The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Respiratory Rate
研究概览
简要总结
Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.
Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.
Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.
详细描述
The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial ABSTRACT Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.
Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.
Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.
Key words: allergy skin test, children, pain, anxiety, itching, virtual reality glasses, music.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 9-12 undergoing their initial skin test
- •With no cognitive, visual, or auditory impairments
- •No recent medical encounters involving pain or anxiety within the past 3 months
- •Parents who volunteered for participation in this study.
排除标准
- •Those who are not between the ages of 9 and 12 and have had a skin prick test before
- •With cognitive, visual, or auditory impairments,
- •Recent medical encounters involving pain or anxiety within the past 3 months,
- •Parents who volunteered no for participation in this study.
结局指标
主要结局
Respiratory Rate
时间窗: 12 weeks
Respiratory Rate ( one minute ) (/minute). Between 16-22 / minute
Pain Levels
时间窗: 12 week
Wong-Baker Faces Pain Rating Scale (a score of "0" to excruciating pain a value of "10")
Anxiety level
时间窗: 12 week
State-Trait Anxiety Inventory for Children (minimum score of 20 and a maximum score of 60)
Itching level
时间窗: 12 week
Visual Analogue Score ( rate the severity of the itch on a scale of one to ten) maximum 10axsimum 10
Heart Rate
时间窗: 12 weeks
Heart Rate ( pulse rate 70-110 ) ( /minute ) In the 9-12 age range, the lower pulse value is 70 and the upper value is 110.
Oxygen Saturation
时间窗: 12 week
Oxygen Saturation. ( between % 95-100)
次要结局
未报告次要终点
研究者
EDA UNAL
principal investigator
Uludag University