RADIOACTIVE - Radiotherapy Patient Education With Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
The purpose of this research study is to investigate the impact of virtual reality experiences on individuals undergoing radiotherapy, aiming to assess whether this immersive technology can reduce anxiety and enhance patient overall treatment satisfaction. By comparing different virtual reality techniques and a standard informational video, the study seeks to identify optimal strategies for leveraging virtual reality to improve the patient experience during radiotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven cancer
- •≥18 years of age
- •Able to speak and read English and/or Spanish
- •Receiving radiotherapy at the University of Miami
排除标准
- •Prior radiation therapy
- •Pregnant or nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •Patients unable to consent or are prisoners
- •Participants with impaired decision-making capacity
- •Any serious illness or medical condition that would compromise patient safety during virtual reality as judged by the treating physician
- •Unwilling or unable to watch virtual reality video
- •Unwilling to fill out survey forms
结局指标
主要结局
Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)
时间窗: Baseline, up to 2 weeks
The State-Trait Anxiety Inventory (STAI) is a brief and widely used self-assessment tool validated to measure anxiety in individuals undergoing medical therapy or other stressful experiences. The scale consists of 20 items, with separate scales for trait and state. Scores on the Likert scale, ranging from 0 to 4, provide an assessment of symptom severity in patients dealing with various medical conditions (state) as well as baseline status (trait). Higher scores indicate higher levels of anxiety.
次要结局
- Change in Radiation Oncology Knowledge Assessment Survey (ROKAS)(baseline, up to 1 day (after intervention))
- Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI)(Baseline, up to 8 weeks)
- Change in Health-Related Quality of Life measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire(Baseline, up to 8 weeks)
研究者
Benjamin Rich
Assistant Professor of Clinical
University of Miami