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 volunteersQualifiers
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
Single group
Treatments tested in this trial
PainTrain-AI Behavioral Training
BehavioralPainTrain-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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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 Concept-shift is calculated as the reduction in incorrect or outdated statements related to chronic pain mechanisms.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.
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.
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.
Sponsors and contacts
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Francesc Valenzuela Pascual
Lead sponsor
Universitat de Lleida
Sponsor institution
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