Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Oslo
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Situations identified by 2 standard deviation increase in HR
Overview
Brief 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.
Detailed Description
Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the objectives of the study, the identity of test and control treatments will not be known when analysing data. Access to the randomization code will be strictly controlled.
Eligibility Criteria
- Ages
- 5 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
Outcomes
Primary Outcomes
Situations identified by 2 standard deviation increase in HR
Time Frame: 11 weeks
The hypothesis is that a 2 standard deviation increase in HR can identify potentially painful care situations that require re-evaluation. Mean HR spike counts will be compared using a one-tailed paired sampled t-test to differentiate between suitable and unsuitable situations for care adjustments.
Secondary Outcomes
- HRV (ms)(6 weeks)
- Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)(6 weeks)
- Scores on quality of communication(6 weeks)
Investigators
Bjørnar Hassel
Professor
University of Oslo