Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management

Recruiting

• Conditions: Pain, Postoperative

• Registration Number: NCT04686526
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-28
• Status Verified: 2023-07
• Study Start: 2023-07-01
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• 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.

Exclusion Criteria

• current participation in other mobile device research or perioperative pain research;
• inability to use the device;
• inability to obtain consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of moderate to severe acute post-operative pain	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

Secondary Outcome Measures

Name	Time	Method
Incidence of chronic post-surgical pain	1 year after surgery	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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China