A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR in the Treatment of Chronic Pain: a Multicenter, Randomized Controlled, Single Blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale/Score（VAS）
研究概览
简要总结
A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain
详细描述
Multi-center, prospective, single-blind, randomized and parallel controlled trials are used to evaluate the role and impact of "digital chronic pain treatment system equipment" based on MR mixed reality technology in the clinical basic treatment of patients clinically diagnosed with chronic pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old male and female;
- •Patients clinically diagnosed with chronic pain;
- •Chronic pain lasts for more than 3 months;
- •The average intensity of pain in the past month is 40mm and above (VAS);
- •Willing to abide by the relevant regulations of the experiment;
排除标准
- •Serious cognitive impairment;
- •Current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects;
- •Symptoms of nausea or dizziness;
- •Sensitive to luminous screens;
- •No stereo vision or severe hearing impairment;
- •Eye, face or neck injuries, which hinder the comfortable use of glasses;
- •The evaluated patient GAD-7 questionnaire 10 points and above, PHQ-9 questionnaire 10 points or above;
- •Have used VR or MR and other related devices to treat pain;
- •Other clinical studies have been completed now or recently (the past 2 months);
- •Currently pregnant or planning to get pregnant during the study;
- •At present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment.
结局指标
主要结局
Visual Analogue Scale/Score（VAS）
时间窗: 3 days
VAS pain score criteria ((0-10 points) 0 Points: painless; 3 points below: have a slight pain, can tolerate; 4 points- -6 points: patients with pain and affect sleep, and can still tolerate; 7 points-10 points: the patient has gradually intense pain, the pain is unbearable, affect appetite, affect sleep.
次要结局
未报告次要终点