Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Distress score
研究概览
简要总结
This study seeks to determine if patients undergoing a bone marrow biopsy/aspiration (BMBA) procedure who receive distraction techniques have lower levels of distress and pain, and higher post-procedure satisfaction, compared to those receiving standard-of-care. Intervention 1 is guided meditation in a virtual reality (VR) headset. Intervention 2 is comprised of environmental changes to the room (via nature-themed decals) and music.
详细描述
This study seeks to determine if patients undergoing a bone marrow biopsy/aspiration (BMBA) procedure who receive distraction techniques have lower levels of distress and pain, and higher post-procedure satisfaction, compared to those receiving standard-of-care. Intervention 1 is guided meditation in a virtual reality (VR) headset. Intervention 2 is comprised of environmental changes to the room (via nature-themed decals) and music.
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
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures
- •Over 18 years of age
- •Prior history of at least 1 (one) BMBA at Jefferson outpatient oncology office within the past 2 (two) years
- •Visiting the Jefferson outpatient oncology office for a BMBA procedure during the study duration
排除标准
- •Inability to read questions in English
- •Inability to answer questions autonomously
- •History of vertigo
- •Legal blindness in both eyes
- •Severe or profound hearing loss, or deafness
研究组 & 干预措施
Intervention 1: Virtual reality
干预措施: Virtual reality (Other)
Control 1
Standard of care without change, in parallel with intervention 1: Virtual reality.
Control 2
Standard of care without change, in parallel with intervention 2: Environmental changes.
Intervention 2: Environmental changes
干预措施: Environmental changes (Other)
结局指标
主要结局
Distress score
时间窗: Within 10 minutes post-procedure
The primary outcome will be reported on a scale of 0-10, based on the National Comprehensive Cancer Network (NCCN) Distress Thermometer, 0 signifying "no distress" and 10 signifying "extreme distress." This scale is standardly used with oncology patients to determine their distress levels-distress refers to "an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment."
次要结局
- Patient satisfaction(Within 10 minutes post-procedure)
- Pain intensity(Within 10 minutes post-procedure)
