Fibromyalgia Disease Burden in Mothers of Children With Attention-Deficit/Hyperactivity Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorSultan 1. Murat State Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Disease Burden
Other interventionThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Mothers have children with Attention-Deficit/Hyperactivity Disorder1 intervention
Group B: Mothershave children without psychiatric disorders1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov