Actively Recruiting

Phase Not Applicable
Age: 5Years - 70Years
All Genders
NCT05738278

Heart Rate Informed Changes in Care for Non-Communicating Patients

Led by University of Oslo · Updated on 2025-07-04

38

Participants Needed

2

Research Sites

148 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Heart Rate Informed Changes in Care for Non-Communicating Patients

Who Can Participate

Age: 5Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Oslo University Hospital

Oslo, Norway, 0192

Actively Recruiting

2

University of Oslo

Oslo, Norway, 0450

Actively Recruiting

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Research Team

B

Bjørnar Hassel, Professor

CONTACT

E

Emilie SM Kildal

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Heart Rate Informed Changes in Care for Non-Communicating Patients | DecenTrialz