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临床试验/NCT05012904
NCT05012904已完成不适用

Using Parental Involvement During Venipuncture to Reduce Venipuncture Pain and Anxiety in Children With Cancer: A Randomized 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6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

This study aims to determine whether parental involvement during venipuncture reduces venipuncture pain and anxiety in children with cancer.

详细描述

This was a randomized controlled trial with parallel groups in which 60 children with cancer aged 6-12 were randomly allocated to a control group (n = 30) and a parent involvement group (n = 30). Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during venipuncture, and each child's pain during the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during the procedure.

Control group (n = 30): Routine venipuncture procedure was applied to the control group. The parent was present in the child's room but did not participate in the procedure.

Parent involvement group (n = 30): A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in the procedure.

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

  • •diagnosed with cancer,
  • •requiring venipuncture for blood tests,
  • •6-12 years old,
  • •not having taken any analgesics in the 6 hours before venipuncture,
  • •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

  • •reporting pain for another reason in the time of the venipuncture
  • •having another chronic disease besides cancer

研究组 & 干预措施

Parent involvement Group

Experimental

A parent was involved in the procedure. The parent held the children in their arms and holding the extremity from which the blood was drawn, holding the hands of children and communicating with their children in the child's room, and in this way the parent was involved in the procedure.

干预措施: parent involvement application (Behavioral)

Control Group

No Intervention

Routine venipuncture procedure was applied to the control group. The parent was present in the child's room but did not participate in the procedure.

结局指标

主要结局

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

时间窗: 3 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).

次要结局

  • Children's Fear Scale (CFS)(3 MONTHS)
  • Heart Rate(3 MONTHS)
  • Oxygen Saturation(3 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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