The Efficacy of Virtual Reality Experiences on Acute Pain and Distress Caused by Fluoroscopic Pain Intervention in Chronic Pain Patients - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 11-point scale pain score
研究概览
简要总结
The aim of this study is to evaluate the efficacy of virtual reality experiences on acute pain and distress caused by fluoroscopic pain intervention in chronic pain patient.
详细描述
The investigators perform lots of interventions for patients. But unfortunately, patients cannot help being exposed to the acute pain and fear during the interventions. "Virtual Reality(VR)" is a state-of-art advanced technology, which is now being extended to various medical fields such as pain management, dental treatment, body rehabilitation and cancer pain. There is no study that have conjugated the virtual reality experience for patients' acute pain and anxiety which occurs during the pain interventions. So the investigators like to evaluate the effects of virtual reality experience on acute pain and anxiety precipitated by the pain interventions.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If all of the following conditions are met :
- •Patient who has chronic pain lasting more than 3 months and whose pain doctor determined that he or she needs following fluoroscopic pain intervention : Lumbar sympathetic ganglion block (LSGB), Fluoroscopic-guided pulsed radiofrequency ablation (pRF), Fluoroscopic-guided radiofrequency thermocoagulation (hRF)
- •Adults who are at least 20 years of age
- •Patients whose American Society of Anesthesiologists(ASA) physical status is classified as 1 or
- •A person who voluntarily agrees to participate in this clinical trial and has agreed in informed consent.
排除标准
- •If the subject falls under any of the following conditions :
- •Patients who cannot have virtual reality experience due to hearing or visual impairment
- •If the patient has difficulty communicating due to lack of cognitive ability
- •Patients that examiners deemed unsuitable for this trial
结局指标
主要结局
11-point scale pain score
时间窗: 15min after the procedure
11-point scale pain score was assessed by the patient during the fluoroscopic-guided intervention, 0-10. 0 means no pain, 10 means the most severe pain one can imagine
次要结局
- Total amount of local anesthetics used to skin infiltration(intraoperative)
- Vital sign of the patient: Heart rate (beat per minute)(Intraoperative)
- Vital sign of the patient: electrocardiogram(ECG)(Intraoperative)
- Net Promotor Score (NPS) by physician(15min after the procedure)
- Hamilton Anxiety rating score (HAM-A)(15min after the procedure)
- Net Promotor Score (NPS) by patient(15min after the procedure)
- Total procedural time(intraoperative)
- Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)(Intraoperative)
- Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)(Intraoperative)
研究者
Jeeyoun Moon
Associate professor
Seoul National University