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Evaluation of Stigma and Related Factors in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04274036
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital

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.

Condition or disease
Fibromyalgia

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.

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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Stigma and Related Factors in Fibromyalgia Patients
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Group/Cohort
Fibromyalgia Patients
Fibromyalgia patients diagnosed according to the 2016 American College of Rheumatology criteria.
Healthy-Controls
Healthy controls without pain or chronic illness



Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: Baseline ]
    A scale to measure pain which "0" shows no pain and "10" shows worst pain ever

  2. 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.

  3. 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

  4. 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'.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Fibromiyalgia patients and healthy controls with an allocation ratio of 2:1.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274036


Contacts
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Contact: Mehmet Akif Guler, M.D. +905054930098 makifguler89@gmail.com

Locations
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Turkey
Gaziosmanpasa Taksim Research and Education Hospital Recruiting
Istanbul, Turkey
Contact: Mehmet Akif Güler, Dr.    +905054930098    makifguler89@gmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital
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Responsible Party: Mehmet Akif GÜLER, Principal Investigator, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT04274036    
Other Study ID Numbers: 13
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital:
Fibromyalgia
Social Support
Stigma
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases