The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale Pain Scores Immediately Post-biopsy
研究概览
简要总结
The purpose of this research study is to see if a virtual reality (VR) headset is useful in reducing physical discomfort and anxiety experienced by patients who are scheduled to undergo a bone marrow biopsy (BMB) and/or bone marrow aspiration (BMA).
详细描述
This will be a randomized controlled trial comparing standard of care to standard of care + VR intervention for adult participants who have or are suspected of having a malignant hematologic disorder and are scheduled for an outpatient bone marrow biopsy (BMB) and/or bone marrow aspiration (BMA). Participants will be randomized 1:1. Participants will be risk stratified based on whether they are undergoing a biopsy for the first time or not.
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
- •Ability to understand and willingness to sign an IRB-approved informed consent directly.
- •Must be 18 years or older at time of consent.
- •Scheduled for an outpatient bone marrow biopsy (BMB) and/or bone marrow aspiration (BMA). Note that this does not need to be the participant's first BMB/BMA.
- •Participant should be suspected of or being diagnosed with a malignant hematologic disease (i.e., Acute or chronic leukemia, lymphoma, clonal plasma cell disorder, etc.) per the investigator.
- •Ability to read and understand the English language.
- •As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
排除标准
- •Participant is prescribed analgesics or anxiolytics for the purpose of reducing pain or anxiety prior to the procedure.
- •Participant with known intolerance to using virtual reality devices, significant motion sickness, history of seizures, history of vestibular disorders, or heart conditions (unstable angina, recent myocardial infarction within the last 3 months, decompensated heart failure, uncontrolled arrhythmias-ventricular tachycardia, a fibrillation with rapid ventricular rate), history of postural orthostatic tachycardia syndrome (POTS) per participant report.
- •Participants with pacemakers, defibrillators, hearing aid, or other implanted medical device. The Meta Quest device contains magnets and components that emit magnetic/electromagnetic fields which could affect the operation of nearby electronics and medical devices.
- •Planned to undergo the bone marrow biopsy/bone marrow aspiration via Interventional Radiology or as an inpatient admission.
研究组 & 干预措施
Standard of Care
干预措施: Standard of Care (Other)
Virtual Reality intervention and Standard of Care
干预措施: Standard of Care (Other)
Virtual Reality intervention and Standard of Care
干预措施: Virtual Reality intervention (Other)
结局指标
主要结局
Numeric Rating Scale Pain Scores Immediately Post-biopsy
时间窗: Single time point evaluation completed immediately following biopsy procedure
For each participant, the Numeric Rating Scale (NRS) score immediately post-biopsy will be captured indicating the participants' severity of pain. The score for each participant will be categorized into 6 ordinal categories (0 No Pain, 1-2 Very Mild, 3-4 Mild, 5-6 Moderate, 7-8 Severe, 9-10 Unbearable) and used to assess if those using the Virtual Reality Headset during the procedure experienced less overall pain immediately following the bone marrow biopsy.
Numeric Rating Scale Pain Scores Immediately Post-biopsy
时间窗: Single time point evaluation completed immediately following biopsy procedure
For each participant, the Numeric Rating Scale (NRS) score immediately post-biopsy will be captured indicating the participants' severity of pain. The score for each participant will be categorized into 6 ordinal categories (0 No Pain, 1-2 Very Mild, 3-4 Mild, 5-6 Moderate, 7-8 Severe, 9-10 Unbearable) and used to assess if those using the Virtual Reality Headset during the procedure experienced less overall pain immediately following the bone marrow biopsy.
次要结局
- Single time point evaluation completed immediately following biopsy procedure(Single time point evaluation completed 24 hours after biopsy procedure.)
- State Trait Anxiety Inventory Trait-5 Change Score(Two time point evaluations completed immediately following and 24 hours after biopsy procedure.)
- Likelihood to Repeat(Single time point evaluation completed 24 hours after biopsy procedure.)
- Single time point evaluation completed immediately following biopsy procedure(Single time point evaluation completed 24 hours after biopsy procedure.)
- Likelihood to Repeat(Single time point evaluation completed 24 hours after biopsy procedure.)
- State Trait Anxiety Inventory Trait-5 Change Score(Two time point evaluations completed immediately following and 24 hours after biopsy procedure.)