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Clinical Trials/NCT04274036
NCT04274036
Unknown
N/A

Evaluation of Stigma and Related Factors in Fibromyalgia Patients

Gaziosmanpasa Research and Education Hospital1 site in 1 country108 target enrollmentFebruary 13, 2020
ConditionsFibromyalgia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
Gaziosmanpasa Research and Education Hospital
Enrollment
108
Locations
1
Primary Endpoint
Visual Analog Scale
Last Updated
6 years ago

Overview

Brief Summary

Stigmatization is especially studied in mental disorders such as schizophrenia. In recent years, different chronic diseases such as AIDS, tuberculosis, and diabetes have also been shown to decrease in quality of life due to the "stigma" of these patients.

Detailed Description

Stigmatization is especially studied in mental disorders such as schizophrenia. In recent years, different chronic diseases such as AIDS, tuberculosis, and diabetes have also been shown to decrease in quality of life due to the "stigma" of these patients. Fibromyalgia patients with chronic widespread body pain and accompanying subjective fatigue, depression, and anxiety; Although there is no objective pathology from the outside, it can be stigmatized in family life, work-life and health institutions they apply for the diagnosis of pain due to the intensive complaints. The fact that the subjective complaints seen without an objective pathology are so severe makes the management of these patients difficult. To reveal the presence of stigma in patients diagnosed with fibromyalgia compared with the healthy control group is the main aim of this study. It is the secondary purpose of this study to determine related factors such as gender, age, educational status, marital status, employment status, income level, pain duration, pain intensity, medications used, and social support received from patients' family and the environment. We hypothesize that this group of patients suffers more stigma and the quality of life decreases due to this stigma.

Registry
clinicaltrials.gov
Start Date
February 13, 2020
End Date
May 31, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mehmet Akif GÜLER

Principal Investigator

Gaziosmanpasa Research and Education Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients over the age of 18
  • To be diagnosed with fibromyalgia according to American College of Rheumatology 2016 revised criteria

Exclusion Criteria

  • Have been diagnosed and treated with fibromyalgia before
  • Presence of any diagnosis that can cause secondary fibromyalgia (rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis)
  • The presence of anemia
  • Vitamin D deficiency
  • Presence of known endocrine, neurological and cardiac diseases
  • Antidepressant use

Outcomes

Primary Outcomes

Visual Analog Scale

Time Frame: Baseline

A scale to measure pain which "0" shows no pain and "10" shows worst pain ever

Discomfort Intolerance Scale

Time Frame: Baseline

The Discomfort Intolerance Scale is brief, self-report index of the degree to which individuals tolerate physical discomfort including pain. Items for this scale were developed by experts in pain and anxiety. Participants rate the questions on a scale ranging from 0 (not at all like me) to 6 (extremely like me). Higher points show worst outcomes.

The Distress Tolerance Scale

Time Frame: Baseline

Distress tolerance is defined as the capacity to experience and withstand negative psychological states. Distress may be the result of cognitive or physical processes but manifests in an emotional state often characterized by action tendencies to alleviate the emotional experience. Distress tolerance is considered a meta-emotion construct that consists of one's evaluations and expectations of experiencing negative emotional states in respect to tolerability and aversiveness, appraisal and acceptability, tendency to absorb attention and disrupt functioning, and regulation of emotions, specifically, the consequent strength of action tendencies to either avoid or immediately attenuate the experience

Fibromyalgia Impact Questionnaire - Revised

Time Frame: Baseline

The revised Fibromyalgia Impact Questionnaire has 21 individual questions All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

Stigma Scale for Chronic Illness

Time Frame: Baseline

The stigma scale consists of 24 items. Item scores range from 1 (never) to 5 (always). A summary index is calculated by adding all scores, ranging from 24 to 120, with higher scores reflecting the worst stigmatization.

Study Sites (1)

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