Validation of PainChek tool for individuals with dementia in the UK
Research type
Research Study
Full title
A Research into the Validity, Accuracy and Feasibility of PainChek - an electronic pain assessment tool for Individuals with Dementia in UK Care Homes.
IRAS ID
223179
Contact name
Ivana Babicova
Contact email
Sponsor organisation
Birmingham City University/Faculty of Health, Education & Life Sciences Research Office
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
The aim of the study is to validate a newly developed electronic pain assessment intervention called PainChek™, has received the CE Mark and TGA clearance as a Class 1 Medical Device in Australia. PainChek™ is a smartphone app which utilises facial recognition technology to scan face of an individual to detect micro-facial expressions which are indicative of presence of pain. The facial pain data are then combined with non-facial pain cues (such as vocalisation, movements and behaviour) to calculate a pain score.
In this case, PainChek™ will be validated on residents with dementia from Orchard Care Homes – which is one of the collaborators of this study. The CI will ensure that the participants meet the cognitive impairment/dementia criteria by assessing their cognition using a well-known assessment scale called Mini-Mental State Examination, which consists of 11 questions designed to help determine the degree of cognitive impairment.
The validation will be achieved through direct comparison of PainChek™ to the "gold standard" of observational pain assessment tools - Abbey Pain Scale (APS). To achieve this, each participant will be assessed for pain twice in one "session" – at rest, and post-movement. The first time by administration of PainChek™ and APS while the resident is at a resting state (e.g. sitting down). The second time, the participant pain will be assessed post-movement (e.g. participant will be asked to stand up, walk a few steps). The two assessments (in both, rest and post-movement sessions) will be taken within close proximity to each other, to ensure pain levels and behaviours have not changed significantly.
Participants might be assessed up to 20 times using both pain assessment tools during the length of the study (approximately 12-16 weeks), however never more than once per day.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
18/WM/0192
Date of REC Opinion
7 Sep 2018
REC opinion
Further Information Favourable Opinion