Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.