Using a wearable ECG device and app to manage postoperative pain
Development of a Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management
This study is testing a wearable heart monitor and an app to help people manage their pain after major abdominal surgery by tracking their pain levels and heart rate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 91 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04686526 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on developing a wearable electrocardiogram (ECG) monitoring device and a smartphone application to assist in managing pain after major abdominal surgeries. Patients will wear the ECG device from the day before their surgery until 1-3 days post-operation, reporting their pain levels twice daily through the app. The study will also include follow-up assessments for chronic pain at various intervals after surgery. Additionally, it aims to explore the relationship between postoperative pain and heart rate variability measured by the ECG device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 undergoing major abdominal surgical procedures.
Not a fit: Patients currently involved in other mobile device or perioperative pain research may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance postoperative pain management and improve recovery outcomes for patients.
How similar studies have performed: While the use of wearable devices in pain management is gaining traction, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Li Xu — Peking Union Medical College Hospital
- Study coordinator: Lu Che
- Email: tracymaobao@126.com
- Phone: 69152020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.