Evidence map›Paper›PMID 37060049›Full record

ArticleBMC psychiatry2023

Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial.

Emilie S M Kildal, Daniel S Quintana, Attila Szabo, Christian Tronstad, Ole Andreassen, Terje Nærland, Bjørnar Hassel

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04199299 recruitingnot on this map

The Use of Sensors to Improve Communication for Persons With Intellectual Disability Who Cannot Communicate Unequivocally

TypeobservationalSponsorUniversity of OsloRan2020 to 2032Enrolled100ConditionsIntellectual Disability, Autism, Cerebral PalsyArmsHeart rate and respiration rate sensors
NCT05738278 narecruitingnot on this map

Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial

TypeinterventionalSponsorUniversity of OsloRan2023 to 2025Enrolled38ConditionsAutism Spectrum Disorder, Intellectual Disability, Communication, NonverbalArmsHR-informed change in routine, Delayed HR-informed specific change in routine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Comparison of behavioural, physiological, and self-reported pain responses in Pakistani children with dental pain: a descriptive cross-sectional study.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2025
    Trial
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Emilie S M KildalK.G. Jebsen, Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway. eskildal@uio.no.
Daniel S QuintanaK.G. Jebsen, Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway.
Attila SzaboK.G. Jebsen, Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway.
Christian TronstadDepartment of Clinical and Biomedical Engineering, Oslo University Hospital, Oslo, Norway.
Ole AndreassenK.G. Jebsen, Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway.
Terje NærlandK.G. Jebsen, Centre for Neurodevelopmental Disorders, University of Oslo, Oslo, Norway. terje.narland@uio.no.
Bjørnar HasselInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
University of Oslo · NOOslo University Hospital · NOLovisenberg Diakonale Sykehus · NONorwegian Biochemical (Norway) · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutism 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.

objectivesThis 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.

methodsWe 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.

interventionChanges 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.

designNineteen 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 registrationRegistered prospectively at ClinicalTrials.gov (NCT05738278).

Indexed as

Acute PainAutistic DisorderEmotionsHeart Rate DeterminationHumansPilot ProjectsRandomized Controlled Trials as TopicAcute painAutism spectrum disorderAutonomic nervous systemHealth technologyHeart rate monitorNon-verbal patients

Identifiers

PMID37060049
PMCPMC10103503
OpenAlexW4365811020

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.