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临床试验/CTRI/2020/12/029710
CTRI/2020/12/029710尚未招募不适用

TO ASSESS THE EFFICACY OF VIBRATION DEVICE IN REDUCTION OF INJECTION PAIN AMONG CHILDREN

Prof Archana Maurya1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年1月1日最近更新:

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)

研究者

发起方
Prof Archana Maurya
申办方类型
Other [Other [Self sponsored]]

研究点 (1)

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