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.
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.
Study Type
OBSERVATIONAL
Enrollment
91
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of moderate to severe acute post-operative pain
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
Time frame: Postoperative Day 1 to 3
Incidence of chronic post-surgical pain
Patient's chronic pain condition will be assessed by Defense \& Veterans Pain Rating Scale (DVPRS) score one year after surgery, a DVPRS score ≥5 is considered as an existence of chronic pain
Time frame: 1 year after surgery
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