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App for Acute Pain Service in Major Surgery

Primary Purpose

Mobile Applications, Pain, Postoperative, Smartphone

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
A new smart device application (Smart APS)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mobile Applications

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients using a new application

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
August 21, 2023
Last Updated
August 29, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06014918
Brief Title
App for Acute Pain Service in Major Surgery
Official Title
A Smart Device Application for Acute Pain Service in Patients Undergoing Major Surgery: A Prospective Observational Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobile Applications, Pain, Postoperative, Smartphone, Patient Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients using a new application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
A new smart device application (Smart APS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients' adherence rate to Smart APS
Description
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.
Time Frame
Postoperative day 1 and 2
Secondary Outcome Measure Information:
Title
Patient satisfaction with pain management
Description
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).
Time Frame
Postoperative day 2
Title
Patient satisfaction with application usage
Description
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.
Time Frame
Postoperative day 2
Other Pre-specified Outcome Measures:
Title
Number of spontaneous assessments
Description
The number of spontaneous assessments made by the participant outside of the scheduled assessment time.
Time Frame
Whole study period (from the day of surgery to at least 2 days after surgery)
Title
Amount of analgesics used
Description
Total volume of patient-controlled analgesia used and rescue analgesics.
Time Frame
Whole study period (from the day of surgery to at least 2 days after surgery)
Title
Patient satisfaction with the provided audio-visual educational materials
Description
Patient satisfaction with the provided four audio-visual materials is evaluated on a 0-10 scale. (A higher score indicates higher satisfaction)
Time Frame
Postoperative day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hojin Lee, PhD
Phone
82-2-2072-2467
Email
hjpainfree@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Soohyuk Yoon, MD
Phone
82-2-2072-1645
Email
yoonsh3152@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hojin Lee, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
KS013
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hojin Lee, MD, PhD
Phone
82-2-2072-2467
Email
zenerdiode03@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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App for Acute Pain Service in Major Surgery

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