Clinical efficacy of external cold and vibrating device in decreasing pain in children undergoing venipuncture in paediatric hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To evaluate efficacy of external cold and vibrating device in decreasing pain during venipuncturr compared to standard care in tge age group of 3 to 12 yearts admitted in paediatric surgical wards as assessed by modified wong baker scale and numerical rating scales of pain.
研究概览
简要总结
Dear sir or madam
This is a study titled Clinical efficacy of external cold and vibrating device in decreasing pain in children undergoing venipuncture in a paediatric hospital
Needle prick procedures like IV cannulation and venipunctures are essential for diagnosis and treatment for children in hospitals but at the same time most distressful events and this can impact children both emotionally and pscycologically
In this study we use an external cold and vibrating device versus standard hospital care for needle pricks like venipuncture to asses how useful is this device in reduction of pain compared to standard care like distraction while needle pricks
We include children between 3 to 12 years with at least one caregiver and exclude all the children with critical illnesses including bleeding disorders or neuropathy
primary outcome is to evaluate efficacy of the device in reduction of pain as assessed by pain scores and secondary outcomes are to assess acceptance of the device with appropriate likert questionnaire and to assess the level of anxiety of children undergoing venipuncture using children fear scale
randomised active parellel study which is open label
randomisation will be done by computer generated envelopes
sample size was calculated by a pilot study and the sample size is 72 with 36 in each group
ethical committee approval is attatched in this application
kindly do the needful
thank you
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •presence of atleast one parent/ care giver.
排除标准
- •Cghildren with significant altered emotional state, cognitive dysfunction, who refuse to wear device, with bleeding disorders, with neuropathy/ nerve damage, who are critically ill/ unstable.
- •absence of atleast one parent or caregiver, lack of parental consent.
结局指标
主要结局
To evaluate efficacy of external cold and vibrating device in decreasing pain during venipuncturr compared to standard care in tge age group of 3 to 12 yearts admitted in paediatric surgical wards as assessed by modified wong baker scale and numerical rating scales of pain.
时间窗: During or immidiately after the procedure, once only.
次要结局
- To assess the acceptance of the device using appropriate likert questionnaire(and to assess the level of anxiety in children undergoing cannulation using children fear scale)
研究者
Dr Sharadha M
indira gandhi institute of child health, bengaluru