App for Acute Pain Service in Major Surgery

NCT ID: NCT06014918

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-04-28

Brief Summary

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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

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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

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Mobile Applications Pain, Postoperative Smartphone Patient Satisfaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

A new smart device application (Smart APS)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hojin Lee, MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hojin Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hojin Lee, PhD

Role: CONTACT

82-2-2072-2467

Soohyuk Yoon, MD

Role: CONTACT

82-2-2072-1645

Facility Contacts

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Hojin Lee, MD, PhD

Role: primary

82-2-2072-2467

Other Identifiers

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2304-053-1420

Identifier Type: -

Identifier Source: org_study_id

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