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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 protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3. |
|
| Control group | Active Comparator | After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR-informed change in routine | Behavioral | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Situations identified by 2 standard deviation increase in HR | 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. | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HRV (ms) | 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. | 6 weeks |
| Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml) |
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Inclusion Criteria:
Exclusion Criteria:
- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bjørnar Hassel, Professor | Contact | 0047 98829754 | bjornar.hassel@medisin.uio.no | |
| Emilie SM Kildal | Contact | 45481949 | eskildal@uio.no |
| Name | Affiliation | Role |
|---|---|---|
| Bjørnar Hassel | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | 0192 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33742078 | Background | 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. | |
| 37060049 | Derived |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D008607 | Intellectual Disability |
| D009633 | Nonverbal Communication |
| D001321 | Autistic Disorder |
| D002658 | Developmental Disabilities |
| D003142 | Communication |
| D010146 | Pain |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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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.
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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.
|
| Delayed HR-informed specific change in routine | Behavioral | 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:
|
|
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. |
| 6 weeks |
| Scores on quality of communication | 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. | 6 weeks |
| University of Oslo | Recruiting | Oslo | 0450 | Norway |
|
| 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. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |