Effect of a Breathing Toy on Pain During Pediatric Venipuncture: 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
- 80
- 试验地点
- 1
- 主要终点
- Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
研究概览
简要总结
This randomized controlled trial evaluated the effectiveness of a realistic breathing toy distraction intervention on procedural pain, physiological parameters, and parental anxiety during venipuncture in children aged 1-3 years presenting to a pediatric emergency department.
Eighty children were randomly assigned to receive either a breathing toy distraction (experimental group, n=40) or standard care (control group, n=40) during blood collection. The breathing toy is a realistic plush dog that simulates breathing movements with its abdomen rising and falling while producing breathing sounds.
The primary outcome was pain intensity measured by the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale at 1 minute after the procedure. Secondary outcomes included heart rate, oxygen saturation, crying duration, and parental anxiety measured by the Beck Anxiety Inventory.
Results demonstrated significant reductions in pain scores (51% reduction), heart rate elevation, crying duration (72% reduction), and parental anxiety in the experimental group compared to the control group. No adverse events occurred. This simple, cost-effective intervention can be readily integrated into routine pediatric practice with minimal staff training.
详细描述
BACKGROUND Young children frequently experience acute procedural pain during blood collection in emergency departments. Non-pharmacological interventions, including distraction techniques, are commonly used approaches for procedural pain management. However, evidence regarding the use of breathing simulation toys in toddlers during blood collection procedures is limited. This study aims to evaluate the effect of a breathing simulation toy on procedural pain and physiological parameters in toddlers undergoing blood sampling.
INTERVENTION The breathing toy (Perfect Petzzz brand) is a plush dog (23×9×17 cm) designed to simulate breathing movements through rhythmic abdominal rise and fall accompanied by breathing sounds. The toy complies with international toy safety standards (ASTM F963, CPSIA) and is made of hypoallergenic materials.
In the experimental group, the toy was introduced approximately 5 minutes before the blood collection procedure. The child was positioned on the parent's lap, with the toy placed on the child's lap. The child's hand was gently placed on the toy's abdomen to perceive the simulated breathing movements throughout the procedure. The researcher provided verbal guidance to help maintain the child's attention on the toy.
In the control group, children received standard care without a specific distraction intervention while positioned on the parent's lap. Parental comfort measures were allowed. Environmental conditions were kept consistent between groups.
METHODOLOGY All blood collections were performed by the same pediatric nurse using a 26-gauge butterfly needle from the antecubital vein. Two independent observers blinded to group allocation assessed pain using the FLACC scale. Physiological parameters were measured using a pulse oximeter at baseline (5 minutes before the procedure) and 1 minute after the procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent or legal guardian provided written informed consent
- •Child aged 1-3 years
- •No blood sampling within the previous 6 months
- •Healthy children presenting for routine blood tests
- •No analgesic medication within 4 hours prior to the procedure
- •Child did not display fear of the breathing toy during initial introduction
- •Child had intact sensory and neurological function
排除标准
- •Chronic illness requiring regular blood sampling
- •Known developmental delay or cognitive impairment
- •Previous syncopal episode during blood collection
- •Visual impairment
- •Inability to obtain blood sample on first venipuncture attempt
- •Current acute illness requiring hospitalization
- •Use of sedatives or anxiolytics within 24 hours prior to procedure
- •Parents unable to provide informed consent in Turkish language
- •Participation in another clinical trial within 30 days
研究组 & 干预措施
Experimental: Breathing Toy Distraction
Children received a realistic breathing toy (Perfect Petzzz brand) during venipuncture. The toy was introduced 5 minutes before the procedure. The child was positioned on parent's lap with the toy on their lap. The child's hand was placed on the toy's abdomen to feel simulated breathing movements throughout the blood collection procedure. The researcher provided gentle verbal encouragement to maintain attention on the toy.
干预措施: Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection (Behavioral)
No Intervention: Standard Care
Children received standard care during venipuncture without specific distraction intervention. The child was positioned on parent's lap. Parental comfort measures (holding, talking to child) were permitted. Environmental conditions (lighting, noise, temperature) were maintained constant with the experimental group.
结局指标
主要结局
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
时间窗: 1 minute post-procedure
FLACC Pain Scale: The Face, Legs, Activity, Cry, Consolability (FLACC) scale consists of five behavioral indicators, each scored 0-2 (total range 0-10), with higher scores indicating greater pain. The FLACC Scale consists of five behavioral categories, each scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. The Turkish version has established validity and reliability.
次要结局
未报告次要终点
研究者
Özge Eda Karadağ Aytemiz
Assistant Professor
Koç University