App for Acute Pain Service in Major Surgery

Pain, Postoperative Clinical Trial

Official title:

A Smart Device Application for Acute Pain Service in Patients Undergoing Major Surgery: A Prospective Observational Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014918
• Other study ID #: 2304-053-1420
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: August 2023
• Source: Seoul National University Hospital
• Contact: Hojin Lee, PhD
• Phone: 82-2-2072-2467
• Email: hjpainfree[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Mobile Applications
• Pain, Postoperative
• Patient Satisfaction
• Smartphone

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Primary	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	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
Secondary	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