A Three-Arm Randomized Controlled Trial to compare the effectiveness of Yakson Touch Therapy versus Gentle Human Touch versus standard care on pain and physiological parameters during heel lancing procedure in neonates admitted in NICU at GGSMCH,Faridkot,Punjab.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pain assessment using standardized scale(Neonatal Infant Pain Scale-NIPS) during heel lancing procedure.
研究概览
简要总结
The study will be conducted to compare the effectiveness of yakson touch therapy versus gentle human touch versus standard care on pain and physiological parameters during heel lancing procedure in neonates admitted in NICU at GGSMCH, Faridkot, Punjab. The main aim of the study to compare the effectiveness of yakson touch therapy versus gentle human touch versus standard care on pain and physiological parameters in neonates admitted in NICU at GGSMCH, Faridkot, Punjab. The quantitative research approach will be used to carry out randomized control trial. The simple random sampling technique will be 72 neonates randomly allocated by SNOSE method (Group A=24, Group B=24, Group C=24) will be selected based on inclusion/exclusion criteria. The tool will consist of demographic data sheet and Neonatal Infant Pain Scale (NIPS) to assess the level of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Neonates undergoing a heel lancing procedure (blood sugar monitoring).
- •2.Neonates who will be having the first prick on heel.
- •3.Neonates who will be conscious (able to respond painful stimuli).
- •Neonates whose parents will be willing to participate.
排除标准
- •1.Neonates who will critically ill having RDS ( on ventilator or CPAP), congenital anomaly, Intraventricular hemorrhage, History of surgery or inflammation of heel.
- •2.Neonates who will be under any sedatives/ anticonvulsant drugs.
- •3.Neonates will be undergoing heel lance procedure repeated within 4 hours.
结局指标
主要结局
Pain assessment using standardized scale(Neonatal Infant Pain Scale-NIPS) during heel lancing procedure.
时间窗: 3 minutes
次要结局
- Physiological parameters(Heart rate,Respiratory rate,saturation)((Time 0 minutes)Baseline data before the intervention & immediately after the intervention(Time 3 minutes))
研究者
Ms Navpreet Kaur
Baba Farid University of Health Sciences(Faridkot)(Faridkot)