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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Mobile Applications; Patient Satisfaction; Smartphone
• Intervention / Treatment: Device: A new smart device application (Smart APS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hojin Lee, PhD; Phone Number: 82-2-2072-2467; Email: hjpainfree@snu.ac.kr
• Study Contact Backup: Name: Soohyuk Yoon, MD; Phone Number: 82-2-2072-1645; Email: yoonsh3152@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, KS013
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hojin Lee, MD, PhD; Phone Number: 82-2-2072-2467; Email: zenerdiode03@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients using a new application; Patients will enter pain intensity and opioid analgesic side effects using a new application named 'Smart APS', developed for acute pain services, and later assess for adherence and satisfaction with the application use.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' adherence rate to Smart APS	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.	Postoperative day 1 and 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with pain management	Patient satisfaction with pain management using the 'Smart APS' app, rated on an 11-point scale (0 to 10 points, a higher number indicates higher satisfaction).	Postoperative day 2
Patient satisfaction with application usage	A survey of patient satisfaction with the use of the 'Smart APS' app, consisted of 6 questions which are rated on a 7-point scale.	Postoperative day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of spontaneous assessments	The number of spontaneous assessments made by the participant outside of the scheduled assessment time.	Whole study period (from the day of surgery to at least 2 days after surgery)
Amount of analgesics used	Total volume of patient-controlled analgesia used and rescue analgesics.	Whole study period (from the day of surgery to at least 2 days after surgery)
Patient satisfaction with the provided audio-visual educational materials	Patient satisfaction with the provided four audio-visual materials is evaluated on a 0-10 scale. (A higher score indicates higher satisfaction)	Postoperative day 2

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hojin Lee, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): April 28, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: 2304-053-1420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No