Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video & movements recording, Questionnaires.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 6 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
Overview
The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.
Detailed description
The project is a prospective study designed to characterize behaviour and its psycho-physiological correlates of participants with ASD (children and adults) in comparison with subjects without ASD matched in age during blood test in common practice.
The aim is to analyse in an automated and standardised way video recording during a blood test performed as part of routine follow-up care for people presenting ASD (children and adults), qualitative data (type of emotion) and quantitative (intensity)
1. Emotional facial reactions 2. Behavioural reactions (video recording of participants' movements) 3. Physiological reactions (wireless smart watch worn on the wrist) 4. Psychological reactions (self and hetero questionaires) to characterize the signs of pain and anxiety associated with this situation)
Interventions
- Behavioral Video & movements recording
Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test - Behavioral Questionnaires
Passing self and hetero questionnaires of emotion felt and perceived.
Primary outcome measures
- Facial expression during blood sample [Time frame: through study completion, an average of 1 to 6 months]
- Body movement during blood sample [Time frame: through study completion, an average of 1 to 6 months]
Secondary outcome measures (1)
- Evaluation of emotion felt by participants during blood sample [Time frame: through study completion, an average of 1 to 6 months]
Eligibility criteria
Inclusion criteria
All participants :
- Person over 6 years of age
- Person who consent to participate in the study
- Membership of the social security scheme
- Person who not received analgesic treatment that may interfere with pain perception
- Person with medical prescription for blood sample
Participants with ASD :
- Person with ASD diagnosis
- If applicable, legal authority consent to participate in the study
Exclusion criteria
All participants :
- Person with unstabilized drug therapy
- Person with acute or chronic pain
- Person with pathology or receiving a treatment which can have an impact in modification of the pain
- Person with oculomotor and/or neuro-motor disorders
- Pregnant or breastfeeding woman
- Person with deprivation of liberty
- Person who no consent to participate in the study or no consent to realised video recording
Participants without ASD :
- Protected adult
- Person with ASD diagnosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Hospitalier Charles PERRENS — Bordeaux
Publications
- Hilton CL, Harper JD, Kueker RH, Lang AR, Abbacchi AM, Todorov A, LaVesser PD. Sensory responsiveness as a predictor of social severity in children with high functioning autism spectrum disorders. J Autism Dev Disord. 2010 Aug;40(8):937-45. doi: 10.1007/s10803-010-0944-8. PMID 20108030
- Hirvikoski T, Mittendorfer-Rutz E, Boman M, Larsson H, Lichtenstein P, Bolte S. Premature mortality in autism spectrum disorder. Br J Psychiatry. 2016 Mar;208(3):232-8. doi: 10.1192/bjp.bp.114.160192. Epub 2015 Nov 5. PMID 26541693
- Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. doi: 10.1001/archpedi.157.12.1219. PMID 14662579
- Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71. doi: 10.1017/s001216220400060x. PMID 15174527
- Dubois A, Rattaz C, Pry R, Baghdadli A. [Autism and pain - a literature review]. Pain Res Manag. 2010 Jul-Aug;15(4):245-53. doi: 10.1155/2010/749275. French. PMID 20808970
- Allely CS. Pain sensitivity and observer perception of pain in individuals with autistic spectrum disorder. ScientificWorldJournal. 2013 Jun 13;2013:916178. doi: 10.1155/2013/916178. Print 2013. PMID 23843740
Identifiers
NCT: NCT04638452 · 2020-A00693-36