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临床试验/NCT04847934
NCT04847934已完成不适用

Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection in Pediatric Emergency Department

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Fear assesed by Child Fear Scale

研究概览

简要总结

Buzzy, shot-blocker, distraction cards, and balloon blowing can reduce fear and pain during the intramuscular intervention in the pediatric emergency service unit. This study aimed to evaluate the effect of virtual reality, manual pressure vibration technique, and cold vibration device application on procedure-related pain, fear, and anxiety during intramuscular antibiotics in children aged 5-12 years in the pediatric emergency department.

详细描述

Study Hypothesis The pain, fear, and anxiety scores of the children who watch videos with virtual reality glasses during the intramuscular intervention are lower than the other groups.

The pain, fear, and anxiety scores of children who were applied manual pressure vibration technique during the intramuscular intervention are lower than the other groups.

The pain, fear, and anxiety scores of the children who were applied cold vibration (Buzzy) during the intramuscular intervention were lower than the other groups.

The emotional appearance scores of the children in groups before the procedure affect the pain, fear, and anxiety they experience.

The group with children affects the vital signs before and after the distraction technique.

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
Double (Care Provider, Investigator)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children are between the ages of 5-12
  • Intramuscular antibiotics (penicillin, ceftriaxone, amikacin etc.) to be administered
  • The intervention will be applied from the gluteal region
  • The child agrees to voluntarily participate in the study.
  • Parents agree to voluntarily participate in the study
  • Obtaining consent form from the child and parent

排除标准

  • child with a physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
  • child with sedative or analgesic medication.
  • child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease

结局指标

主要结局

Fear assesed by Child Fear Scale

时间窗: procedure (during the ıntramuscular injection)

The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.

Pain assesed by Wong-Baker FACES

时间窗: procedure (during the ıntramuscular injection)

Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

Anxiety assesed by Children Anxiety Meter-State

时间窗: procedure (during the intramuscular injection)

The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety

次要结局

  • Emotional Appearance Scale for Children(Baseline (before the intramuscular injection))

研究者

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

Gülçin Özalp Gerçeker

Dokuz Eylul University

Dokuz Eylul University

研究点 (2)

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