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Идёт набор NCT07327775

Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit/Hyperactivity Disorder

— Наблюдательное Fibromyalgia Syndrome Disease Burden Attention-Deficit/Hyperactivity 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: Disease Burden.
Кому может быть актуально
Состояния в реестре: Fibromyalgia Syndrome, Disease Burden, Attention-Deficit/Hyperactivity Disorder. Базовые параметры: 18 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Is the Disease Burden of Fibromyalgia Syndrome Higher in Mothers of Children With Attention-Deficit/Hyperactivity Disorder? A Prospective Controlled Study

Обзор

In this study, the investigators aimed to evaluate the impact of having a child diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) on parental disease burden in mothers diagnosed with Fibromyalgia Syndrome (FMS). The study will include 50 mothers with FMS who have a child diagnosed with ADHD and 50 mothers with FMS who have children without any psychiatric disorders. Among mothers of children followed with a diagnosis of ADHD at the Child and Adolescent Psychiatry Outpatient Clinic of Edirne Sultan 1st Murat State Hospital, the presence of widespread body pain will be assessed. Mothers reporting widespread body pain will be referred to the Pain Management Outpatient Clinic of the same hospital for further evaluation for FMS. Mothers diagnosed with FMS will be included in the study group. The comparison group will consist of mothers with FMS who have children without any psychiatric disorders. These participants will be selected from patients diagnosed with FMS who present to the Pain Management Outpatient Clinic of Edirne Sultan 1st Murat State Hospital.

Вмешательства

  • Другое Disease Burden
    The demographic characteristics of the participants included in the study-age, educational level, occupation, socioeconomic status, marital status, number of children, and number of children diagnosed with ADHD-will be recorded, and body mass index (BMI) will be calculated. The duration of symptoms will be assessed in months. Pain intensity in all patients will be evaluated using the Visual Analog Scale (VAS). To assess quality of life and functional status, the Fibromyalgia Impact Questionnai

Первичные конечные точки

  • pain severity [Срок оценки: Baseline]
  • quality of life and functional status [Срок оценки: Baseline]
  • level of central sensitization [Срок оценки: Baseline]

Критерии участия

Критерии включения

Inclusion Criteria for Participants with Children Diagnosed with ADHD:

  • Being a female aged between 18 and 50 years
  • Having one or more children aged 6-17 years diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD) according to DSM-5 diagnostic criteria
  • Having a diagnosis of Fibromyalgia Syndrome (FMS according to the 2016 American College of Rheumatology \[ACR\] criteria)
  • Being literate

Inclusion Criteria for Participants with Children Without Psychiatric Disorders:

  • Being a female aged between 18 and 50 years
  • Having one or more children aged 6-17 years without any psychiatric disorders
  • Having a diagnosis of Fibromyalgia Syndrome (FMS) according to the 2016 American College of Rheumatology (ACR) criteria
  • Being literate

Критерии исключения

  • Receiving regular pharmacological treatment for Fibromyalgia Syndrome
  • Having an active psychiatric disorder or using psychiatric medication
  • Having a history of infectious disease, chronic inflammatory disease, or malignancy
  • Being pregnant or breastfeeding
  • Having a central or peripheral nervous system disorder (e.g., cerebrovascular disease, multiple sclerosis)
  • Being uncooperative during clinical evaluation
  • Having comorbid conditions that may affect quality of life, including congestive heart failure, chronic kidney disease, chronic liver disease, pulmonary disease, uncontrolled diabetes mellitus, or peripheral vascular disease
  • Having a diagnosis of hypothyroidism or hyperthyroidism
  • Having substance use disorder or alcohol use disorder

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

Turkey (Türkiye) · 1 центр
  • Sultan 1. Murat State Hospital — Edirne

Идентификаторы

NCT: NCT07327775 · 26/11/2025-12/03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗