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Идёт набор NCT04638452

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

Без фазы С лечением Autism Spectrum Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Video & movements recording, Questionnaires.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 6 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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)

Вмешательства

  • Поведенческое Video & 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
  • Поведенческое Questionnaires
    Passing self and hetero questionnaires of emotion felt and perceived.

Первичные конечные точки

  • Facial expression during blood sample [Срок оценки: through study completion, an average of 1 to 6 months]
  • Body movement during blood sample [Срок оценки: through study completion, an average of 1 to 6 months]
Вторичные конечные точки (1)
  • Evaluation of emotion felt by participants during blood sample [Срок оценки: through study completion, an average of 1 to 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Charles PERRENS — Bordeaux

Публикации

  • Hilton CL, Harper JD, Kueker RH, Lang AR, Abbacchi AM, Todorov A, LaVesser PD. Sensory responsiveness as a predictor of social severity in children with high functioning autism spectrum disorders. J Autism Dev Disord. 2010 Aug;40(8):937-45. doi: 10.1007/s10803-010-0944-8. PMID 20108030
  • Hirvikoski T, Mittendorfer-Rutz E, Boman M, Larsson H, Lichtenstein P, Bolte S. Premature mortality in autism spectrum disorder. Br J Psychiatry. 2016 Mar;208(3):232-8. doi: 10.1192/bjp.bp.114.160192. Epub 2015 Nov 5. PMID 26541693
  • Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. doi: 10.1001/archpedi.157.12.1219. PMID 14662579
  • Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71. doi: 10.1017/s001216220400060x. PMID 15174527
  • Dubois A, Rattaz C, Pry R, Baghdadli A. [Autism and pain - a literature review]. Pain Res Manag. 2010 Jul-Aug;15(4):245-53. doi: 10.1155/2010/749275. French. PMID 20808970
  • Allely CS. Pain sensitivity and observer perception of pain in individuals with autistic spectrum disorder. ScientificWorldJournal. 2013 Jun 13;2013:916178. doi: 10.1155/2013/916178. Print 2013. PMID 23843740

Идентификаторы

NCT: NCT04638452 · 2020-A00693-36

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗