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临床试验/NCT05666921
NCT05666921招募中不适用

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

Meyer Children's Hospital IRCCS2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
2
主要终点
attachment style

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

attachment style

时间窗: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

The Saparation Anxiety Test - SAT, Italian version adapted from Attili (2001) is a semi-projective tool aimed at measuring the attachment style of the child and adolescent, through the analysis of reactions and verbal responses to stimuli that illustrate 6 hypothetical situations of separation by parental figures. The responses are then classified into 8 categories which calculate a score that is compared with reference score ranges that correspond to 4 different attachment styles. Specifically, scores equal to or greater than 4 indicate secure attachment, scores between 3 and 1 an ambivalent insecure attachment, scores between 0 and -2 an avoidant insecure attachment, and finally scores equal to or lower than -3 are indicative of an attachment style disorganized / confused.

Ability to abstract and symbolize (IQ)

时间窗: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

Raven's Standard Progressive Matrices - SPM-RA (Raven, 1982), are a test that aims to measure the general factor of fluid intelligence. the test consists of four series (A, B, C, D) of 12 items each of increasing complexity. It is an excellent test from both a psychometric and a factorial point of view. The updated report - SPM-RA (prepared by Picone, Orsini and Pezzuti) will be used as a reference for the test scoring, which allows the instrument to be used for a sample aged 6 to 18. An intelligence score above 25/36 indicates an above average intelligence level, scores between 17/36 and 25/36 are to be considered indicative of an average intelligence level, scores below 17/36 below average intelligence medium (Picone, Orsini and Pezzuti)

Emotional awareness

时间窗: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

Emotion Awareness Questionnaire - EAQ-30 (Rieffe et al., 2008; Camodeca \& Rieffe, 2013) The EAQ is a self-report test aimed at measuring the emotional awareness of children and adolescents, it is composed of 6 subscales and 30 items and has a Likert scale of 3 points. High scores obtained at the different subscales indicate a high emotional awareness. The cut offs are specific for age and sex, for the interpretation of the scores reference is made to the scores obtained by the control group in the study by Camodeca et al., 2013.

次要结局

  • Behavioral and emotional issues(Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.)
  • Parental Reflective Functioning(Parents 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(Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.)
  • Demographic and health variables(Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.)
  • stress and protection indicators(Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.)
  • pain coping strategies(Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.)
  • Reflective Functioning(Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.)
  • Stressful life events(Patients 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(Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.)

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosanna Martin

Principal Investigator

Meyer Children's Hospital IRCCS

研究点 (2)

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