User Evaluation New Ambient Experience Content
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 12
- 主要终点
- Child anxiety level
研究概览
简要总结
The study aims to investigate the effect of Philips Ambient Experience with specially designed paediatric content on the experience of pediatric patients undergoing an MRI examination, their caregiver, and clinical staff, on workflow and on clinical outcome. The designed paediatric content exists of personal selection of a character, video projection on the wall and/or a screen visible when in the bore, audio, and room ambience lighting.
The study will be conducted in collaboration with six partner hospitals within the EU. At each hospital, 50 pediatric patients between 6 and 12 years old will be included in the study.
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
- 否
入选标准
- •Patients between 6 and 12 years old
- •Scheduled for a head-first MRI scan
- •Parent/guardian and child speak and read the local language.
- •Positive judgement by on-site PI/(co-) investigator for awake scanning
排除标准
- •General anesthesia
- •Clinically diagnosed cognitive, or developmental disorder (e.g. ADHD, ASD) or neurological problems that prevent the ability to lie/hold still for an MRI scan while awake
- •Previous MRI examination with Philips Ambient Experience
结局指标
主要结局
Child anxiety level
时间窗: The visit on the imaging department; before and during the examination. This is estimated to be 10 up to 30 minutes, depending on the MRI scans that have to be made.
Change of anxiety level of child measured with an observational scale by staff or (co-) investigator before and during the scan. By using a modified yale preoperative anxiety scale, with a range from 22.92 to 100; higher values indicating greater anxiety.
次要结局
- Immersiveness and engagement with Ambient Experience and content(After the scan, 5 minutes.)
- Parent/ Guardian satisfaction(After the scan, 5 minutes)