The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures
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
- Subjective Pain Assessment: Visual Analog Scale
研究概览
简要总结
To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.
详细描述
Breast biopsies for patients with abnormal mammograms are required to identify cancerous tissue. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding potentially having cancer and the possibility of cancer-related procedures. Different types of biopsies may have different pain and anxiety based on their duration and complexity. This research is designed to determine if VR simulated environment can reduce pain and anxiety.
The aim is to study the efficacy of a virtual environment in reducing pain and procedural anxiety. It is intended for patients undergoing an ultrasound guided breast biopsy procedure that have had an abnormal mammogram. The overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent is obtained from the patient
- •Females who are 18 years of age
- •Patient is scheduled for preoperative ultrasound guided breast biopsy procedure
排除标准
- •Patient is scheduled for a stereotactic biopsy procedure
- •The patient has motion sickness
- •The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English
- •The patient has a history of seizures or epilepsy
- •Refusal of patient to sign consent
结局指标
主要结局
Subjective Pain Assessment: Visual Analog Scale
时间窗: Immediate post-procedure
Pain Measured with the Visual Analog Scale. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The individual will score their pain level by circling a number 0 - 10 both pre-operative and post-operatively. The scale range includes 0-10 scales, with \< 2 =well controlled, 2 - 5: partly controlled, \> 5: uncontrolled.
次要结局
- State-Trait Anxiety Inventory (STAI: Y-6 item)(Immediate post-procedure)
- Patient Satisfaction(Immediate post-procedure)