NCT07493018尚未招募不适用
The Effect of Hand Puppet and Squeeze Toy Techniques on Fear, Emotional Expression, and Procedure Success During Peripheral IV Catheter Placement in Pediatric Hematology-Oncology Patients: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Procedure duration
研究概览
简要总结
This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Participants will be randomized into three groups: hand puppet, squeeze toy, or control. Outcomes include fear, emotional expression, procedure duration, number of attempts, and first-attempt success.
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
- 6 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-10 years with a pediatric hematology or oncology diagnosis.
- •Cognitively able to understand instructions during the procedure.
- •Require peripheral IV catheter placement as determined by the healthcare team.
- •Difficult Intravenous Access (DIVA) Score ≥
- •Child and parent/guardian willing to participate.
排除标准
- •Physical condition preventing use of a squeeze toy.
- •Cognitive or developmental disorders preventing understanding of procedural instructions.
结局指标
主要结局
Procedure duration
时间窗: During procedure
Time from start to successful IV catheter placement.
Number of IV catheter attempts:
时间窗: During the IV procedure
Recorded for each peripheral IV catheter placement.
次要结局
- Children's Fear Scale(Measured before and immediately after IV catheter placement)
- Children's Emotional Manifestation Scale(During procedure)
研究者
Meltem Gürcan
PhD, Research Assistant
Akdeniz University
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