Evaluation of Stigma and Related Factors in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Evaluation of Stigma and Related Factors in Fibromyalgia Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274036
• Other study ID #: 13
• Status: Recruiting
• Start date: February 13, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: February 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: Mehmet Akif Guler, M.D.
• Phone: +905054930098
• Email: makifguler89[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Taksim Research and Education Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	A scale to measure pain which "0" shows no pain and "10" shows worst pain ever	Baseline
Primary	Discomfort Intolerance Scale	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.	Baseline
Primary	The Distress Tolerance Scale	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	Baseline
Primary	Fibromyalgia Impact Questionnaire - Revised	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'.	Baseline
Primary	Stigma Scale for Chronic Illness	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.	Baseline