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

NCT07327775 | Recruiting

• 1 other identifier: 26/11/2025-12/03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention-Deficit/Hyperactivity Disorder; Fibromyalgia Syndrome; Disease Burden

Outcome Measures

Primary Outcomes (3)

• pain severity

  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.

  Baseline

• quality of life and functional status

  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.

  Baseline

• level of central sensitization

  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.

  Baseline

Study Arms (2)

Mothers have children with Attention-Deficit/Hyperactivity Disorder

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

Other: Disease Burden

Mothershave children without psychiatric disorders

Mothers with Fibromyalgia Syndrome who have children without psychiatric disorders

Other: Disease Burden

Interventions

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.

Mothers have children with Attention-Deficit/Hyperactivity Disorder; Mothershave children without psychiatric disorders

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan 1. Murat State Hospital: lead

Study Sites (1)

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Attention Deficit Disorder with Hyperactivity

Interventions

Cost of Illness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Costs and Cost Analysis; Economics; Health Care Economics and Organizations; Health Status Indicators; Health Surveys; Surveys and Questionnaires; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Methods; Public Health; Environment and Public Health

Study Officials

• İbrahim Tiryaki, MD

  Sultan 1. Murat State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alper Mengi, MD

CONTACT

+90 537 651 03 85; a_mengi22@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: December 26, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)