跳至主要内容
临床试验/NCT04274036
NCT04274036Unknown不适用

Evaluation of Stigma and Related Factors in Fibromyalgia Patients

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年2月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
108
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Visual Analog Scale

时间窗: Baseline

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

Discomfort Intolerance Scale

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mehmet Akif GÜLER

Principal Investigator

Gaziosmanpasa Research and Education Hospital

研究点 (1)

Loading locations...

相似试验