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PAIN (Pain AI iNtervention) Platform for Patients at Home

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05474274
Enrollment
70
Registered
2022-07-26
Start date
2022-11-23
Completion date
2027-11-30
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Physiological markers for pain intensity, AI to objectively measure pain intensity, Medication over-use

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.

Interventions

OTHERMachine learning algorithms

Machine learning techniques to rank order physiologic variables obtained via the wearable and handheld devices as well as remove low-importance and redundant variables to accurately determine postoperative pain intensity in outpatients

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Using machine Learning for Postoperative Pain Pain Prediction8 monthsThe primary outcome will be the accuracy of machine learning algorithms for postoperative pain prediction using root mean square errors.

Secondary

MeasureTime frameDescription
Physiologic variable %Δ defining the physiologic biomarker's change in measurements after pain medication8 monthsThe secondary outcome will be the physiologic variable's use to define the physiologic biomarker's change in measurements after pain medication (%Δ in signal's respective units).
Physiologic variable absolute Δ defining the physiologic biomarker's change in measurements after pain medication8 monthsThe secondary outcome will be the physiologic variable's use to define the physiologic biomarker's change in measurements after pain medication (absolute Δ in signal's respective units).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026