Effect of raising a child with ADHD on mothers' fibromyalgia burden
Is the Disease Burden of Fibromyalgia Syndrome Higher in Mothers of Children With Attention-Deficit/Hyperactivity Disorder? A Prospective Controlled Study
We will see if mothers aged 18–50 who have fibromyalgia and a child with ADHD have more disease burden than mothers with fibromyalgia whose children do not have psychiatric disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Sultan 1. Murat State Hospital Government |
| Locations | 1 site (Edirne) |
| Trial ID | NCT07327775 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll 50 mothers with fibromyalgia who have a child diagnosed with ADHD and 50 mothers with fibromyalgia whose children have no psychiatric disorders. Mothers followed at the Child and Adolescent Psychiatry Outpatient Clinic who report widespread body pain will be referred to the hospital's Pain Management Outpatient Clinic for confirmation of fibromyalgia using 2016 ACR criteria. The comparison group will be selected from patients already diagnosed with fibromyalgia who have children without psychiatric disorders. Clinical evaluations and questionnaires will be used to compare disease burden and pain-related outcomes between the two groups.
Who should consider this trial
Good fit: Women aged 18–50 with a diagnosis of fibromyalgia and at least one child aged 6–17—either with a DSM-5 diagnosis of ADHD (study group) or without any psychiatric disorder (comparison group)—who are literate and can attend clinic visits.
Not a fit: Women receiving regular pharmacological treatment for fibromyalgia, those with active psychiatric disorders or using psychiatric medications, those with recent infectious or chronic inflammatory diseases, or those outside the 18–50 age range are unlikely to be eligible or to receive benefit from participation.
Why it matters
Potential benefit: If successful, the study could reveal whether caregiving for a child with ADHD is linked to greater fibromyalgia burden and inform targeted support or interventions for affected mothers.
How similar studies have performed: Some prior research links caregiver stress to worse pain and fatigue, but directly comparing mothers with fibromyalgia based on their child's ADHD status is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edirne
- Sultan 1. Murat State Hospital — Edirne, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: İbrahim Tiryaki, MD — Sultan 1. Murat State Hospital
- Study coordinator: Alper Mengi, MD
- Email: a_mengi22@hotmail.com
- Phone: +90 537 651 03 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.