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Enrolling by invitation NCT05474274

PAIN (Pain AI iNtervention) Platform for Patients at Home

— Observational Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Machine learning algorithms.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Machine 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

Primary outcome measures

  • Using machine Learning for Postoperative Pain Pain Prediction [Time frame: 8 months]
Secondary outcome measures (2)
  • Physiologic variable %Δ defining the physiologic biomarker's change in measurements after pain medication [Time frame: 8 months]
  • Physiologic variable absolute Δ defining the physiologic biomarker's change in measurements after pain medication [Time frame: 8 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic Florida — Jacksonville

Identifiers

NCT: NCT05474274 · 21-013443

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗