Heart Rate Informed Changes in Care for Non-Communicating Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HR-informed change in routine, Delayed HR-informed specific change in routine.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder, Intellectual Disability, Communication, Nonverbal. Basic parameters: 5 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
Overview
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
Interventions
- Behavioral HR-informed change in routine
The intervention is given for a situation occuring at least ten times and accompanied by an increase in HR at least 80% of the time, during the two-week registration period. Change in care (intervention) is introduced from week 3. The intervention is in one of four forms: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for transp - Behavioral Delayed HR-informed specific change in routine
The intervention is given for a situation occuring at least twenty times and accompanied by an increase in HR at least 80% of the time, during the four-week registration period. Change in care (intervention) is introduced from week 5. The intervention is in one of four forms: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for tr
Primary outcome measures
- Situations identified by 2 standard deviation increase in HR [Time frame: 11 weeks]
Secondary outcome measures (3)
- HRV (ms) [Time frame: 6 weeks]
- Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml) [Time frame: 6 weeks]
- Scores on quality of communication [Time frame: 6 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Norway · 2 centers
- Oslo University Hospital — Oslo
- University of Oslo — Oslo
Publications
- Kildal E, Stadskleiv K, Boysen ES, Oderud T, Dahl IL, Seeberg TM, Guldal S, Strisland F, Morland C, Hassel B. Increased heart rate functions as a signal of acute distress in non-communicating persons with intellectual disability. Sci Rep. 2021 Mar 19;11(1):6479. doi: 10.1038/s41598-021-86023-6. PMID 33742078
- Kildal ESM, Quintana DS, Szabo A, Tronstad C, Andreassen O, Naerland T, Hassel B. Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2023 Apr 14;23(1):252. doi: 10.1186/s12888-023-04757-1. PMID 37060049
Identifiers
NCT: NCT05738278 · #2016/1956