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Multimodal AI-based pain measurement for intermediate care patients in the postoperative phase

Multimodal AI-based pain measurement for intermediate care patients in the postoperative phase - Intens#2

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036000
Enrollment
84
Registered
2025-04-02
Start date
2024-10-09
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Cognitively omnidirectional patients for whom a surgical procedure is planned within the next 3 days.

Interventions

Group 1: A multimodal data collection is carried out on preoperatively all-round oriented patients with recording of pain over the course of time (24 hours) including the intensification of drug pain
Statistical methods and machine learning methods
Publication. Study procedure: 1. examination of the inclusion and exclusion criteria 2. informing patients about the current version of the Declaration of Helsinki in oral and written form 3. explana

Sponsors

Medizinische Psychologie, Universitätsklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women aged >18 years; All-round oriented patients who are capable of being informed preoperatively; A surgical procedure is planned within the next 3 days, which requires monitoring in the intensive or intermediate care unit due to size and/or comorbidities; Written consent of the patient for the study.

Exclusion criteria

Exclusion criteria: Pregnancy; Neurological diseases associated with a restriction of peripheral conduction such as - paraplegia - Muscular dystrophy - Polyneuropathy (also in advanced diabetes mellitus, C2 abusus) - Critical illness polyneuropathy (CIP) - clinical suspicion, - Multiple sclerosis, Guillain-Barré syndrome, denervating neurological diseases - Cardiac pacemakers or electrical defibrillators - to date, no damage to such devices has been proven as a result of the applied currents. We want to avoid potential damage to the devices and thus a risk to the patient in any case! Subsequent withdrawal of consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
Transfer of our pain measurement technology evaluated in preliminary laboratory work into clinical application. The adapted technology will be validated on patients. Hypothesis: The pain intensities of the self-report or external report from NRS > 5 can be detected by the technology with a significantly higher than 85% detection rate.

Secondary

MeasureTime frame
To investigate the acceptance of non-intrusive sensor-based pain measurement technology by medical staff and patients and to determine the reasons for acceptance and rejection. Hypotheses: a) The age of the clinical staff has an influence on acceptance. b) Doctors from different specialties rate acceptance differently (non-directional). c) Patients accept a non-intrusive sensor-based pain detection technology. In addition, the achievable measurement quality is analyzed when scaling/reducing the sensor technology to subsets of the modalities, e.g. only EDA or only contactless video sensor technology.

Countries

Germany

Contacts

Public ContactSteffen Walter

Medizinische Psychologie, Universitätsklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Ulm

steffen.walter@uni-ulm.de+49 731 500 61910

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026