跳至主要内容
临床试验/NCT06443437
NCT06443437招募中不适用

Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy Among Preschool Children: A Randomized Controlled Study

Assiut University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
2
主要终点
child pain

研究概览

简要总结

Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. In this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. In the literature, there are studies with cold application, vibrating devices and a marionette doll in bee appearance therefor this study is aimed to evaluate the effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy among preschool children.

详细描述

Pain is one of the negative experiences faced in pediatric patients due to various medical interventions and often causes fear and anxiety. Pain perception is affected by the child's age, cognitive development, communication skills, previous pain experiences, and pain beliefs. Severe and long-term pain resulting from interventions can cause behavioral and physiological problems. In this period, if the pain is not alleviated or eliminated with appropriate interventions, it may cause neurological and behavioral disorders in the future. Nurses are responsible for minimizing the pain felt by children exposed to painful interventions and helping them cope with it .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children and parents who agreed to participate in the study
  • children had successful phlebotomy in the first attempt.

排除标准

  • Children who are having a chronic disease
  • Mental disability or mental retardation
  • Taking analgesics in the last 24 hours
  • Undergone a surgical procedure,
  • Not having a successful phlebotomy on the first attempt,
  • The child and his/her family not being willing to participate in the study.

结局指标

主要结局

child pain

时间窗: during phlebotomy

Facial expression rating scale (Wong-Baker Faces Pain Rating Scale). The Facial Expression Rating Scale includes 6 facial expressions and is a scale that provides a rating between 0 and 10 (Conlon, 2009; Huguet et al., 2010). Facial expressions range from"0" a smiling "brutal" face, 1-2 "It hurts a little", 3-4 "It hurts a little more", 5-6 "It hurts even more", 7-8 "It hurts a lot", and 9-10 "It hurts worst". This scale does not require words or numerical values and is a reliable and valid measurement tool in the assessment of acute pain. With this scale, the child's pain will be evaluated and recorded by both the nurse who will perform the phlebotomy and the parent.

次要结局

  • child fear(during phlebotomy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Hassan Khalf allah

lecturer

Assiut University

研究点 (2)

Loading locations...

相似试验

Effect of Bee-buzzy Vibrating Cold Application and... | 临床试验