Development of a Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Incidence of moderate to severe acute post-operative pain
研究概览
简要总结
This study aims to develop a wearable electrocardiograph monitoring device and smartphone application in perioperative pain management, also to evaluate relationship between postoperative pain and heart rate variability.
详细描述
This study is a prospective observational cohort study implementing wearable electrocardiogram (ECG) monitor device and smartphone application in perioperative pain management. Patients undergoing major abdominal surgical procedures will be recruited to wear a ECG monitor device from the day before surgery until 1-3days after surgery. Patients will report their condition of pain twice daily on the corresponding smartphone application based on a structured and visualized pain report module. Patients will receive a telephone follow-up 30/60/90/365 days after surgery for assessment of postoperative chronic pain. A pilot study will be conducted to evaluate acceptability, safety and feasibility of the device and application using system usability scale and comprehensive product quality assessment. Further study will be conducted to evaluate the relationship between postoperative acute and chronic pain and heart rate variability (HRV) acquired from ECG device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing major abdominal surgical procedures;
- •18-65 years old;
- •ASA classification: I-IV
- •able to read and understand how to use the App after instruction；
- •written informed consent obtained.
排除标准
- •current participation in other mobile device research or perioperative pain research;
- •inability to use the device;
- •inability to obtain consent.
结局指标
主要结局
Incidence of moderate to severe acute post-operative pain
时间窗: Postoperative Day 1 to 3
Visual Analogue Scale (VAS) value of patients will be assessed after surgery for three consecutive days, any VAS value ≥ 4 will be considered as an event of moderate to severe acute post-operative pain
次要结局
- Incidence of chronic post-surgical pain(1 year after surgery)