Nano-X: Patient Experience and Acceptance of Horizontal Rotation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System
研究概览
简要总结
Patients will complete validated psychometric questionnaires to quantify their experience of being rotated at different speeds using the Nano-X patient rotation system.
详细描述
Study participants will be asked to attend the clinic on two separate occasions. Each session will last less than one hour. Patients will be asked to complete validated psychometric surveys assessing 1) their level of claustrophobia, 2) their level of anxiety and 3) their (baseline) motion sickness, before and after each session. They will then be rotated 3-4 times on the Nano-X patient rotation system, at varying speeds ranging from 6°/sec to 45°/sec. Each rotation will be designed to simulate a typical radiotherapy treatment; that is 9 angles, pausing for around 30 seconds at each angle. Straight after each rotation, patients will again complete the questionnaire assessing their anxiety levels and motion sickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of cancer, any stage
- •≥18 years of age
- •Eastern Cooperative Oncology Group (ECOG) status 0-2
- •Currently or previously being treated with radiotherapy
- •Any prior therapy allowed
- •Willing and able to comply with all study requirements
- •Must be able to read and complete questionnaires in English
- •Signed, written informed consent
排除标准
- •Pregnant women
- •Mentally impaired patients or patients for whom attaining informed consent would be difficult (including language barriers)
- •Severe vertigo or recent diagnosis of Benign Paroxysmal Positioning Vertigo
研究组 & 干预措施
Patient rotation
Patients will be rotated horizontally, using the Nano-X patient rotation system, and asked to complete validated questionnaires to quantify their experience.
干预措施: Nano-X patient rotation (Device)
结局指标
主要结局
Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System
时间窗: 1 hour
Comparison of mean scores of Fast Motion Sickness Test (FMS) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation
Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System
时间窗: 1 year
Correlation between Claustrophobia Questionnaire (CLQ) scores prior to study participation on the anxiety and motion sickness results measured in Outcome 1 and Outcome 2
Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System
时间窗: 1 hour
Comparison of mean scores of Short Form State/Trait Anxiety Inventory (STAI) Questionnaire outcomes before and after being rotated in the Nano-X Patient Rotation System
次要结局
未报告次要终点