Heart Rate Monitoring to Detect Acute Pain in Non-verbal Patients: a Study Protocol for a Randomized Controlled Clinical Trial

Overview

Journal BMC Psychiatry

Publisher Biomed Central

Specialty Psychiatry

Date 2023 Apr 14

PMID 37060049

Authors

Emilie S M Kildal

Daniel S Quintana

Attila Szabo

Christian Tronstad

Ole Andreassen

Terje Naerland

Bjornar Hassel

Affiliations

Soon will be listed here.

Abstract

Background: Autism entails reduced communicative abilities. Approximately 30% of individuals with autism have intellectual disability (ID). Some people with autism and ID are virtually non-communicative and unable to notify their caregivers when they are in pain. In a pilot study, we showed that heart rate (HR) monitoring may identify painful situations in this patient group, as HR increases in acutely painful situations.

Objectives: This study aims to generate knowledge to reduce the number of painful episodes in non-communicative patients' everyday lives. We will 1) assess the effectiveness of HR as a tool for identifying potentially painful care procedures, 2) test the effect of 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.

Methods: We will recruit 38 non-communicative patients with autism and ID residing in care homes.

Assessments: HR is measured continuously to identify acutely painful situations. HR variability and pain-related 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 expressions of emotion and pain. Pre-intervention: HR is measured 8 h/day over 2 weeks to identify potentially painful situations across four settings: physiotherapy, cast use, lifting, and personal hygiene.

Intervention: Changes in procedures for identified painful situations are in the form of changes in 1) physiotherapy techniques, 2) preparations for putting on casts, 3) lifting techniques or 4) personal hygiene procedures.

Design: Nineteen patients will start intervention in week 3 while 19 patients will continue data collection for another 2 weeks before procedure changes are introduced. This is done to distinguish between specific effects of changes in procedures and non-specific effects, such as caregivers increased attention.

Discussion: This study will advance the field of wearable physiological sensor use in patient care.

Trial Registration: Registered prospectively at ClinicalTrials.gov (NCT05738278).

Citing Articles

Wearable Solutions Using Physiological Signals for Stress Monitoring on Individuals with Autism Spectrum Disorder (ASD): A Systematic Literature Review.

Cano S, Cubillos C, Alfaro R, Romo A, Garcia M, Moreira F Sensors (Basel). 2025; 24(24.

PMID: 39771872 PMC: 11679670. DOI: 10.3390/s24248137.

References

Gibbins S, Stevens B, McGrath P, Yamada J, Beyene J, Breau L . Comparison of pain responses in infants of different gestational ages. Neonatology. 2007; 93(1):10-8. DOI: 10.1159/000105520. View

Nuske H, Finkel E, Hedley D, Parma V, Tomczuk L, Pellecchia M . Heart rate increase predicts challenging behavior episodes in preschoolers with autism. Stress. 2019; 22(3):303-311. DOI: 10.1080/10253890.2019.1572744. View

Lauer E, McCallion P . Mortality of People with Intellectual and Developmental Disabilities from Select US State Disability Service Systems and Medical Claims Data. J Appl Res Intellect Disabil. 2015; 28(5):394-405. DOI: 10.1111/jar.12191. View

Picard R . Future affective technology for autism and emotion communication. Philos Trans R Soc Lond B Biol Sci. 2009; 364(1535):3575-84. PMC: 2781888. DOI: 10.1098/rstb.2009.0143. View

Baxter S, Enderby P, Evans P, Judge S . Interventions using high-technology communication devices: a state of the art review. Folia Phoniatr Logop. 2012; 64(3):137-44. DOI: 10.1159/000338250. View

Lotan M, Ljunggren E, Johnsen T, Defrin R, Pick C, Strand L . A modified version of the non-communicating children pain checklist-revised, adapted to adults with intellectual and developmental disabilities: sensitivity to pain and internal consistency. J Pain. 2009; 10(4):398-407. DOI: 10.1016/j.jpain.2008.09.006. View

Ali A, Hassiotis A . Illness in people with intellectual disabilities. BMJ. 2008; 336(7644):570-1. PMC: 2267944. DOI: 10.1136/bmj.39490.543137.80. View

Hatfield L, Ely E . Measurement of acute pain in infants: a review of behavioral and physiological variables. Biol Res Nurs. 2014; 17(1):100-11. DOI: 10.1177/1099800414531448. View

Akselrod S, Gordon D, Ubel F, Shannon D, Berger A, Cohen R . Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981; 213(4504):220-2. DOI: 10.1126/science.6166045. View

10.

Breau L, McGrath P, Camfield C, Finley G . Psychometric properties of the non-communicating children's pain checklist-revised. Pain. 2002; 99(1-2):349-57. DOI: 10.1016/s0304-3959(02)00179-3. View

11.

Szabo A, OConnell K, Ueland T, Sheikh M, Agartz I, Andreou D . Increased circulating IL-18 levels in severe mental disorders indicate systemic inflammasome activation. Brain Behav Immun. 2021; 99:299-306. DOI: 10.1016/j.bbi.2021.10.017. View

12.

Randich A, Maixner W . Interactions between cardiovascular and pain regulatory systems. Neurosci Biobehav Rev. 1984; 8(3):343-67. DOI: 10.1016/0149-7634(84)90057-5. View

13.

Chandler S, Charman T, Baird G, Simonoff E, Loucas T, Meldrum D . Validation of the social communication questionnaire in a population cohort of children with autism spectrum disorders. J Am Acad Child Adolesc Psychiatry. 2007; 46(10):1324-1332. DOI: 10.1097/chi.0b013e31812f7d8d. View

14.

Bray C, Bell L, Liang H, Haykal R, Kaiksow F, Mazza J . Erythrocyte Sedimentation Rate and C-reactive Protein Measurements and Their Relevance in Clinical Medicine. WMJ. 2017; 115(6):317-21. View

15.

Boerlage A, Valkenburg A, Scherder E, Steenhof G, Effing P, Tibboel D . Prevalence of pain in institutionalized adults with intellectual disabilities: a cross-sectional approach. Res Dev Disabil. 2013; 34(8):2399-406. DOI: 10.1016/j.ridd.2013.04.011. View

16.

Walia S, Wolfe D, Keast D, Ho C, Ethans K, Worley S . Facilitators and Barriers for Implementing an Internet Clinic for the Treatment of Pressure Injuries. Telemed J E Health. 2019; 25(12):1237-1243. DOI: 10.1089/tmj.2018.0196. View

17.

Choi M, Graves M, Matoo S, Storad Z, Idris R, Weck M . The small EF-hand protein CALML4 functions as a critical myosin light chain within the intermicrovillar adhesion complex. J Biol Chem. 2020; 295(28):9281-9296. PMC: 7363140. DOI: 10.1074/jbc.RA120.012820. View

18.

Alvarez P, Green P, Levine J . Role for monocyte chemoattractant protein-1 in the induction of chronic muscle pain in the rat. Pain. 2014; 155(6):1161-1167. PMC: 4303347. DOI: 10.1016/j.pain.2014.03.004. View

19.

Defrin R, Pick C, Peretz C, Carmeli E . A quantitative somatosensory testing of pain threshold in individuals with mental retardation. Pain. 2004; 108(1-2):58-66. DOI: 10.1016/j.pain.2003.12.003. View

20.

Cunha F, Lorenzetti B, Poole S, Ferreira S . Interleukin-8 as a mediator of sympathetic pain. Br J Pharmacol. 1991; 104(3):765-7. PMC: 1908235. DOI: 10.1111/j.1476-5381.1991.tb12502.x. View