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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrancesc Valenzuela Pascual

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Health professionals in Primary Care (medicine, physiotherapy, nursing, psychology, nutrition) and specialized setting; willingness to use the platform; institutional approval.

Disqualifiers

lack of institutional access; unavailability during pilot window

Trial design

Design model

Single group

Treatments tested in this trial

  • PainTrain-AI Behavioral Training

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: PainTrain-AI Behavioral TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Usability (SUS, 0-100)

Usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire that yields a score from 0 to 100. Higher scores indicate better usability. Participants will complete the SUS after interacting with the PainTrain-AI educational simulation for the predefined training period. The primary feasibility criterion is achieving a mean SUS score ≥75, indicating good usability.

Time frame
4-8 weeks after onboarding

Secondary outcomes

1

Concept Shift

Concept-shift will be assessed as the change in the proportion of predefined misconceptions about pain neurophysiology identified in a standardized scoring rubric. Participants will complete a brief conceptual test before and after exposure to the PainTrain-AI educational simulation. Concept-shift is calculated as the reduction in incorrect or outdated statements related to chronic pain mechanisms. Higher improvement reflects better conceptual understanding. No patient data are involved.

Time frame
4-8 weeks.
2

Adherence

Adherence will be measured as the proportion of scheduled training modules or simulation sessions that each participant completes within the study period. Adherence is calculated as the percentage of completed sessions relative to the total number of modules assigned. Higher values indicate greater engagement with the PainTrain-AI educational intervention. No patient data are involved.

Time frame
4-8 weeks
3

Latency/friction

Latency will be measured as the average system response time (in seconds) during user interactions with the PainTrain-AI digital simulation. Latency is calculated automatically from platform logs as the time elapsed between a user input and the system's generated response. Higher latency indicates greater technological friction. This outcome evaluates technical feasibility and user experience. No patient data are involved.

Time frame
4-8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Francesc Valenzuela Pascual

Lead sponsor

Universitat de Lleida

Sponsor institution

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