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Clinical Trials/NCT06014918
NCT06014918
Recruiting
Not Applicable

A Smart Device Application for Acute Pain Service in Patients Undergoing Major Surgery: A Prospective Observational Feasibility Study

Seoul National University Hospital1 site in 1 country60 target enrollmentAugust 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mobile Applications
Sponsor
Seoul National University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Patients' adherence rate to Smart APS
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The app will be installed on the patient's smartphone before surgery. Patients will receive reminders to record their pain intensity and opioid-related side effects at the pre-determined time points until at least 2 days after surgery. The patient's compliance with the reminders will be assessed. On the second postoperative day, their satisfaction with pain control and app usage will be evaluated. Patients can also provide feedback on any issues they have encountered with the app during the study period.

Detailed Description

Following admission, the application will be installed on the enrolled patient's smartphone prior to surgery, and the patient will be instructed on the content of the program and how to use it. Educational videos within the app about postoperative pain control will be introduced to the patient at this time. At the pre-determined time points, until at least 2 days post-operatively, the patient will be reminded of the assessment via an alarm function and will enter post-operative pain intensity using an 11-point numeric rating scale or verbal rating scale and the presence of opioid-related side effects into the application. If a patient responds to the alarm 2 or more times per day, they will be considered to be compliant. Postoperative opioid consumption using patient-controlled analgesia and the amount of rescue analgesics will be assessed. Patients will be assessed with a survey on postoperative day 2 for overall satisfaction with pain control and usage of the application. Patients will also be able to provide feedback via the application or research staff on any errors or inconveniences they may have experienced while using the application throughout the study.

Registry
clinicaltrials.gov
Start Date
August 28, 2023
End Date
April 28, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hojin Lee, MD

Associate professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patients aged 19 to 70 years who are scheduled for regular major surgery
  • American Society of Anesthesiologists (ASA) physical status classification I or II
  • Patients who are using a smartphone and are not expected to have any restrictions on application use

Exclusion Criteria

  • Unable to communicate
  • Patients under the age of 19 and over the age of 70
  • Patients who, in the opinion of the investigator or study staff, are not appropriate for this study

Outcomes

Primary Outcomes

Patients' adherence rate to Smart APS

Time Frame: Postoperative day 1 and 2

Proportion of patients who successfully used the smart APS among all patients.. Through Smart APS, a self-assessment is conducted three times a day, and it is assumed that the application has been used successfully if the patient completes an evaluation of pain intensity and opioid analgesic side effects at least twice on the first and second days after surgery.

Secondary Outcomes

  • Patient satisfaction with pain management(Postoperative day 2)
  • Patient satisfaction with application usage(Postoperative day 2)

Study Sites (1)

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