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临床试验/NCT07846501
NCT07846501Enrolling By Invitation不适用

The Role of Pain Catastrophizing, Resilience, and Illness Perception in Predicting Fibromyalgia Impact in Patients With Fibromyalgia

Bilecik Seyh Edebali Universitesi1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
150
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

This study aims to reveal the effects of pain catastrophizing, psychological resilience, and illness perception on the impact level of fibromyalgia in patients with fibromyalgia, to determine the predictive power of these psychosocial variables regarding the impact level of fibromyalgia, and to evaluate their roles in explaining the burden of the disease.

详细描述

While pain catastrophizing, resilience, and illness perception have been examined separately in patients with fibromyalgia, studies evaluating the extent to which these variables collectively predict the impact of the disease are limited. Addressing pain catastrophizing and negative illness perception as risk factors, alongside resilience as a protective factor, within a single model will contribute to a more holistic explanation of the disease burden experienced by fibromyalgia patients. The results of this study are expected to enhance the understanding of the psychosocial factors that determine the impact of the disease on fibromyalgia patients. Furthermore, the findings are anticipated to provide a scientific basis for the development of psychoeducation, cognitive-behavioral counseling, resilience-supporting interventions, and individualized care plans by nurses and other healthcare professionals. In this regard, the study will contribute to strengthening the biopsychosocial approach to fibromyalgia management and to the planning of patient-centered care practices.

研究设计

研究类型
Observational
观察模型
Other
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
否

入选标准

  • •Patients diagnosed with fibromyalgia,
  • •Aged 18 years or older,
  • •Literate in Turkish,
  • •And without communication difficulties.

排除标准

  • •Those with a disease causing cognitive impairment who are unable to answer the survey questions,
  • •Those with chronic painful medical conditions other than fibromyalgia (e.g., migraine, diabetic neuropathy, rheumatoid arthritis, etc.),
  • •Those diagnosed with neurocognitive, mental, or emotional disorders,
  • •Patients with multisystemic diseases such as cancer.

结局指标

主要结局

Visual Analog Scale

时间窗: 1 days

VAS (Visual Analog Scale): A scale consisting of a 10 cm horizontal line marked at equal intervals, with one end representing "no pain" and the other "unbearable pain." The patient is asked to mark the point on the line that best represents the intensity of their pain. This distance, measured in millimeters, is interpreted as a "score." Regarding pain intensity, a score of 0 is rated as "no pain," while a score of 10 is rated as "unbearable, worst possible pain."

Revised Fibromyalgia Impact Questionnaire

时间窗: 1 days

Revised Fibromyalgia Impact Questionnaire (FIQR): This questionnaire was updated by Bennett et al. in 2009. It consists of 21 separate questions, all rated on a scale of 0 to 10; a score of 10 represents the worst possible state, while 0 indicates the absence of the complaint. The questionnaire comprises three sub-dimensions: "function" (9 questions), "overall impact" (2 questions), and "symptoms" (10 questions). The total score for function (range 0-90) is divided by 3, the total score for overall impact (range 0-20) remains unchanged, and the total score for symptoms (range 0-100) is divided by 2. The total questionnaire score (0-100) is the sum of these values. A higher score indicates a high level of impact from the disease. The recommended cut-off points for disease severity are as follows: 0-23, remission; 24-40, mild disease; 41-63, moderate disease; 64-82, severe disease; and 83-100, very severe disease. The Cronbach's alpha for the FIQR is 0.95, and item-total correlations ra

The Pain Catastrophizing Scale

时间窗: 1 days

The Pain Catastrophizing Scale is a 13-item self-report scale developed by Sullivan et al. to assess the extent to which individuals tend to catastrophize in response to pain; it utilizes a 5-point Likert-type rating system (scoring 0-4). The original form of the scale comprises three sub-dimensions: helplessness, magnification, and rumination. The internal consistency reliability of the Turkish adaptation of the Pain Catastrophizing Scale was found to be very high, with a Cronbach's alpha coefficient of 0.955. Item-total and inter-item correlation coefficients for the scale were determined to range between 0.488 and 0.848.

Brief Illness Perception Questionnaire

时间窗: 1 days

Brief Illness Perception Questionnaire: Developed by Broadbent et al. in 2006. This scale comprises 8 items plus an additional item investigating causal factors. With the exception of the ninth item regarding causal factors, the eight items on the scale use a Likert-type scoring system ranging from 0 to 10. The first five items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two items assess emotional illness perceptions: concern (Item 6) and emotions (Item 8). One item evaluates illness coherence (Item 7). Causal representation is assessed via an open-ended question asking patients to list the most important causal factors of their illness (Item 9). Scores on the scale indicate the perceived threat of the illness or the individual's level of ease regarding the condition. When calculating the score, the values for items 3, 4, and 7 are reversed and added to the scores of

Brief Resilience Scale

时间窗: 1 days

Brief Resilience Scale: This scale was developed by Smith et al. (2008) to measure individuals' psychological resilience. It is a 6-item, self-report instrument using a 5-point Likert scale. Items 2, 4, and 6 are reverse-coded. After reversing the scores for these items, high total scores indicate a high level of psychological resilience. The internal consistency reliability of the Turkish adaptation of the scale was found to be .83.

次要结局

未报告次要终点

研究者

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

Semanur Bilgiç

Research Assistant

Bilecik Seyh Edebali Universitesi

研究点 (1)

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