NCT06014918

App for Acute Pain Service in Major Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mobile Applications
• Pain, Postoperative
• Smartphone
• Patient Satisfaction

Interventions

Type	Name	Description
DEVICE	A new smart device application (Smart APS)	The application sends alarms to patients to enter their pain intensity and opioid-related side effects at the times set by the researcher. Additional entries for severe pain or opioid side effects are also available at any other time. Researchers can monitor the results in real-time via an integrated web program. If a red flag sign is observed during regular office hours, an anesthesiologist participating in the research will visit the patient for assessment and intervention. In addition, patients can watch pre-made perioperative pain-related educational videos through the smart APS.

Timeline

• Start date: 2023-08-28
• Primary completion: 2024-02-28
• Completion: 2024-04-28
• First posted: 2023-08-28
• Last updated: 2023-08-30

Locations

1 site across 1 country: South Korea