Skip to content

Prospective Validation of a Smartphone-based Multimodal AI Pain Assessment System versus the Visual Analogue Scale in Clinical Practice

Prospective Validation of a Smartphone-based Multimodal Artificial Intelligence Pain Assessment System versus the Visual Analogue Scale in Clinical Practice: A Single-Center Diagnostic Accuracy Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124131
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Pain (clinical pain assessment)

Interventions

Main cohort:None
Sub-cohort A (inter-operator reliability):None
Sub-cohort B (dynamic responsiveness):None

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Clinical patients (outpatient or inpatient) requiring pain assessment for any reason; 3. Signed informed consent by the participant or legal representative.

Exclusion criteria

Exclusion criteria: 1. Severe facial injury or complete facial occlusion postoperatively, precluding facial expression capture; 2. Deep sedation or coma (RASS <= -4); 3. Refusal to participate or withdrawal of informed consent; 4. Other conditions deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Nine-grid reclassification analysis (net reclassification improvement of AI vs. VAS against CRS);

Secondary

MeasureTime frame
Assessability coverage: success rate of AI vs. VAS assessment;Inter-operator reliability (ICC) of AI vs. VAS;Single-assessment duration of AI vs. VAS;

Countries

China

Contacts

Public ContactKe Penghui

Department of Pain Medicine, The First Affiliated Hospital of Anhui Medical University

864040149@qq.com+86 186 5591 1729

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026