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临床试验/NCT03913897
NCT03913897已完成不适用

Adiyaman University

Adiyaman University Research Hospital2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2018年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
2
主要终点
Children Fear Scale

研究概览

简要总结

Aim: The study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection.

Methods: The population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in Turkey between July and December 2018. A total of 139 children were included in the study, 46 of them with virtual reality goggles and 43 of them with control group. Information Form, Child Anxiety Scale, Visual Analogue Scale and Wong Baker Pain Scale were used in the collection of data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • being aged between 4 and 10 years for the child,
  • applying for health control purpose,
  • not having any chronic, mental or neurological illness,
  • not using any analgesic in the last 6 hours before the venipuncture procedure.

排除标准

  • having a chronic, mental or neurological illness,

研究组 & 干预措施

virtual reality group

Experimental

The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.

干预措施: distraction methods (Other)

kaleidoscope group

Experimental

The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.

干预措施: distraction methods (Other)

control group

No Intervention

No intervention was made to children in the control group

结局指标

主要结局

Children Fear Scale

时间窗: 1 minute

The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated

次要结局

  • Wong Baker Face Pain Scale(1 minute)
  • Visual Analogue Scale(1 minute)

研究者

发起方
Adiyaman University Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuba Koc Ozkan

Principal Investigator

Adiyaman University Research Hospital

研究点 (2)

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