NCT05738278Recruiting
Heart Rate Informed Changes in Care for Non-Communicating Patients
Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 27 Oct 2022
- Start date
- 27 Feb 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- University of Oslo
- Diseases
- Autism
- NCT number
- NCT05738278
What you commit to
- Study type: Interventional
- Planned participants: 38
- From 27 Feb 2023 to the primary completion date, 30 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
Who the study is looking for
- 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.
Age in the registry: 5 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Oslo Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.