Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice
NCT ID: NCT04638452
Last Updated: 2021-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2021-02-08
2024-02-28
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Epidemiology
Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test Passing self and hetero questionnaires of temotion felt and perceived.
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
Questionnaires
Passing self and hetero questionnaires of emotion felt and perceived.
Interventions
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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
Questionnaires
Passing self and hetero questionnaires of emotion felt and perceived.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
65 Years
ALL
Yes
Sponsors
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Centre Hospitalier Charles Perrens, Bordeaux
OTHER_GOV
Responsible Party
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Principal Investigators
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Anouck AMESTOY, MD
Role: STUDY_DIRECTOR
Physician
Locations
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Centre Hospitalier Charles PERRENS
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-A00693-36
Identifier Type: -
Identifier Source: org_study_id
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