Evaluation of Stigma and Related Factors in Fibromyalgia
1 other identifier
observational
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2020
CompletedStudy Start
First participant enrolled
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedFebruary 18, 2020
February 1, 2020
4 months
February 13, 2020
February 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Visual Analog Scale
A scale to measure pain which "0" shows no pain and "10" shows worst pain ever
Baseline
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
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
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
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
Study Arms (2)
Fibromyalgia Patients
Fibromyalgia patients diagnosed according to the 2016 American College of Rheumatology criteria.
Healthy-Controls
Healthy controls without pain or chronic illness
Eligibility Criteria
Fibromiyalgia patients and healthy controls with an allocation ratio of 2:1.
You may qualify if:
- Patients over the age of 18
- To be diagnosed with fibromyalgia according to American College of Rheumatology 2016 revised criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 18, 2020
Study Start
February 13, 2020
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
February 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share