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

January 8, 2026 updated by: Alper Mengi, Sultan 1. Murat State Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mothers have children with Attention-Deficit/Hyperactivity Disorder
Mothers with Fibromyalgia Syndrome who have children with Attention-Deficit/Hyperactivity Disorder
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 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
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan 1. Murat State Hospital

Investigators

  • Principal Investigator: İbrahim Tiryaki, MD, Sultan 1. Murat State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Estimated)

January 8, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26/11/2025-12/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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