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

• Conditions: (zeer) Ernstige meervoudige beperkingen; Intellectual developmental disorder; mental retardation

• Registration Number: NL-OMON48380
• Lead Sponsor: Vrije Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A physiological measurement and mobile app that can reliably distinguish<br /><br>between no pain and acute pain in persons with SID.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Changes or adjustments in care giving when receiving a pain warning from the<br /><br>Pain App<br /><br>- Changes in exploration and happiness after changes in care giving after<br /><br>receiving a pain wanrning from the Pain App<br /><br>- Information about user friendliness of the Pain App</p><br>