PAIN (Pain AI iNtervention) Platform for Patients at Home

• Conditions: Pain
• Interventions: Other: Machine learning algorithms

• Registration Number: NCT05474274
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-25
• Study First Posted: 2022-07-26
• Study Start: 2022-11-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Surgery data collection system	Machine learning algorithms	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

Primary Outcome Measures

Name	Time	Method
Using machine Learning for Postoperative Pain Pain Prediction	8 months	The primary outcome will be the accuracy of machine learning algorithms for postoperative pain prediction using root mean square errors.

Secondary Outcome Measures

Name	Time	Method
Physiologic variable absolute Δ defining the physiologic biomarker's change in measurements after pain medication	8 months	The 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).
Physiologic variable %Δ defining the physiologic biomarker's change in measurements after pain medication	8 months	The 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).

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States