PAIN (Pain AI iNtervention) Platform for Patients at Home

NCT ID: NCT05474274

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-23

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-Surgery data collection system

Subjects undergoing standard of care low-risk plastic surgery be provided with wearable sensors to take home and start recording heart rate, body temperature and body movements

Machine learning algorithms

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Artificial Intelligence (AI) enabled system

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Antonio J. Forte

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Forte, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-013443

Identifier Type: -

Identifier Source: org_study_id