Clinical trial NCT06777667: Fibromyalgia Severity: Role of Resilience and Family Dynamics
Official title: Impact of Resilience and Family Dynamics on Disease Severity in Women With Fibromyalgia: Comparison With Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Resilience
Keywords: Fibromyalgia
Connor-Davidson Resilience Scale
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-16
Enrollment: 194
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult females aged 25-45 years. Participants will be divided into two groups: (1) individuals with a diagnosis of fibromyalgia and (2) healthy female controls within the same age range. All participants will be recruited through convenience sampling, such as patients visiting the Physical Medicine and Rehabilitation Clinic at Antalya City Hospital, and will provide written informed consent.

Brief summary: This cross-sectional survey study aims to examine the resilience and family dynamics between newly diagnosed fibromyalgia (FM) patients and healthy individuals. The study will analyze demographic data including parental attitude and childhood trauma and resilience levels using the Connor-Davidson Resilience Scale (CD-RISC-10) in fibromyalgia patients and healthy controls. The Revised Fibromyalgia Impact Questionnaire (FIQR) will also be administered to FM patients to determine the total impact and severity of the disease (mild, moderate, severe, very severe). In addition to aiming to reveal how FM patients compare to healthy individuals in terms of resilience and parental attitude, this study will also examine the relationship between disease severity and these psychosocial variables. As a result, the data obtained are expected to reveal both potential differences in resilience and family problems in FM patients and the relationship of these factors with disease severity.

Detailed description: FM is a common disease worldwide, characterized by chronic widespread pain, sleep problems, physical fatigue, and cognitive difficulties. It is estimated that symptoms are seen in around 2-4% of the population. Although FM is due to a complex disease model triggered by biological and psychosocial variables, the details are still unclear.

While psychological resilience plays a critical role in coping with stress and chronic pain, a supportive family environment can contribute to individuals developing effective coping mechanisms. Research shows that low resilience levels can trigger FM and a controlling family environment can negatively affect emotional functioning.

The increase in the incidence of FM in recent years has placed additional burdens on the healthcare system. Therefore, it is necessary to provide new perspectives that will guide clinicians who face FM and contribute to improving treatment processes.

The research aims to develop a deep understanding of the etiology and course of FM, as well as to contribute to customizing individual treatment approaches and health services by revealing the effects of psychosocial factors. This study will contribute to the understanding of the relationships between psychological resilience, family dynamics and disease severity in fibromyalgia patients. The data to be obtained will help develop new perspectives and suggestions for clinical practices by emphasizing the importance of psychological support and family dynamics in the treatment processes of fibromyalgia. In addition, comparisons with healthy controls may lead to a better understanding of the needs of individuals with FM. Another important benefit expected from the study is to place more emphasis on the importance of resilience and problems in child development. These studies have the potential to reduce the risks of developing FM and similar diseases in tomorrow's adults. In this context, primary prevention strategies may contribute to public health and the burden on the health system.

This study aims to examine the relationships between psychological resilience, childhood problems and severity of fibromyalgia symptoms between FM patients and healthy control groups. In particular, it was aimed to determine which elements significantly affect symptom severity by evaluating the effects of these factors on FM.

The hypotheses of the study:

Hypothesis 1: Individuals with low psychological resilience and a negative parental attitude during childhood will experience more severe FM symptoms.

Hypothesis 2: FM patients will have lower psychological resilience and more negative parental attitude compared to healthy controls.

Rationale for the study:

FM is a common disease characterized by chronic widespread pain, sleep problems, physical fatigue, and cognitive difficulties. It is characterized by chronic widespread pain, somatic symptoms, and cognitive difficulties. FM is seen in all populations worldwide, and the prevalence of symptoms varies between 2% and 4% in the general population. A model has been proposed for the pathogenesis of FM in which biological and psychosocial variables influence the susceptibility, triggering, and worsening of a chronic disease, but the details are unclear.

FM is a complex and multifactorial disorder, and the severity of its symptoms may be affected by the individual's psychosocial circumstances. While psychological resilience plays a critical role in coping with chronic pain and stress, a supportive family environment may encourage individuals to develop effective coping mechanisms. There may be a link between FM and resilience, as resilience is closely related to an individual's response to acute or chronic stress, which can affect chronic pain conditions such as FM. Resilience is a complex structure that is contributed by genetics and environmental factors, and in some individuals, these factors may help to develop a personality that is more resilient to stressful life events. Therefore, low resilience may be a trigger for FM. The family environment may also be a factor contributing to the complex structure of fibromyalgia. Previous research has found that a controlling (highly regimented and less independent) family environment in early adolescence is a key factor predicting poorer long-term emotional functioning in juvenile FM patients. Reports indicate that the incidence of fibromyalgia increased from 2001 to 2013, suggesting that the healthcare system will be further burdened by the management of this disease. This study will provide important guidance for clinicians facing FM and will help to provide new perspectives on the management of the disease.

This study aims to better understand the potential contributions and effects of these factors on the health of individuals by examining the effects of psychological resilience and family environment on the severity of fibromyalgia. The findings to be obtained in these areas may contribute to the development of individual treatment approaches and the customization of health services.

This study will provide data that can help improve treatment processes by developing a deeper understanding of the etiology and course of FM. In addition, understanding the role of psychosocial and environmental factors will allow the development of more targeted interventions for clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Age range: Women between the ages of 25-45.
2. Diagnosis: For fibromyalgia Group: Individuals diagnosed according to the 2016 revision of the American College of Rheumatology's 2010/2011 fibromyalgia diagnostic criteria. For healthy Control Group: Healthy women without a fibromyalgia diagnosis.
3. Consent: Individuals who volunteered to participate in the research processes and gave informed consent regarding the details of participation and signed the consent form.

Exclusion Criteria:

1. Serious medical conditions: Individuals with serious health problems such as autoimmune diseases, cancer, severe heart and lung diseases, or acute pain caused by trauma, surgery, inflammatory joint diseases, etc.
2. Psychiatric conditions: Individuals with psychiatric diseases, medication use, or whose mental state may affect their ability to understand and complete the survey questions.

Primary outcomes:
measure: Resilience levels
timeFrame: Baseline/ at the time of enrollment
Secondary outcomes:
measure: Correlation between resilience and the severity of fibromyalgia symptoms.
timeFrame: Baseline/ at the time of enrollment
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya City Hospital
Study officials:
affiliation: Physical Medicine and Rehabilitation
name: Zehra Duman Sahin, MD
role: STUDY_CHAIR
References:
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citation: Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
citation: Fowler PC. Factor structure of the Family Environment Scale: effects of social desirability. J Clin Psychol. 1982 Apr;38(2):285-92. doi: 10.1002/1097-4679(198204)38:23.0.co;2-9.