Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Facial expression during blood sample
Study 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)
- Emotional facial reactions
- Behavioural reactions (video recording of participants' movements)
- Physiological reactions (wireless smart watch worn on the wrist)
- Psychological reactions (self and hetero questionaires) to characterize the signs of pain and anxiety associated with this situation)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
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 (Behavioral)
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 (Behavioral)
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)