Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit/Hyperactivity Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Disease Burden.
- Who it may be relevant to
- Registry conditions: Fibromyalgia Syndrome, Disease Burden, Attention-Deficit/Hyperactivity Disorder. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Is the Disease Burden of Fibromyalgia Syndrome Higher in Mothers of Children With Attention-Deficit/Hyperactivity Disorder? A Prospective Controlled Study
Overview
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.
Interventions
- Other 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
Primary outcome measures
- pain severity [Time frame: Baseline]
- quality of life and functional status [Time frame: Baseline]
- level of central sensitization [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Turkey (Türkiye) · 1 center
- Sultan 1. Murat State Hospital — Edirne
Identifiers
NCT: NCT07327775 · 26/11/2025-12/03