NCT06862830进行中（未招募）不适用
The Effectiveness of Virtual Reality in the Management of Procedural Anxiety and Pain in Children Suffering from Chronic Pathologies or Burn Injuries. Single-center Randomized Controlled Trial.
Meyer Children's Hospital IRCCS1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年10月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Percentage reduction in anxiety score
研究概览
简要总结
Single-center, randomized, controlled clinical trial (RCT) to evaluate the efficacy of VR on pain and anxiety in children with chronic diseases undergoing painful procedures in an outpatient or day hospital setting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria: Inclusion
- •The study population includes children who meet the following criteria:
- •Diagnosis of a chronic condition, aged 3 to 18 years, without visual impairments or cognitive deficits, and with a confirmed diagnosis of the condition.
- •Children receiving care in the wound care nursing clinic or Medical Day Hospital (DH) who require minimally invasive painful procedures.
- •Assent and informed consent provided by both the children and their parents.
- •Children with chronic conditions that do not inherently cause chronic pain, which could alter pain perception (e.g., rheumatoid arthritis, diabetic foot, muscular dystrophy).
- •Children able to understand and communicate in Italian or English.
- •Parents able to understand and communicate in Italian or English. Eligibility Criteria: Exclusion
- •Children with the following characteristics will be excluded from the study:
- •Chronic condition not yet diagnosed.
- •Use of eyeglasses, presence of amblyopia or monocular vision.
- •Chronic pain, which could distort pain perception during the procedure.
- •Use of analgesic therapy within the last 8 hours, which could bias data collection results (the only prohibited therapy in the study and a reason for exclusion).
- •Cognitive impairment preventing the proper use of assessment scales.
排除标准
- 未提供
研究组 & 干预措施
Virtual reality video
Experimental
干预措施: Virtual reality video (Other)
Standard of care
No Intervention
结局指标
主要结局
Percentage reduction in anxiety score
时间窗: From recruitment to end of painful procedure
Effectiveness of VR in reducing pain and anxiety in children undergoing painful procedures (blood draw, intramuscular injection, and wound dressing).
Percentage reduction in pain
时间窗: From recruitment to end of painful procedure
次要结局
- Percentage of reduction in parental anxiety(From recruitment to end of painful procedure)
研究者
Biagio Nicolosi
Principal Investigator
Meyer Children's Hospital IRCCS
研究点 (1)
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