Fibromyalgia SyndromeNCT07327775
Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit/Hyperactivity Disorder
An observational study of Fibromyalgia Syndrome and Disease Burden, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome, Disease Burden, Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Disease Burden
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2025to 30 Apr 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan 1. Murat State Hospital
Edirne, 22030
Alper Mengi, +90 5537 651 03 85, dralpmengi@gmail.com
About this study
Official title: 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.
Read more
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.
- Being tested
- Disease Burden
- Medical subject headings
- Fibromyalgia, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease BurdenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mothers have children with Attention-Deficit/Hyperactivity Disorder | Mothers with Fibromyalgia Syndrome who have children with Attention-Deficit/Hyperactivity Disorder Receives: Other: Disease Burden | |
| Mothershave children without psychiatric disorders | Mothers with Fibromyalgia Syndrome who have children without psychiatric disorders Receives: Other: Disease Burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start26 Dec 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sultan 1. Murat State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alper Mengi, Sultan 1. Murat State Hospital
- Investigators
- İbrahim Tiryaki, MD, Principal investigator, Sultan 1. Murat State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327775
- Sponsor's protocol ID
- 26/11/2025-12/03
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Disease Burden of Fibromyalgia Syndrome Higher in Mothers of Children With Attention-Deficit/Hyperactivity Disorder? A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07327775
- Acronym / sponsor ID
- 26/11/2025-12/03
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sultan 1. Murat State HospitalOther government
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers have children with Attention-Deficit/Hyperactivity Disorder | – | Other: Disease BurdenMothers with Fibromyalgia Syndrome who have children with Attention-Deficit/Hyperactivity Disorder |
| Mothershave children without psychiatric disorders | – | Other: Disease BurdenMothers with Fibromyalgia Syndrome who have children without psychiatric disorders |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease BurdenThe 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. | Other | Mothers have children with Attention-Deficit/Hyperactivity Disorder, Mothershave children without psychiatric disorders |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
İbrahim Tiryaki, MD principal investigator
Sultan 1. Murat State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia Syndrome and Disease Burden, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alper Mengi, MD (+90 537 651 03 85, a_mengi22@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.