NCT04686526

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

October 26, 2020

Last Update Submit

July 26, 2023

Conditions

Pain, Postoperative

Keywords

heart rate variabilitypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of chronic post-surgical pain

    1 year after surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing major abdominal surgical procedures in Peking Union Medical College Hospital

You may qualify if:

  • patients undergoing major abdominal surgical procedures;
  • years old;
  • ASA classification: I-IV
  • able to read and understand how to use the App after instruction；
  • written informed consent obtained.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Li Xu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Che

CONTACT

69152020tracymaobao@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

December 28, 2020

Study Start

July 1, 2023

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

July 28, 2023

Record last verified: 2023-07

Locations

CN(1)