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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-26

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia Syndrome Disease Burden Attention-Deficit/Hyperactivity Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Mothers have children with Attention-Deficit/Hyperactivity Disorder

Mothers with Fibromyalgia Syndrome who have children with Attention-Deficit/Hyperactivity Disorder

Disease Burden

Intervention Type OTHER

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 Questionnaire (FIQ), which has demonstrated validity and reliability in Turkish, will be administered.

Levels of central sensitization will be assessed using the Central Sensitization Inventory (CSI), which has been validated and shown to be reliable in Turkish.

Mothershave children without psychiatric disorders

Mothers with Fibromyalgia Syndrome who have children without psychiatric disorders

Disease Burden

Intervention Type OTHER

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 Questionnaire (FIQ), which has demonstrated validity and reliability in Turkish, will be administered.

Levels of central sensitization will be assessed using the Central Sensitization Inventory (CSI), which has been validated and shown to be reliable in Turkish.

Interventions

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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 Questionnaire (FIQ), which has demonstrated validity and reliability in Turkish, will be administered.

Levels of central sensitization will be assessed using the Central Sensitization Inventory (CSI), which has been validated and shown to be reliable in Turkish.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No