Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 5
- 主要终点
- Life events calculated over the year preceding the onset of PR symptoms
研究概览
简要总结
Rheumatoid Arthritis (RA) is an inflammatory rheumatic disease that can lead to structural damage and handicap. The RA physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the RA mechanism, and improves the diagnosis and the treatment of the disease.
详细描述
The physiopathology of RA is multifactorial, implicating genetic and environmental factors. Within the environmental factors, the exact role of psychological stress and life events on the onset of the disease is still under question. In clinical practice, patients usually report the occurrence of a stressing life event before the diagnosis of the disease (mourning, dismissal, divorce...). Nevertheless, literature reviews present some discrepancies and did not lead to a clear identification of the role of psychological stress in RA onset. This is mainly due to the evaluation methods of stress within those previous studies, considering stress as a unique response of the organism without taking into account personal, sociological, biological or environmental history. The aim of the study is to analyze the impact of stress on the RA onset within an integrative model, to evaluate patient assessment of the stress, and to present strategies to fix it.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 aged over 18 years old
- •patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years.
- •Speaking and understanding French language
- •Being informed about the study and having given his oral consent
排除标准
- •Pregnant or breastfeeding women
- •Patient who refuse to participate.
- •Inclusion Criteria:
- •patients aged over 18 years old
- •patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration...)
- •Speaking and understanding French language
- •Being informed about the study and having given his oral consent
- •Exclusion Criteria:
- •Pregnant or breastfeeding women
- •Patient who refuse to participate
结局指标
主要结局
Life events calculated over the year preceding the onset of PR symptoms
时间窗: At inclusion (day 0)
Social Readjustment Rating Scale (SRRS)
次要结局
- Cytokine levels in RA patients sera(12 months from baseline)
- Perceived stress(At inclusion (day 0))
- Perceived social support(At inclusion (day 0))
- Perceived control(At inclusion (day 0))
- State Anxiety(At inclusion (day 0))
- Coping(At inclusion (day 0))
- Correlation between cytokine levels and RA activity(12 months from baseline)
- Correlation between cytokine levels and stress for RA patients(12 months from baseline)
- Identification of neuropathic pain for RA patients evalued by douleur-neuropathique 10 items questionnaire(12 months from baseline)
- Characterization of neuropathic pain for RA patients evalued by Neuropathic Pain Symptom Inventory questionnaire(12 months from baseline)