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临床试验/NCT05690230
NCT05690230已完成不适用

Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月5日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Virtual reality (Other)

Control 1

No Intervention

Standard of care without change, in parallel with intervention 1: Virtual reality.

Control 2

No Intervention

Standard of care without change, in parallel with intervention 2: Environmental changes.

Intervention 2: Environmental changes

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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