Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07497997
Acronym
PT-AI Pilot
Enrollment
40
Registered
2026-03-27
Start date
2027-01-01
Completion date
2028-09-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Musculoskeletal Pain

Keywords

chronic musculoskeletal pain, clinical simulation, digital training, educational intervention, usability (SUS), concept shift, primary care professionals

Brief 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.

Detailed description

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.

Interventions

BEHAVIORALPainTrain-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

Francesc Valenzuela Pascual
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

This is an open-label feasibility study. No masking is applied. All participants receive the same behavioral educational intervention, and the study does not involve patient data or clinical outcomes that require blinded assessment.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Usability (SUS, 0-100)4-8 weeks after onboardingUsability 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

MeasureTime frameDescription
Concept Shift4-8 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.
Adherence4-8 weeksAdherence 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/friction4-8 weeksLatency 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.

Countries

Spain

Contacts

CONTACTFran Valenzuela-Pascual, Dr
fran.valenzuela@udl.cat+34 973 702 459
PRINCIPAL_INVESTIGATORFran Valenzuela-Pascual, Dr.

Institut de Recerca Biomèdica de Lleida (IRBLleida) / Universitat de Lleida (UdL)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026