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临床试验/NCT06192498
NCT06192498已完成不适用

Comparison of the Effectiveness of Virtual Reality Glasses, Kaleidoscope and Distraction Cards in Reducing Pain and Anxiety During Blood Draw in Children: A Randomized Controlled Study

Burdur Mehmet Akif Ersoy University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
1
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 distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.

详细描述

n 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 compare the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.

This study is a prospective, randomized and controlled trial. Children aged 7 to 11 years who required blood draw were divided into three groups; Virtual Reality Glasses, Kaleidoscope, Distraction Cards 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 self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale.

The study population consisted of children aged 7 to 11 years who presented to the children's blood draw room of the hospital.

Sample of the study consisted of a total of 400 children who met the sample selection criteria and were selected via randomization method.

Children were randomized into three groups: Virtual Reality Glasses group (n= 100), Kaleidoscope group (n= 100), Distraction Cards group (n= 100) and Control group (n= 100).

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
None

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the ages of 7-11,
  • Volunteering of the child and parent to participate in the study,
  • Blood draw for routine control purposes,
  • Blood draw should be done by the same nurse,
  • The needle on which blood draw will be performed must be of the same thickness.

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 the application 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 painful procedure completion, an average of 10 minutes

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.

Children's Fear Scale

时间窗: Through painful procedure completion, an average of 10 minutes

CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).

次要结局

未报告次要终点

研究者

发起方
Burdur Mehmet Akif Ersoy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Ateş Beşirik

Principal Investigator

Burdur Mehmet Akif Ersoy University

研究点 (1)

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