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Идёт набор NCT05666921

Alexithymia and Attachment Style in Patients With Somatic Symptoms

Наблюдательное Somatic Symptom 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: psychological assessment.
Кому может быть актуально
Состояния в реестре: Somatic Symptom Disorder. Базовые параметры: 11 лет — 17 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Somatic Symptoms, Alexithymia and Styles of Attachment: a Cross-sectional Study

Обзор

To evaluate whether emotional awareness, attachment style and the ability to abstract and symbolize (IQ) influence the appearance of somatic symptoms. Hypothesis: the investigators expect the presence of somatic symptoms linked to the lower ability of emotional awareness, to lower ability to abstract and symbolize and to an insecure attachment style.

Подробное описание

Somatic Symptom Disorder (eg pain, weakness, chronic fatigue) represents one of the main reasons why patients seek specialist medical advice. Although the symptoms often manifest themselves in a disabling form and there are numerous medical examinations to which patients undergo, these do not seem to find an organic confirmation to their problem and consequently the patients do not receive a specific diagnosis. These are usually transient symptoms but it can happen that they become persistent and chronic, going to constitute themselves as real somatic syndromes. The study investigates the psychological and family aspects that seem to characterize somatic and chronic pain symptoms in pediatric age. In addition to this objective, the study aims to quantify the health costs incurred in the diagnostic phase prior to the classification of the somatic symptom. These elements would make it possible to achieve greater knowledge of clinical pictures and the identification of useful markers for the clinician to make early diagnoses and guide patients in a global and timely care.

Вмешательства

  • Другое psychological assessment
    The intervention consists in the assessment of some psychological aspects (emotional awareness, attachment style and the ability to abstract and symbolize (IQ)) of pediatric patients who present with somatic symptom disorders. , through specific tests. Each patient fills out the test battery during the psychological consult. At the same time, it is involved a parent to collect personal and clinical data through an ad hoc questionnaire.

Первичные конечные точки

  • Emotional awareness [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • attachment style [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • Ability to abstract and symbolize (IQ) [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
Вторичные конечные точки (9)
  • Stressful life events [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • Behavioral and emotional issues [Срок оценки: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • stress and protection indicators [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • pain coping strategies [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • Demographic and health variables [Срок оценки: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • Perceived pain, duration and impact on life areas [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • Parental Reflective Functioning [Срок оценки: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • Reflective Functioning [Срок оценки: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]
  • Medical and psychological factors related to pregnancy, post partum and lifestyle [Срок оценки: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.]

Критерии участия

Критерии включения

  • Clinical condition characterized by somatic symptoms such as recurrent abdominal pain, recurrent vomiting, dyspepsia, psychogenic cough, and chronic functional pain (headache, migraine, musculoskeletal pain) for which an organic cause has been excluded and whose symptom has had a strong impact on the quality of life (presence of the symptom for six months, school absenteeism, social isolation, immobility, psychological distress, difficulty in participating in sports and extracurricular activities, etc.), as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
  • Age between 11 and 17 years
  • Italian speaking
  • Patients' and parents' consent

Критерии исключения

  • Cognitive and/or developmental impairment
  • Difficulty in understanding the Italian language
  • Presence of organic disease diagnosis
  • Lack of informed consent
  • Patient who does not meet DSM-5 criteria for somatic symptom disorder

Caregiver exclusion criteria:

  • Cognitive deficits
  • Difficulty in understanding the Italian language
  • Lack of informed consent

Control group population inclusion criteria:

  • Age between 11 and 17 years
  • Adequate knowledge of the Italian language
  • Consent to participate

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 2 центра
  • Meyer Children's Hospital — Florence
  • IRCCS Gianna Gaslini — Genova

Публикации

  • Afari N, Ahumada SM, Wright LJ, Mostoufi S, Golnari G, Reis V, Cuneo JG. Psychological trauma and functional somatic syndromes: a systematic review and meta-analysis. Psychosom Med. 2014 Jan;76(1):2-11. doi: 10.1097/PSY.0000000000000010. Epub 2013 Dec 12. PMID 24336429
  • Andresen JM, Woolfolk RL, Allen LA, Fragoso MA, Youngerman NL, Patrick-Miller TJ, Gara MA. Physical symptoms and psychosocial correlates of somatization in pediatric primary care. Clin Pediatr (Phila). 2011 Oct;50(10):904-9. doi: 10.1177/0009922811406717. Epub 2011 May 16. PMID 21576182
  • Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1. PMID 8126686
  • Bonvanie IJ, Kallesoe KH, Janssens KAM, Schroder A, Rosmalen JGM, Rask CU. Psychological Interventions for Children with Functional Somatic Symptoms: A Systematic Review and Meta-Analysis. J Pediatr. 2017 Aug;187:272-281.e17. doi: 10.1016/j.jpeds.2017.03.017. Epub 2017 Apr 14. PMID 28416243
  • Cerutti R, Spensieri V, Valastro C, Presaghi F, Canitano R, Guidetti V. A comprehensive approach to understand somatic symptoms and their impact on emotional and psychosocial functioning in children. PLoS One. 2017 Feb 8;12(2):e0171867. doi: 10.1371/journal.pone.0171867. eCollection 2017. PMID 28178333
  • Coddington RD. The significance of life events as etiologic factors in the diseases of children. II. A study of a normal population. J Psychosom Res. 1972 Jun;16(3):205-13. doi: 10.1016/0022-3999(72)90045-1. No abstract available. PMID 5072914
  • Kascakova N, Furstova J, Hasto J, Madarasova Geckova A, Tavel P. The Unholy Trinity: Childhood Trauma, Adulthood Anxiety, and Long-Term Pain. Int J Environ Res Public Health. 2020 Jan 8;17(2):414. doi: 10.3390/ijerph17020414. PMID 31936285
  • Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084. PMID 25554755

Идентификаторы

NCT: NCT05666921 · somatic symptoms

Первоисточники (государственные реестры)

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