Clinical trial NCT06014918: 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
Overall status: RECRUITING
Phase: NA
Conditions: Mobile Applications
Pain, Postoperative
Smartphone
Patient Satisfaction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patients' adherence rate to Smart APS
timeFrame: Postoperative day 1 and 2
Secondary outcomes:
measure: Patient satisfaction with pain management
timeFrame: Postoperative day 2
measure: Patient satisfaction with application usage
timeFrame: Postoperative day 2
Other outcomes:
measure: Number of spontaneous assessments
timeFrame: Whole study period (from the day of surgery to at least 2 days after surgery)
measure: Amount of analgesics used
timeFrame: Whole study period (from the day of surgery to at least 2 days after surgery)
measure: Patient satisfaction with the provided audio-visual educational materials
timeFrame: Postoperative day 2
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hojin Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: