Skip to content

Evaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice

Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04638452
Acronym
AUTICOPP
Enrollment
150
Registered
2020-11-20
Start date
2021-02-08
Completion date
2027-02-28
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorders, behaviour, emotions, Physiological reactions, Psychological reactions

Brief summary

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

BEHAVIORALVideo & 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

BEHAVIORALQuestionnaires

Passing self and hetero questionnaires of emotion felt and perceived.

Sponsors

Centre Hospitalier Charles Perrens, Bordeaux
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Epidemiology

Eligibility

Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Facial expression during blood samplethrough study completion, an average of 1 to 6 monthsEvaluation of facial expression during blood sample in people with ASD as compared to healthy people with Face reader, Noldus sofware.
Body movement during blood samplethrough study completion, an average of 1 to 6 monthsEvaluation of body movement during blood sample in people with ASD as compared to healthy people with EMPATICA watch and Face, Legs, Activity, Cry, Consolabilty (FLACC) scale

Secondary

MeasureTime frameDescription
Evaluation of emotion felt by participants during blood samplethrough study completion, an average of 1 to 6 monthsEvaluation of emotion felt by participants (anxiety, stress, pain, apprehension…) during blood sample with implified Scale for Assessing Pain in Dyscommunicatives People with Autism Spectrum Disorders (ESSDA) and Pain Assessment Grid - Intellectual Disability (GEDDI) scales

Countries

France

Contacts

CONTACTAnouck AMESTOY, MD
aamestoy@ch-perrens.fr0556566719
CONTACThelen SAVARIEAU
hsavarieau@ch-perrens.fr0556563556
STUDY_DIRECTORAnouck AMESTOY, MD

Physician

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026