Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management

Pain, Postoperative Clinical Trial

Official title:

Development of a Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686526
• Other study ID #: ZS-2489
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Peking Union Medical College Hospital
• Contact: Lu Che
• Phone: 69152020
• Email: tracymaobao[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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