AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 16
- 主要终点
- Success rate of AVATAR system
研究概览
简要总结
To determine the success rate of the AVATAR audio-visual system. All patients enrolled in the study will be counted, and each patient who is able to undergo at least one fraction without anesthesia will count as a success while each patient who does not have at least one fraction without anesthesia will count as a failure. The success rate will be the proportion of patients who are successes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.
- •The patient must speak English or Spanish.
排除标准
- •If parent/guardian is unable to take part in helping to complete questionnaires
- •Patients with malignancies of the eye for which radiation is planned
- •Patients that do not speak English or Spanish
研究组 & 干预措施
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy
干预措施: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (Device)
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy
干预措施: Quality of Life Survey, PedsQL3.0 (Other)
Audio-Visual Assisted Therapeutic Ambience in Radiotherapy
干预措施: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF) (Other)
结局指标
主要结局
Success rate of AVATAR system
时间窗: 24 months
Success rate will be determined as the proportion of patients who are successes. Success will be counted as each patient who is able to undergo at least one fraction without anesthesia while each patient who does not have at least one fraction without anesthesia will count as a failure.
次要结局
- Assess predictability for AVATAR patient success(24 months)
- Difference in health quality of life between subjects with or without anesthesia(24 months)
- Compare the rates of anesthesia with historical controls(24 months)
- Measure Fractional Success using AVATAR system(24 months)
- Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR(24 months)
- Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.(24 months)