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Clinical Trials/NCT04638452
NCT04638452
Recruiting
N/A

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

Centre Hospitalier Charles Perrens, Bordeaux1 site in 1 country150 target enrollmentFebruary 8, 2021

Overview

Phase
N/A
Intervention
Video & movements recording
Conditions
Autism Spectrum Disorder
Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Enrollment
150
Locations
1
Primary Endpoint
Facial expression during blood sample
Status
Recruiting
Last Updated
last month

Overview

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)

Registry
clinicaltrials.gov
Start Date
February 8, 2021
End Date
February 28, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Video & movements recording

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.

Intervention: Questionnaires

Outcomes

Primary Outcomes

Facial expression during blood sample

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

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

Body movement during blood sample

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

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

Secondary Outcomes

  • Evaluation of emotion felt by participants during blood sample(through study completion, an average of 1 to 6 months)

Study Sites (1)

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