NCT07004803已完成不适用
The Effect of Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency Applying Intravenous Immunoglobulin During Intravenous Access: A Crossover Randomized Controlled Trial
Dr. Hatice Dönmez1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年9月15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
- 31
- 试验地点
- 1
- 主要终点
- Children's Fear Scale
研究概览
简要总结
In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 4-11
- •Being followed up with the diagnosis of Primary Immunodeficiency for at least 6 months
- •To accept participation in the study voluntarily
- •No additional chronic disease other than primary immunodeficiency
排除标准
- •Organ failure is present
- •Having a mental deficiency
- •Having a disability to use VR Glasses
- •Children with fever (|>37.5 C0)
- •Children with severe dehydration
研究组 & 干预措施
Virtual reality group
Experimental
干预措施: Virtual reality video watching (Other)
Tablet group
Active Comparator
干预措施: Tablet video watching (Other)
结局指标
主要结局
Children's Fear Scale
时间窗: 5 minutes
Wong-Baker Pain Scale
时间窗: 5 minutes
Children's Emotional Manifestation Scale
时间窗: 5 minutes
次要结局
- Vital Signs(5 minutes)
研究者
Dr. Hatice Dönmez
Assistant professor
Karamanoğlu Mehmetbey University
研究点 (1)
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