Clinical trial NCT05666921: Alexithymia and Attachment Style in Patients With Somatic Symptoms
Official title: Somatic Symptoms, Alexithymia and Styles of Attachment: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Somatic Symptom Disorder
Keywords: somatic symptoms
alexithymia
attachment style
pain
reflective function
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 300
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population under study is made up of pediatric patients (aged from 11 to 17), and an accompanying caregiver, belonging to the functional chronic pain clinic of Pain Therapy and Palliative Care, to the SOC of Gastroenterology and Nutrition, to the SOSA of Bronchopneumology and to the SOC of Medical Pediatrics as well as to the SOSA of Pediatric Hospital Psychology who present with somatic symptom disorders. All consecutive patients and accompanying caregivers who access the aforementioned services and who meet the expected inclusion criteria will be enrolled.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Emotional awareness
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: attachment style
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: Ability to abstract and symbolize (IQ)
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Secondary outcomes:
measure: Stressful life events
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: Behavioral and emotional issues
timeFrame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: stress and protection indicators
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: pain coping strategies
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: Demographic and health variables
timeFrame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: Perceived pain, duration and impact on life areas
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: Parental Reflective Functioning
timeFrame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: Reflective Functioning
timeFrame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
measure: Medical and psychological factors related to pregnancy, post partum and lifestyle
timeFrame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital
city: Genova
country: Italy
facility: IRCCS Gianna Gaslini
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Rosanna Martin, MSc
role: PRINCIPAL_INVESTIGATOR
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