The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- procedure-related pain with Wong Baker Pain Rating Scale
研究概览
简要总结
This study aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention.
详细描述
Before and during subcutaneous injection administration to the children in the study group There will be a puppet show. No distraction method will be applied to the children in the control group and the clinical A subcutaneous injection will be administered in accordance with the routine. Pain and fear assessment of children in both groups will be evaluated by the clinical nurse during the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child <3 and >7 years old
- •Medically unstable (dehydration, septic shock, sedation)
- •Children who are being treated for leukemia in the Pediatric Hematology Service will be included in the study.
排除标准
- •Not exposed to any other interventional procedure before (same day) subcutaneous intervention
- •Not expressing any pain before subcutaneous intervention
- •Heart rate to be within age-appropriate limits
- •Wong-Baker Pain Rating Scale score of 0 in the evaluation performed before the subcutaneous intervention (5 minutes ago)
- •Having a disability that cannot perceive the attempt and communicate (down syndrome, speech disorder, visual impairment)
- •The child and family do not know Turkish
结局指标
主要结局
procedure-related pain with Wong Baker Pain Rating Scale
时间窗: change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
pain assessment with Wong Baker Pain Rating Scale by child
procedure-related fear with Child Fear Scale
时间窗: change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
fear assessment with Child Fear Scale by child and parent
procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
时间窗: change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse
次要结局
- Heart rate(change from the heart rate at 10 minutes)
研究者
Gülçin Özalp Gerçeker
pHD, Assoc. Prof.
Dokuz Eylul University