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临床试验/NCT05588687
NCT05588687已完成不适用

The Effect of Two Different Distraction Methods Applied During Venous Blood Collection Procedure on the Level of Pain, Fear and Anxiety in Pediatric Emergency Department

Trakya University2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2022年2月1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
159
试验地点
2
主要终点
Procedure Related Fear

研究概览

简要总结

The aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children.

详细描述

Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and pain. In cases where children's pain and fear cannot be controlled, health professionals and parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce pain and anxiety in children during painful procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. There are many methods used to divert attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to music, kaleidoscope, and using distraction cards. The research is a randomized controlled experimental study designed to determine the effects of two different methods (watching 360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during the blood collection procedure in children, on the level of pain, fear, and anxiety experienced by children.

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

入选标准

  • The child and family agree to participate in the research,
  • The child is between the ages of 5-12
  • The child does not have a chronic and mental health problem.
  • Not having a visual and hearing disability
  • No history of sedative, analgesic or narcotic substance use within 24 hours before admission
  • Not having a febrile illness at the time of application
  • Absence of a disease causing chronic pain
  • Being treated in the green area according to the 3-level (red-yellow-green) triage system.
  • Performing the operation at once

排除标准

  • • The child and family's refusal to participate in the research
  • Having a visual and auditory problem
  • The child is less than 5 years old or older than 12 years old
  • The child has a chronic and mental health problem
  • Being treated in the red or yellow area according to the 3-level (red-yellow-green) triage system.

结局指标

主要结局

Procedure Related Fear

时间窗: 1 minute after the blood draw procedure

The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.

Pain assesed by Wong-Baker FACES

时间窗: 1 minute after the blood draw procedure

Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.

Procedure Related Anxiety

时间窗: 1 minute after the blood draw procedure

The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber \& Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.

次要结局

未报告次要终点

研究者

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

Remziye Semerci

Assistant Professor

Trakya University

研究点 (2)

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