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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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 | Postoperative Day 1 to 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing major abdominal surgical procedures in Peking Union Medical College Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Che | Contact | 69152020 | tracymaobao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Xu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |