Autism Spectrum Disorder, Communication, Nonverbal, Intellectual Disability
Conditions
Keywords
Heart Rate, Autistic Disorder, Intellectual Disability, Social Interaction, Caregivers, Developmental Disabilities, Communication, Biomarkers, Pain
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
Interventions
BEHAVIORALHR-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 transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.
BEHAVIORALDelayed 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 transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.
Sponsors
University of Oslo
Study design
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.
Intervention model description
Thirty-eight non-verbal patients are recruited. HR is taken as a marker of acute pain. HR-Variability (HRV) and pain-related inflammatory cytokines (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) are collected as measures of long-term pain. Caregivers will be asked to what degree they observe pain in their patients and how well they believe they understand their patient's expression. Collection is set to primary care institutions. HR is measured 8 hours/day over 2 weeks to identify increase of HR associated with potentially painful situations. Changes in procedures are in the form of change in 1) rigorousness of stretching, 2) preparations for casts, 3) lifting technique, or 4) personal hygiene procedure. To differentiate effects due to procedure-change from effects of covariates such as increased attentiveness when using HR; half the study group will start intervention in week 3 while the delayed group will continue data collection for another 2 weeks before introducing procedure changes.
Eligibility
Sex/Gender
ALL
Age
5 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Situations identified by 2 standard deviation increase in HR | 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
| Measure | Time frame | Description |
|---|---|---|
| HRV (ms) | 6 weeks | The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related biomarkers of HRV as evaluated at the beginning and the end of the study period. |
| Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml) | 6 weeks | The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related blood biomarkers (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) as evaluated at the beginning and the end of the study period. |
| Scores on quality of communication | 6 weeks | The hypothesis is that HR as an aid in communication will increase caregivers' understanding of the patient as measured by changes in perceived understanding of the patient from the beginning to the end of the study period. |
Countries
Norway
Contacts
Primary ContactBjørnar Hassel, Professor
Backup ContactEmilie SM Kildal
Outcome results
None listed