How people with autism react during a routine blood draw
Evaluation of Behavioural, Psychological and Physiological Responses in People With Autism Spectrum Disorder (ASD) During a Blood Test in Routine Care Practice
This project tests whether children and adults with autism show different emotional, behavioral, and physiological reactions during a routine blood draw compared with people without autism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 6 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Charles Perrens, Bordeaux Government |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT04638452 on ClinicalTrials.gov |
What this trial studies
This prospective study records video of facial expressions and body movements, collects wrist-worn smartwatch data, and uses self- and observer-reported questionnaires during routine blood draws for participants with autism and age-matched controls. Video recordings will be analyzed in an automated and standardized way to quantify types of emotion and intensity, while movement and physiological signals provide objective correlates. The protocol excludes people with factors that might alter pain perception or movement, and matches controls by age. Data will be compared between groups to characterize the signature behavioral and psychophysiological responses associated with blood draws in people with autism.
Who should consider this trial
Good fit: Ideal candidates are people aged 6 years or older with a confirmed autism diagnosis who can consent (or have guardian consent) and who are scheduled for a routine blood test at the study site.
Not a fit: People with unstable medication, acute or chronic pain, neuro-motor or oculomotor disorders, pregnant or breastfeeding individuals, those deprived of liberty, or anyone unwilling or unable to be video recorded are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians and caregivers recognize and reduce pain and anxiety during blood draws for people with autism.
How similar studies have performed: Automated video analysis and wearable monitoring have shown promise for detecting pain and anxiety in other groups, but applying these tools specifically to people with autism during routine blood draws is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 * Person with ASD diagnosis
Where this trial is running
Bordeaux
- Centre Hospitalier Charles PERRENS — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Anouck AMESTOY, MD
- Email: aamestoy@ch-perrens.fr
- Phone: 0556566719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.