Effect of Immersive Cartoon Projection and Ball Squeezing on Pain During Venipuncture Among Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Analogue Scale (VAS) Pain Score (0-10; higher scores = worse pain)
研究概览
简要总结
The goal of this clinical trial is to learn which distraction method works better to reduce needle pain in children aged 4-12 years during blood draws.
The main questions it aims to answer are:
- Does watching cartoon videos lower children's pain more than squeezing a stress ball?
- Which method do parents prefer for their children?
120 children will be randomly assigned to watch cartoons or squeeze a ball while nurses draw blood. Pain will be measured using a 0-10 pain scale right after the needle.
This study will help nurses choose the best way to make blood draws less painful for children.
详细描述
This study compares two distraction methods (cartoon projection vs. ball squeezing) to reduce venipuncture pain in children aged 4-12 years.
120 children will be randomized 1:1 to receive either immersive cartoon videos or tactile stress ball distraction during routine blood draws at Karbala Pediatric Hospital.
Pain intensity (primary outcome) will be assessed using Visual Analogue Scale (VAS, 0-10; higher=worse) immediately post-procedure.
The study protocol received ethical approval from University of Baghdad College of Nursing (No. 77, Jan 29, 2026).
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
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-12 years
- •Requiring venipuncture for routine blood testing
- •Able to watch cartoon video during procedure
- •Parental consent obtained
排除标准
- •Developmental delay preventing cooperation
- •Severe anxiety disorder
- •Visual impairment
- •Non-English/Arabic speaking parents
研究组 & 干预措施
Cartoon Projection Arm
Children receive immersive cartoon projection distraction during venipuncture
干预措施: Cartoon Projection Distraction (Behavioral)
Cartoon Projection Arm
Children receive immersive cartoon projection distraction during venipuncture
干预措施: ball squeezing distraction (Behavioral)
ball squeezing arm
Children aged 4-12 years receive ball squeezing distraction during venipuncture
干预措施: ball squeezing distraction (Behavioral)
结局指标
主要结局
Analogue Scale (VAS) Pain Score (0-10; higher scores = worse pain)
时间窗: 0-30 seconds post - venipuncture
Child rates pain intensity (0-10 cm scale) immediately after needle insertion
次要结局
- Nurse-Observed Anxiety Level (1-5 scale; higher = worse)(During venipuncture procedure)
研究者
Enas Ahmed Abdul Kareem
Principal Investigator
University of Baghdad