Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain as assessed according to a visual analog scale (VAS)
研究概览
简要总结
This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of VR in patients undergoing procedural intervention.
SECONDARY OBJECTIVES:
I. To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.
EXPLORATORY OBJECTIVES:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been diagnosed with any cancer
- •Patient is currently hospitalized and receiving treatment for a primary or secondary cancer at University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital
- •Patient is undergoing a bone marrow biopsy or lumbar puncture
排除标准
- •Inability to sign informed assent and/or consent
- •Patient with an underlying diagnosis of epilepsy, dementia, Parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated
- •Patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified
- •Patient with active Clostridium difficile infection
- •Patient on any acute (within last < 24 hour [hr]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug [NSAID], steroid)
- •Patient on chronic steroids > 10 mg prednisone equivalent daily or other immunosuppressant > 1 week
- •Patient who is post bone marrow transplant
- •Patient with a body mass index (BMI) > 35
研究组 & 干预措施
Arm II: No Virtual Reality
Participants receive standard of care during bone marrow biopsy or lumbar puncture.
干预措施: Best Practice (Other)
Arm I: Virtual Reality
Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I: Virtual Reality
Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure.
干预措施: Oculus Rift Headset (Device)
Arm I: Virtual Reality
Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure.
干预措施: Questionnaire Administration (Other)
Arm II: No Virtual Reality
Participants receive standard of care during bone marrow biopsy or lumbar puncture.
干预措施: Questionnaire Administration (Other)
Arm II: No Virtual Reality
Participants receive standard of care during bone marrow biopsy or lumbar puncture.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Pain as assessed according to a visual analog scale (VAS)
时间窗: Up to 1 year
A visual analogue pain scale is a validated pain measure. A 10 centimeter horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10.
Anxiety
时间窗: Up to 1 year
Will be assessed by the State-Trait Anxiety Inventory.
次要结局
未报告次要终点