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临床试验/NCT04924023
NCT04924023已完成不适用

The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes on Anxiety and Pain in Children With Cancer: A Randomised Controlled Study

Mehmet Akif Ersoy University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月1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
60
试验地点
1
主要终点
Wong-Baker FACES Pain Rating Scale (WB-FACES)

研究概览

简要总结

Many medical interventions, including the dressing of central venous catheters, a common procedure used for children with cancer, cause anxiety and pain in children. This can adversely affect their care and recovery. This study aims to determine the effect of using a kaleidoscope during central venous catheter dressing on anxiety and pain in children with cancer.

详细描述

This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's anxiety was evaluated by the child using the Child Fear Scale before, during and after a central venous catheter dressing procedure, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES). Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after central venous catheter dressing.

The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.

No intervention was performed to reduce pain and anxiety for children in the control group.

Parents accompanied their children during the procedure in both groups.

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
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •a cancer diagnosis,
  • •having a central venous catheter,
  • •6-12 years old,
  • •not having taken any analgesics in the 6 hours before the central venous catheter dressing, -being in a non-terminal phase of the disease,
  • •absence of neutropenia,
  • •volunteering to participate in the study,
  • •the absence of any health problems that prevent communication in the parent or the child.

排除标准

  • •the reporting of pain for another reason at the time of the central venous catheter dressing.

研究组 & 干预措施

Kaleidoscope Group

Experimental

Children in this group were told what a kaleidoscope is and how to use it before their central venous catheter dressing. The children were then asked if they would like to look into the kaleidoscope. The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished. The kaleidoscope was disinfected before each use. A kaleidoscope was provided for all children in this group by the same researcher. Parents accompanied their children during the catheter dressing.

干预措施: kaleidoscope application (Behavioral)

Control Group

No Intervention

No intervention was performed to reduce pain and anxiety for children in the control group. Parents accompanied their children during the procedure.

结局指标

主要结局

Wong-Baker FACES Pain Rating Scale (WB-FACES)

时间窗: 5 MONTHS

The Wong-Baker Faces Pain Rating Scale (WB-FACES) is used to evaluate pain levels in children. This numeric rating scale ranges from 0 to 10 and is represented by faces that display emotions ranging from smiling (0 = very happy or no pain) to crying (10 = the worst pain).

Children's Fear Scale (CFS)

时间窗: 5 MONTHS

The Children's Fear Scale (CFS) is used to evaluate anxiety levels in children. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).

次要结局

  • Heart Rate(5 MONTHS)
  • Oxygen Saturation(5 MONTHS)

研究者

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

Pınar BEKAR

Assistant Professor

Mehmet Akif Ersoy University

研究点 (1)

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