompanied by a parent or legal guardian who provides written informed consent
- •Child provides verbal assent to participate
排除标准
- •Children with cognitive or neurological disorders affecting pain or anxiety perception
- •Use of any analgesics, anxiolytics, or sedatives within 6 hours prior to the procedure
- •Visual or hearing impairments that interfere with the use of kaleidoscope or helicone
- •Previous experience with similar distraction tools
- •Presence of any skin condition preventing pain scale assessment
结局指标
主要结局
Pain level measured using Wong-Baker FACES Pain Scale
时间窗: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Pain was assessed by the child using the Wong-Baker FACES Pain Rating Scale. This scale ranges from 0 to 10, where higher scores indicate more severe pain. Evaluations were conducted at three time points: before the procedure, during needle insertion, and two minutes after.
Anxiety level measured using Children's Anxiety Meter - State (CAM-S)
时间窗: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Anxiety was evaluated using the Children's Anxiety Meter - State (CAM-S) tool. The scale ranges from 0 (no anxiety) to 10 (extreme anxiety). Assessments were completed by the child with assistance from the researcher at three time points: before, during, and after the venipuncture.
次要结局
未报告次要终点
研究者
AYLİN ARIKAN
Doctor of Philosophy in Pediatric Nursing
Ankara University