TO ASSESS THE EFFICACY OF VIBRATION DEVICE IN REDUCTION OF INJECTION PAIN AMONG CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- assess anxiety level through Children’s emotional behaviour scale
研究概览
简要总结
To assess the efficacy of Vibration device in reduction of Injection pain in children. This study is a randomized, participant blinde, sealed opaque envelope, two group one control group and interventional trail comparing assess the pain level, anxiety level respiration heart rate and SpO2 . Study have three phases –1. ASSESSMENT & PLANNING PHASE: The investigator will visit the AVBR hospital in advance and obtain the necessary permission from the concerned authorities. The investigator will introduce him and inform the child’s parent about the nature of the study so as to ensure better co-operation during the data collection.**2.****IMPLEMENTATION PHASE:**Vibration device is placed by attaching it to the injection site holding it in place, as close as possible above the needle insertion site and activate The device has to be kept in place throughout the procedure In experimental group and control group, only rub by palm on injection site no intervention will be given during administration of injection in children.3. EVALUATION PHASE: The outcome measures pain in children during injection and were recorded and assessed by a blinded observer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 8.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Child who are in pediatric unit.
- •Those children are fully conscious.
- •Parent’s who have willing to their child participate in study.
排除标准
- •Those children are admitted in PICU with ventilator support.
- •Those children are mentally handicaps.
- •Extensive hospitalization for chronic illness Those children having neuro-behaviour disorders (Paralysis, Cerebral palsy) Those children having behaviour problem (Autism, temper tantrum, ADHD).
- •Those children having injection side abscess or any complication.
- •Past history of surgery.
结局指标
主要结局
assess anxiety level through Children’s emotional behaviour scale
时间窗: Before, during and after injection
assess reduction of injection pain in children (Wong-Baker FACES pain rating scale).
时间窗: Before, during and after injection
次要结局
- Pulse or Heart Rate(SpO2 saturation)
