A Game-Like Skin Testing Experience: The Effect of Virtual Reality (VR) on Skin Prick Test Related Pain and Fear in Children (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Skin prick test-related pain
研究概览
简要总结
This study aims to show the effect of VR on skin prick test-related pain and fear in children. The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR.
详细描述
Pain and fear during interventional procedures in pediatric patients are some of the most difficult problems in hospitals. While bad experiences in childhood can lead to increased sensitivity to pain, sleep problems, social learning difficulties, phobias, pre-treatment anxiety disorders, and treatment resistance; increases the risk of anxiety and depression in adulthood.
Skin prick test is the gold standard diagnostic method most frequently used in Pediatric Allergy clinics for the detection of allergens with high sensitivity, specificity, and reliability. The numerous pricking procedures performed during the skin test may turn into a painful and frightening experience for children.
Virtual reality (VR) is often accomplished using a special headset or glasses and can create for children a virtual world separate from their current physical environment, effectively distracting them from the possible pain and fear experience.
There is no study in the literature investigating the effect of VR on skin prick test-related pain and fear in children. This study aims to show the effect of VR on skin prick test-related pain and fear in children. The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR.
The hypotheses of this study were to:
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
- Single (Participant)
盲法说明
Children aged 4 to 10 years for whom a skin prick test has been decided.
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being between the ages of 4-10 years
- •requirement of skin prick test due to allergic diseases
排除标准
- •having chronic diseases (except allergic diseases)
- •vision, hearing, and speech disorders
- •psychiatric and neurological diseases
- •mental status disorder, learning and perception disorder
- •a history of pre-procedure sedative, analgesic or narcotic drug use within 24 hours
- •a history of active infection
- •those who are scheduled to undergo a skin test other than an aeroallergen panel
- •contra-indicated conditions for skin prick testing such as dermographism, severe eczema, being under drugs (immunosuppressive drugs, antihistamine, steroid, etc)
研究组 & 干预措施
Experimental: VR
Children in the VR group put on VR glasses for approximately two minutes before the skin prick test and watched a VR underwater experience video throughout the procedure.
干预措施: Virtual reality (VR) (Behavioral)
No Intervention: Control
Children in the control group underwent a routine skin prick test procedure. Control group children did not receive any distraction techniques.
结局指标
主要结局
Skin prick test-related pain
时间窗: Through painful procedure completion, an average of 10 minutes.
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. The Wong-Baker FACES Pain Rating Scale (WB-FACES) was developed in 1981 and revised in 1983. WB-FACES is a reliable scale that has been validated for the Turkish population. The scale is used to diagnose pain in children ages 3-18 years. It consists of six facial expressions, each representing increasing degree of pain scored from 0 to 10 from left to right (0 = very happy face/no pain, 10 = a crying face/worst pain imaginable). High scores indicate low pain tolerance. The child is asked to rate his/her pain by asking "Can you show me the face that shows how you feel right now?".
Skin prick test-related fear
时间窗: Through fearful procedure completion, an average of 10 minutes.
The Child Fear Scale (CFS) used. The Child Fear Scale (CFS) was developed in 2011. It was adapted into Turkish in 2018, by studying it with children aged 4-10 years. It consists of five facial expressions representing a range from neutral=0 to extreme fear=4.
次要结局
未报告次要终点
研究者
Cihangir Sahin
Research Assistant Medical Doctor
Aydin Adnan Menderes University