The Effect of Cold Application and Vibration in Reducing Pain During Vaccination in Children: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Wong-Baker FACES Pain Rating Scale
研究概览
简要总结
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of using Cold Application and Vibration in reducing pain during routine vaccination in children.
详细描述
In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain.In light of this information, this study aimed to examine the effect of by using Cold Application and Vibration in reducing pain during routine vaccination in children. Cold Application and Vibration will be done with BUZZY.
This study is a prospective, randomized and controlled trial. Children aged 13 years who required routine vaccination were divided into three groups; placed under arm Buzzy, placed in standard Buzzy, and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who selfreported using Wong-Baker FACES.
The study population consisted of the children's during routine vaccination in children aged 13 years. Sample of the study consisted of a total of 90 children who met the sample selection criteria and were selected via randomization method.
Children were randomized into three groups; placed under arm Buzzy (n:30), placed in standard Buzzy (n:30), and Control (n:30). Data were collected using the Interview and Observation Form and Wong-Baker FACES Pain Rating Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children the ages of 13 years (planned to be included in the vaccination calendar program),
- •Volunteering of the child and parent to participate in the study,
- •Healthy children,
- •Vaccination should be done by the same nurse,
排除标准
- •The child has any acute or chronic disease,
- •The child has a mental disability, vision, speech or communication problems,
- •The parent has hearing, vision or verbal communication difficulties,
- •The child used analgesics in the last 6 hours,
- •Infection, disruption of skin integrity and rash in the area where theapplication will be made,
- •Exclusion criteria were that the parent or child wanted to leave the study at any point.
结局指标
主要结局
Wong-Baker FACES Pain Rating Scale
时间窗: Through study completion, an average of 1 year
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
次要结局
未报告次要终点
研究者
Selda Ateş Beşirik
Principal Investigator
Burdur Mehmet Akif Ersoy University