App for Acute Pain Service in Major Surgery

NCT06014918 | Unknown

• 1 other identifier: 2304-053-1420
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobile Applications; Pain, Postoperative; Smartphone; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient satisfaction with pain management

  Postoperative day 2

• Patient satisfaction with application usage

  Postoperative day 2

Other Outcomes (3)

• Number of spontaneous assessments

  Whole study period (from the day of surgery to at least 2 days after surgery)

• Amount of analgesics used

  Whole study period (from the day of surgery to at least 2 days after surgery)

• Patient satisfaction with the provided audio-visual educational materials

  Postoperative day 2

Study Arms (1)

Patients using a new application

EXPERIMENTAL

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)

Interventions

A new smart device application (Smart APS) DEVICE

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.

Patients using a new application

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, KS013, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hojin Lee, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hojin Lee, PhD

CONTACT

82-2-2072-2467; hjpainfree@snu.ac.kr

Soohyuk Yoon, MD

CONTACT

82-2-2072-1645; yoonsh3152@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As this is an observational study to assess feasibility, the participants, care providers, researchers, and outcome assessors cannot be masked by the nature of the design.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study is designed to examine the feasibility of a smart device application to assess and manage postoperative pain in a single group of patients undergoing major surgery.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: August 28, 2023
• Primary Completion: February 28, 2024
• Study Completion: April 28, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)