A Randomized Control Trial To Assess Effectiveness Of External Cold And Thermomechanical Stimulation On Anxiety And Pain During Intravenous Cannulation Among Children At All India Institute Of Medical Sciences, Rishikesh
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fear and anxiety with Children fear scale and pain with FLACC behavioral pain assessment scale
研究概览
简要总结
This is a Parallel group, single blinded randomized control trial to assess the efficacy of external cold and thermomechanical stimulation on anxiety and pain during intravenous cannulation that will be conducted in the Pediatric Department of AIIMS Rishikesh. The primary outcome will be significant reduction on level of anxiety and pain during Intravenous cannulation among children by using external cold and thermomechanical stimulation through Buzzy device at p<0.05 level. The secondary outcome will be significant association of post interventional level of anxiety and pain among children with their selected demographic data at p<0.05 level
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Study includes: Children of age 6 to12 yearswho require Intravenous Cannulation Children undergoing first time intravenous Cannulation.
排除标准
- •Study excludes child who is having: Break or abrasion on the skin where the device will be placed Nerve damage in the affected extremity Critical or chronic illness or neurodevelopmental delay.
- •History of use of analgesic within the last 6 hours History of syncope due to blood sampling collection or immunization.
结局指标
主要结局
Fear and anxiety with Children fear scale and pain with FLACC behavioral pain assessment scale
时间窗: 3-5 MIN.
次要结局
- Significant association of post interventional level of anxiety and pain among children with their selected demographic data at p0.05 level(3- 5 MIN.)