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NCT Number: NCT07497997

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This feasibility pilot will evaluate the use of PainTrain AI, a behavioral educational intervention designed to improve clinical reasoning about chronic pain through simulated dialogues with virtual standardized patients. The platform uses a Retrieval Augmented Generation (RAG) safety architecture that restricts all generated responses to validated pedagogical content and does not provide clinical advice. No patient information is collected.

The study includes health professionals from Primary Care and a specialized comparative setting. Participants will complete a baseline assessment and then interact with the PainTrain AI simulation for a defined training period. Usability will be assessed using the System Usability Scale (SUS). Concept shift will be measured as the reduction in predefined neurophysiology misconceptions scored through a standardized rubric. Additional metrics include adherence to micromodules and interaction latency as indicators of technological friction.

This pilot aims to determine feasibility, acceptability, and preliminary signals of educational effectiveness to inform a future implementation trial in Primary Care. The intervention is educational only, non diagnostic, and GDPR compliant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • lack of institutional access; unavailability during pilot window

Treatment and study plan

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.

Primary outcomes

  1. Usability (SUS, 0-100)

    Time frame: 4-8 weeks after onboarding

    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

  1. Concept Shift

    Time frame: 4-8 weeks.

    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.

  2. Adherence

    Time frame: 4-8 weeks

    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.

  3. Latency/friction

    Time frame: 4-8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fran Valenzuela-Pascual, Dr

CONTACT

[email protected]

+34 973 702 459

Sponsors and collaborators

Lead sponsor

Francesc Valenzuela Pascual

Other

Registry information

Official study title

Feasibility and Usability of a Digital Clinical Simulation (PainTrain AI) for Chronic Pain Training in Health Professionals: A Multicenter Pilot in Primary Care (ICS) and a Specialized Comparative Setting

Acronym: PT-AI Pilot

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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