Clinical Trial

Heart Rate Informed Changes in Care for Non-Communicating Patients

Recruiting
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Record status
This record was last updated July 4, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-02-10; most recent amendment 2025-07-01.
Status change: Not Yet Recruiting → Recruiting 2024-02-16
Trial Details
NCT Number NCT05738278
Lead Sponsor University of Oslo
Conditions Autism Spectrum Disorder, Intellectual Disability, Communication, Nonverbal
Enrollment 38 participants
Start Date 2023-02-27
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-04