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PainTrain-AI Pilot: Feasibility, Usability (SUS) and Concept-Shift in Primary Care and a Specialized Setting

NCT07497997 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-02

No results posted yet for this study

Summary

This pilot will assess feasibility and usability (SUS) and explore concept shift (reduction of neurophysiology misconceptions) after exposure to a behavioral educational intervention (PainTrain AI), a digital clinical simulation "fenced" by evidence (RAG) for safe, non diagnostic training. The study will be conducted in Primary Care and in a specialized comparative setting, without patient data collection. Primary endpoint: SUS score. Secondary endpoints: concept shift, adherence to micromodules, and interaction latency as friction metric. The platform does not generate clinical advice; it retrieves validated teaching content.

Conditions

  • Chronic Musculoskeletal Pain

Interventions

BEHAVIORAL

PainTrain-AI Behavioral Training

PainTrain-AI is a behavioral educational intervention delivered through a digital clinical simulation platform. The system uses a retrieval-augmented generation (RAG) safety architecture to ensure that all responses are generated only from validated pedagogical content. Participants engage in simulated dialogues with virtual standardized patients to practice biopsychosocial reasoning about chronic pain. The intervention is non-diagnostic, does not provide clinical advice, and does not involve patient data. All participants receive the same intervention.

Sponsors & Collaborators

  • Francesc Valenzuela Pascual

    lead OTHER

Principal Investigators

  • Fran Valenzuela-Pascual, Dr. · Institut de Recerca Biomèdica de Lleida (IRBLleida) / Universitat de Lleida (UdL)

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-01-31
Completion
2028-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07497997 on ClinicalTrials.gov