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临床试验/NCT06246877
NCT06246877尚未招募不适用

Effect of Virtual Reality on Pain and Fear Level During Kirschner Wires (K-Wires) Removal and Dressing in Children

Ondokuz Mayıs University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
2
主要终点
Wong-Baker Faces Pain Scale

研究概览

简要总结

This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.

详细描述

Technology-based methods have now begun to be used to control anxiety and prevent pain that may occur before, during and after diagnosis and treatment procedures in children.

Virtual reality (VR), which is among the technological products, can be used in non-pharmacological methods as well as pharmacological methods.

It has been observed that VR, especially in children, creates an analgesic effect by mainly distracting the pain centers in the brain and evokes positive emotions with an anxiolytic effect.Since children do not want to see the procedures to be performed on them, virtual reality used during the procedure is one of the methods of diverting attention from the environment they are in. This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.

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
Single (Participant)

入排标准

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

入选标准

  • •Being a child between the ages of 7-12 who will have the K wire removed
  • •The child is not using glasses
  • •The child must be at a cognitive development level that can respond to video selection.

排除标准

  • •Having a disease that causes chronic pain
  • •The child must have used medication that would have an analgesic effect in the last 24 hours before the application.
  • •The child is wearing glasses
  • •The child has a mental or neurological disability

研究组 & 干预措施

virtual reality applied group

Experimental

Before the K-wire is removed and dressed, the three-dimensional video that the child likes and wants to watch will be placed on virtual reality glasses and attached to the child.

During the procedure, the child will be allowed to watch videos through virtual reality glasses.

干预措施: virtual reality applied group (Behavioral)

control group

No Intervention

During the removal and dressing of the wire, the child's attention will be diverted by asking some questions (where she lives, the name of the school she attends, what grade she attends, etc.).

结局指标

主要结局

Wong-Baker Faces Pain Scale

时间窗: The "Wong-Baker Faces Pain Scale" will be scored 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Wong-Baker Faces Pain Scale" 5 minutes after the K-wire removal and dressing.

It is suitable for ages three and above. The pain level of the faces on the scale is explained to the child: "Face 0" indicates that there is no pain and is very happy. "Face 2" has some pain. "Face 4" has slightly more pain. "Face 6" has more pain. The pain of "Face 8" is quite severe. The pain of "Face 10" is unbearable.

次要结局

  • Children's Fear Scale("Child Fear Scale" scoring will be done 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Child Fear Scale" 5 minutes after the K-wire removal and dressing.)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra TURAL BUYUK

Assoc Prof

Ondokuz Mayıs University

研究点 (2)

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