The Use of Virtual Reality During Breast Localization Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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 localization procedure (traditional wire, savi scout or a radiofrequency identification tag).
详细描述
Needle localizations for breast cancer surgery are required to identify cancerous tissue before surgery. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding cancer and cancer-related procedures. Different types of needle localization may have different pain and anxiety based on their duration, complexity, and invasiveness. This research is designed to determine if VR simulated environment can reduce pain and anxiety.
Our 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 localization procedure that have had an abnormal breast biopsy. 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 ≥ 18 years of age
- •Patient is schedule for preoperative ultrasound guided breast localization procedure
排除标准
- •Patient is scheduled for or switched to a stereotactic localization procedure
- •The patient has motion sickness
- •The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English
- •Refusal of patient to sign consent
研究组 & 干预措施
Virtual Reality Goggles
Patients randomized to the intervention group will undergo their procedure as standard of care but will wear the Oculus Go Goggles and experience a virtual reality simulation. The simulation is a non-interactive polar theme video.
干预措施: Oculus Go Virtual Reality Goggles (Device)
Control
Patients randomized to the control group will undergo their procedure as standard of care without the use of virtual reality goggles.
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 at baseline, 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)