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临床试验/NCT03964285
NCT03964285已完成不适用

Impact of Rumination on Affectivity After Physical Activity in Fibromyalgia

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Change in PANAS score before and after induction phase

研究概览

简要总结

Some fibromyalgia patients may use inappropriate emotional regulation strategies to respond to pain. Rumination could be one of this inefficient regulation strategies. The investigators believe that the use of rumination strategies to respond to the discomfort of daily physical activity would maintain and aggravate a negative emotional state after the effort. Distraction would be a more effective strategy to cope with pain. From this data, the investigators want to explore the causal link between rumination and negative affectivity after physical activity in fibromyalgia using an experimental design.

详细描述

Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. As with any condition of chronic pain, psychological mechanisms can help maintain discomfort and pain. These mechanisms may hinder the recovery of physical activity. Some patients may use cognitive strategies of emotional regulation that are ineffective to cope with pain and discomfort of everyday activities, such as rumination. The literature suggests that this process is linked to the physical and psychological difficulties of fibromyalgia. However, no study has revealed a causal link between rumination and negative affectivity in a context of physical activity in this population. The investigators want to test this hypothesis by directly manipulating the style of information processing following a relevant activity for these patients: climbing steps. In one group the investigators will induce rumination right after climbing the steps. In the other group the investigators will induce distraction. Patient with Fibromyalgia will be recruited at the Pain Center of CHU-Amiens. Patients will complete different scales before to climb steps and after experimental induction. The investigators hypothesize that Patients using a rumination strategy after an uncomfortable physical activity will experience a greater subjective discomfort than patients using a distraction strategy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • •Adults Patients
  • •Free and informed consent signed.
  • •French native speaker, writer and reader.
  • •according 1990 American College of Rheumatology criteria : Patients with diffuse pain for more than three months and with digital palpation pain on more than 11 insertion points.

排除标准

  • •minor patients
  • •Adult major under administrative protection
  • •Patient with severe psychosis or depression or severe anxiety or impulsivity as assessed by the clinician

研究组 & 干预措施

Rumination group

Active Comparator

The patients will receive rumination induction. Rumination induction will follow a relevant activity for our patients: climbing steps. Rumination induction will be done right after climbing the steps.

干预措施: rumination induction (Other)

distraction group

Experimental

Distraction will follow a relevant activity for our patients: climbing steps. Distraction induction will be done right after climbing the steps.

干预措施: distraction induction (Other)

结局指标

主要结局

Change in PANAS score before and after induction phase

时间窗: One hour and twenty minutes after inclusion of the patients

The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. The list is split up into two segments, or mood scales. One scale measures a person's positive emotion and the other scale measures the negative. Each segment has ten terms, which can be rated on a scale of 1 to 5 to indicate the extent to which the respondent agrees that this applies to him.Characteristic of this test is the fact that it can be completed in 10 minutes. High score is associated with stress and anxiety. small score is associated with calm.

次要结局

  • Change in VAS score before and after induction phase(One hour and twenty minutes after inclusion of the patients)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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