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A physiological measure of nociceptive pain for persons with severe and profound intellectual and motor disability (SID)

A physiological measure of nociceptive pain for persons with severe and profound intellectual and motor disability (SID) - Physiological measure for pain: Persons with SID

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48380
Enrollment
70
Registered
2020-04-09
Start date
2019-12-02
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

(zeer) Ernstige meervoudige beperkingen Intellectual developmental disorder mental retardation

Interventions

The intervention used in this study is for the third research question. In this study, 4 persons with SID will be videotaped during two care moments while they are wearing the *smart sock*. The smar

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy: 18 years or over, (for 0 and 1A also under 56 years old), healthy, informed consent Patient: 18 years or over, severe or profound intellectual and multiple disability, informed consent of legal representative,

Exclusion criteria

Exclusion criteria: Healthy: No informed consent, pregnancy, heart disease or other medical disorder, under 18 years old, epilepsy with continuous episodes, disorder of the nervous system, history of frostbite, history of fainting/seizures, history of Reynaud's phenomenon, wound, sore or fracture to limb to be immersed. Patient: No informed consent from legal representative, disorder of the nervous system, under 18 years old, epilepsy with continuous episodes

Design outcomes

Primary

MeasureTime frame
A physiological measurement and mobile app that can reliably distinguish between no pain and acute pain in persons with SID.

Secondary

MeasureTime frame
- Changes or adjustments in care giving when receiving a pain warning from the Pain App - Changes in exploration and happiness after changes in care giving after receiving a pain wanrning from the Pain App - Information about user friendliness of the Pain App

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)