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临床试验/NCT04772430
NCT04772430Unknown不适用

Zonguldak Bulent Ecevit University

Zonguldak Bulent Ecevit University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale

研究概览

简要总结

The aim of this research is to determine the effect of the snow globe, which is used as a method of diverting attention, to the perception of pain that develops during the application of vaccines in infants between 2-6 months of age.

详细描述

Atraumatic care philosophy developed by Donna Wong; it is a principle of therapeutic care aimed at minimizing or eliminating the physical and psychological problems experienced by the child and his/her family. Pediatric nurse; it is obliged to offer atraumatic care by ensuring the cooperation of the child and his/her family, reducing pain and controlling stressors.

In accordance with the principles of atraumatic care; limitation of painful initiatives to prevent or reduce physical stress sources, regulation of environmental conditions, use of pharmacological and nonpharmamological pain removal methods in the presence of pain; promoting family-centered care in order to ensure the unity of children and family members; informing the child and his family about care to ensure the development of a sense of control, resting recommendations on care, establishing a daily care program.

The American Pain Association considers pain the fifth life finding. Studies show that all babies, including preterm babies, suffer pain and can distinguish pain from other sensory experiences. Controlling pain in children is multidisciplinary team work. It makes the nurse different from other team members in the control of pain and ensures that she is in an indispensable position; the nurse spends a long time with children, learns about the child's previous pain experiences and methods of coping with pain and benefits from coping methods when necessary, teaching the child and his family strategies to cope with pain, guiding them, applying planned treatment, monitoring their effects, results and empathizing, in short, being able to practice the nursing process.

Children who are often subjected to painful invasive interventions from the newborn period; however, they have a structure that requires the consideration of their level of development, cognitive and communicative skills, previous experiences of pain. According to the American Academy of Pediatrics , newborns and children are exposed to a total of 24 injections due to vaccination in the first 2 years of their life. In Turkey, the total number of injections for routine vaccination of children up to 2 years of age is 18. The negative effects of pain, which cannot be managed effectively, in physiological and psychological dimensions can occur even years later. The pain and stress experienced with deterioration in the clinical condition of newborns brings many complications.

Pain in children is more difficult to assess than in adults. The perception of pain in children, age, gender, family reactions to pain, previous experiences, insomnia, fatigue, fear, sadness, anger, being in an unpleasant environment can affect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Being registered at Bartın Family Health Center
  • Being in the age range of 2-6 months
  • Having parental consent
  • Does not have a congenital or chronic health problem,
  • Not taking an analgesic drug in the last 4 hours,
  • Infants of families who have accepted to participate in the study and signed the informed consent form will be included in the study

排除标准

  • Being aged between 0-1 months and over 6 months,
  • No parental consent,
  • Using analgesics in the last 4 hours,
  • The child has a congenital or chronic health problem

结局指标

主要结局

Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale

时间窗: 2-6 months

Flacc pain scale score is obtained by evaluating in five categories as facial expression, leg movements, activity, crying and consolingness. By giving 0, 1, or 2 points for each category, the total score between 0 and 10 is reached. As the pain intensity increases, the total score increases, as the pain intensity decreases, the total score decreases

次要结局

  • Heart rate(2-6 months)
  • oxygen saturation(2-6 months)
  • crying duration of babies(2-6 months)

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betul Akkoc

Zonguldak Bulent Ecevit University

Zonguldak Bulent Ecevit University

研究点 (2)

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