跳至主要内容
临床试验/NCT06466551
NCT06466551已完成不适用

The Effect of Virtual Reality Goggles and Stress Ball Used During Intravenous Catheterization on Pain and Fear in Children: A Randomized Experimental Study

Toros University2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2024年6月15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
75
试验地点
2
主要终点
Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale

研究概览

简要总结

Although distraction methods such as virtual reality glasses, watching videos, watching cartoons, etc. have been reported to reduce pain in the literature, studies on which method is more effective in reducing pain are limited. Considering the developmental period characteristics, virtual reality glasses and stress ball squeezing may be effective in the 6-12 age group during painful intervention. However, no study has been found in the literature on which technique is more effective (9-23). Therefore, investigating the effects of virtual reality goggles and stress ball squeezing on pain and fear in children aged 6-12 years as a distraction method during intravenous catheterization may enable nurses to determine the technique with high clinical usefulness in pain management.

详细描述

Provide a brief summary of the study, including the purpose, objectives, and brief methodology.

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

入选标准

  • Children aged 6-12 years
  • Admitted to the pediatric unit of the hospital between June 20, 2024, and April 20, 2025
  • Scheduled to undergo intravenous catheterization
  • Having parental consent through a signed informed consent form
  • Absence of mental or developmental retardation

排除标准

  • Children for whom the first attempt at intravenous catheterization was unsuccessful

结局指标

主要结局

Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale

时间窗: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)

Pain scores will be measured using the Wong-Baker FACES Pain Rating Scale. Scores will be recorded before, during, and after intravenous catheterization. Pain will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Pain will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).

Change in Fear Scores Assessed by the Children's Fear Scale

时间窗: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)

Fear levels will be assessed using the Children's Fear Scale. Scores will be recorded before, during, and after intravenous catheterization. Fear will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Fear will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).

Change in Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale

时间窗: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)

Pain scores will be measured using the Wong-Baker FACES Pain Rating Scale. Scores will be recorded before, during, and after intravenous catheterization. Pain will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Pain will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).

Change in Fear Scores Assessed by the Children's Fear Scale

时间窗: Baseline (before the procedure), Mid-procedure (during the procedure), Post-procedure (immediately after the procedure)

Fear levels will be assessed using the Children's Fear Scale. Scores will be recorded before, during, and after intravenous catheterization. Fear will be assessed immediately before the procedure (baseline), during the procedure (mid-procedure), and immediately after the procedure (post-procedure). Fear will be evaluated independently by the child (self-report), parent (observational), and researcher (observational).

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

Didem Polat Kulcu

Assist. Prof. Dr.

Toros University

研究点 (2)

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