- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274036
Evaluation of Stigma and Related Factors in Fibromyalgia
February 16, 2020 updated by: Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
Evaluation of Stigma and Related Factors in Fibromyalgia Patients
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mehmet Akif Guler, M.D.
- Phone Number: +905054930098
- Email: makifguler89@gmail.com
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Gaziosmanpasa Taksim Research and Education Hospital
-
Contact:
- Mehmet Akif Güler, Dr.
- Phone Number: +905054930098
- Email: makifguler89@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Fibromiyalgia patients and healthy controls with an allocation ratio of 2:1.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: Baseline
|
A scale to measure pain which "0" shows no pain and "10" shows worst pain ever
|
Baseline
|
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.
|
Baseline
|
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
|
Baseline
|
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'.
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2020
Primary Completion (Anticipated)
May 31, 2020
Study Completion (Anticipated)
May 31, 2020
Study Registration Dates
First Submitted
February 13, 2020
First Submitted That Met QC Criteria
February 16, 2020
First Posted (Actual)
February 18, 2020
Study Record Updates
Last Update Posted (Actual)
February 18, 2020
Last Update Submitted That Met QC Criteria
February 16, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
University of AberdeenCompletedFibromyalgia | Fibromyalgia, Primary | Fibromyalgia, SecondaryUnited Kingdom
-
Eli Lilly and CompanyCompletedFibromyalgia, Primary | Fibromyalgia, SecondaryMexico
-
Rasmia ElgoharyNot yet recruiting
-
Spaulding Rehabilitation HospitalNot yet recruiting
-
Cairo UniversityNot yet recruiting
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
University of UtahTerminated
-
State University of New York - Upstate Medical...CompletedFibromyalgia, PrimaryUnited States
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Tel-Aviv Sourasky Medical CenterCompletedFibromyalgia (FM)Israel