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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-65
SponsorCentre Hospitalier Charles Perrens, Bordeaux

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Video & movements recording

    Behavioral

    Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test

  • Questionnaires

    Behavioral

    Passing self and hetero questionnaires of emotion felt and perceived.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: EpidemiologyOther 2 interventions

Trial outcomes

Primary outcomes

1

Facial expression during blood sample

Evaluation of facial expression during blood sample in people with ASD as compared to healthy people with Face reader, Noldus sofware.

Time frame
through study completion, an average of 1 to 6 months
2

Body movement during blood sample

Evaluation 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

Time frame
through study completion, an average of 1 to 6 months

Secondary outcomes

1

Evaluation of emotion felt by participants during blood sample

Evaluation 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

Time frame
through study completion, an average of 1 to 6 months

Other outcomes

Sponsors and contacts

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