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NCT Number: NCT07327775

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

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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Key information

Conditions

Fibromyalgia Syndrome Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Attention-Deficit/Hyperactivity Disorder Disease Burden Fibromyalgia Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurodevelopmental Disorders Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disease Burden

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.

Primary outcomes

  1. pain severity

    Time frame: Baseline

    Pain intensity in all patients will be assessed using the Visual Analog Scale (VAS). For the VAS assessment, a 10-cm horizontal straight line will be used, where 0 indicates no pain and 10 indicates unbearable pain. The average pain intensity experienced during the previous week will be recorded using the VAS.

  2. quality of life and functional status

    Time frame: Baseline

    To assess quality of life and functional status in patients, the Fibromyalgia Impact Questionnaire (FIQ), which has demonstrated validity and reliability in Turkish, will be used. This questionnaire evaluates 10 domains: physical functioning, overall well-being, work absenteeism, work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The maximum possible score is 100, with higher scores indicating greater functional impairment.

  3. level of central sensitization

    Time frame: Baseline

    Patients' levels of central sensitization will be assessed using the Central Sensitization Inventory (CSI), which has demonstrated validity and reliability in Turkish. The CSI consists of 25 items, each scored on a 5-point Likert scale ranging from 0 to 4. A total score of 40 or higher indicates the presence of central sensitization.

Study contacts

Contact information is provided by the study sponsor or research team.

Alper Mengi, MD

CONTACT

[email protected]

+90 537 651 03 85

Sponsors and collaborators

Lead sponsor

Sultan 1. Murat State Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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