Development of the PAIN (Pain AI iNtervention) Platform for Patients at Home

Mayo Clinic1 site in 1 country70 target enrollmentNovember 23, 2022

ConditionsPain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pain
Sponsor: Mayo Clinic
Enrollment: 70
Locations: 1
Primary Endpoint: Using machine Learning for Postoperative Pain Pain Prediction
Status: Enrolling by Invitation
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to identify physiological markers to determine pain intensity and build an Artificial Intelligence (AI) enabled system to objectively measure pain intensity. Researchers hope to personalize pain medication regimens to help prevent medication over-use.

Registry

clinicaltrials.gov

Start Date

November 23, 2022

End Date

November 1, 2027

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Antonio J. Forte

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Patients undergoing low-risk outpatient plastic surgery procedures with expected pain intensities ranging from mild to severe.

Exclusion Criteria

•Patients with treated or untreated cardiopulmonary syndromes.
•Patients with treated or untreated ophthalmologic pathologies.
•Patients with skin pathologies that prevent us from using the TENS device.
•Patients with pathologies or conditions preventing them from appropriately using their voice.
•Patients with barriers to effective communication.
•Patients with poor digital literacy.
•Patients incapable of taking oral medication.
•Patients who are currently taking medical therapy for chronic pain.
•Patients with a previous diagnosis of severe anxiety disorders.
•Patients who are immobile at baseline.

Outcomes

Primary Outcomes

Using machine Learning for Postoperative Pain Pain Prediction

Time Frame: 8 months

The primary outcome will be the accuracy of machine learning algorithms for postoperative pain prediction using root mean square errors.

Secondary Outcomes

Physiologic variable absolute Δ defining the physiologic biomarker's change in measurements after pain medication(8 months)
Physiologic variable %Δ defining the physiologic biomarker's change in measurements after pain medication(8 months)