VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Rate of sedation use calculated using number of treatment sessions
研究概览
简要总结
This phase I pilot trial studies how well video distraction works to decrease the use of sedation in pediatric participants during radiation therapy. Radiation treatment requires participants to lie very still (for accuracy). Many children cannot do this without sedation. Watching movies during radiation may distract children so they don't need sedation to complete treatment.
详细描述
PRIMARY OBJECTIVE:
I. To determine if the use of video distraction during radiation therapy (VidRT) during radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients previously treated without VidRT.
SECONDARY OBJECTIVE:
I. To determine which variables are associated with decreased need for sedation use. Variables will include patient age, length of treatment time (number of treatments and beam-on time), oncologic diagnosis, use of immobilization devices, pre-existing developmental or psychiatric diagnoses (attention deficit hyperactivity disorder [ADHD], dissociative disorders [DD], anxiety, depression, developmental delay, learning disability), pain scale ratings at time of first radiation treatment (0-10).
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All races and genders will be included.
- •Patients with all tumor types will be included.
排除标准
- •Patients < 3 years and > 13 years of age will be excluded.
- •Patients with underlying movement disorders will be excluded.
研究组 & 干预措施
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
干预措施: Questionnaire Administration (Other)
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
干预措施: Radiation Therapy (Radiation)
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
干预措施: Video (Other)
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Rate of sedation use calculated using number of treatment sessions
时间窗: Up to 1 year
A 1-sided binomial test will be used.
次要结局
- Number of treatments and association with decreased sedation use(Up to 1 year)
- Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use(Up to 1 year)
- Oncologic diagnosis and association with decreased sedation use(Up to 1 year)
- Use of immobilization device and association with decreased sedation use(Up to 1 year)
- Patient age and association with decreased sedation use(Up to 1 year)
- Beam "on-time" and association with decreased sedation use(Up to 1 year)
- Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten)(Up to 1 year)
研究者
Jerry Jaboin
Principal Investigator
OHSU Knight Cancer Institute