Heart Rate Informed Changes in Care for Non-Communicating Patients

Recruiting now · Not applicable

Conditions studied: Autism Spectrum Disorder, Intellectual Disability, Communication, Nonverbal

In brief

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.

Key facts

Study ID

NCT05738278

Run by

University of Oslo

People needed

38

Starts

2023-02-27

Expected to finish

2025-12-30

Last updated by the study team

2025-07-04

Who can join

Age: 5 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 5 and 70 years of age at the time of data collection
• Autism spectrum disorder as evaluated by clinical psychologist
• Communication difficulties
• Living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school/day-care at least five days a week.
• Written informed consent is obtained from the subjects' legal representative.

You may not qualify if…

• Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.

Where it is running

• Oslo University Hospital — Oslo, Norway (enrolling)
• University of Oslo — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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