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Heart Rate Informed Changes in Care for Non-Communicating Patients

StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v3
  3. Primary and study completion dates: Oct 30, 2023 to Dec 30, 2025v2 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Start date: Aug 7, 2023 to Feb 27, 2023
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 3 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05738278
Lead Sponsor University of Oslo
Conditions
(from sponsor)		 Autism Spectrum Disorder, Intellectual Disability, Communication, Nonverbal
Related terms Autism Spectrum Disorder, Autistic Disorder, Communication, Developmental Disabilities, Intellectual Disability, Nonverbal Communication, Pain
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov