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临床试验/NCT05974319
NCT05974319已完成不适用

The Effect of Dry Heat and Dry Cold Application on Pain, Anxiety and Fear Levels Before Blood Sample Collection in School Age Children: A Randomized Controlled Study

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Wong Baker Faces Pain Rating Scale

研究概览

简要总结

The study was conducted as a parallel group randomized controlled in order to determine the effects of dry heat and dry cold application before blood collection in school-aged children (7-12 years old) on pain, anxiety and fear levels.

Participants were randomly assigned to experiment 1-dry hot application group, experiment 2-dry cold application group and control group.

In Experiment 1-Dry Heat Application group, a dry heat of 42°C was applied to the determined area with an electrical heating pad for 5 minutes before blood sample was taken.

In Experiment 2-Dry Cold Application group, dry cold was applied to the area determined with a gel pad for 3 minutes before blood sample was taken.

In the Control group, blood sampling was performed according to the clinical routine, and no heat or cold application was made.

详细描述

Prior to blood sampling, parents and children were initially informed about the study in Experiment 1-dry heat, Experiment 2-dry cold, and control groups, and their written and verbal consents were obtained. After obtaining consent, information about the child and family was collected by the researcher with the "Child-Family Introductory Information Form" before the procedure. After the family and the child were introduced to the measurement tools (Wong Baker Faces Pain Scale, Child Fair Anxiety Scale and Medical Procedures Fear Inventory) to be scored, it was explained to the child that his mother or father would be with him during the procedure, and he was taken to the intervention room. Before the blood sample collection, the child's fear and anxiety were evaluated using Child Fear Anxiety Scale.

In Experiment 1-Dry Heat Application group, the electrical heating pad with temperature regulation was heated by the researcher and set to 42°C. After making sure that there were no contraindications (deterioration of skin integrity, etc.) in the application of the electrical heating pad device, a dry heat of 42°C was applied to the determined area with an electrical heating pad for 5 minutes.

In Experiment 2-Dry Cold Application group, dry cold was applied to the determined area with a gel pad for 3 minutes after the researcher made sure that there were no contraindications (deterioration of skin integrity, etc.) in the application of the gel pad.

In the Control group, blood sampling was performed according to the clinical routine, and no heat or cold application was made.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 7-12 years old
  • Absence of physical and mental illness
  • Absence of auditory, visual and verbal speech disability
  • Parents' willingness to participate in the research, and signing the volunteer form

排除标准

  • Those who do not meet the inclusion criteria
  • Those who do not volunteer to participate

结局指标

主要结局

Wong Baker Faces Pain Rating Scale

时间窗: One minutes after blood sampling; once

Refers to the pain felt due to the blood sample collection process.

次要结局

  • Child Anxiety Scale(Two minutes before blood sampling, two minutes after blood sampling; twice.)
  • Child Fear Scale(Two minutes before blood sampling, Two minutes after blood sampling; twice.)
  • Medical Procedures Fear Inventory(Three minutes after blood sampling; once.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Eren Fidancı

Associate professor

Saglik Bilimleri Universitesi

研究点 (2)

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