Beneficial Effects of Self-hypnosis/Self-care Learning Program for Chronic Pain Patients : a MRI and EEG Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in pain description
研究概览
简要总结
Chronic pain concerns one in four adults in Belgium. Fibromyalgia is an example of chronic pain and is characterized by diffused and migrant musculo-tendinous pain localized in the limbs and at an axial level. The technological improvement in neuroimaging allowed to improve, at a cerebral level, the identification of the structural and the functional characteristics of this clinical entity. Studies indicated a modification in cerebral morphometry showing an alteration of white and grey matter in the anterior cingulate cortex, orbitofrontal lateral cortex, cerebellum, basal ganglia, insula, secondary somatosensory cortex, thalamus, amygdala, putamen, superior temporal gyrus and periaqueductal grey matter. At a functional level, studies show un alteration in the connectivity of the default mode network, an atrophy of zones implicated in nociception and an increased activation of zone implicated in response to a nociceptive stimulus.
Nowadays, researchers are interested in finding out the beneficial effects of non-pharmacological techniques to improve de well-being of patients with chronic pain. Hypnosis is one of these techniques that has already proven to be successful in decreasing pain and improving global quality of life. Nevertheless, to our knowledge, no study has been conducted to understand the impact of hypnosis upon the cerebral functioning of these patients. Therefore, the aim of this study is to understand the impact of a 6 months self-hypnosis/self-care learning program upon the structural and functional functioning of the brain by means of functional magnetic resonance imagery (fMRI) and electroencephalography (EEG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Fluency in French
- •Fibromyalgia diagnosis
排除标准
- •Neurologic disorder
- •Psychiatric disorder
- •Drug addiction
- •Alcoholism
结局指标
主要结局
Change in pain description
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on pain description will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).
Change in pain disability
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on pain disability will be assessed by means of the "Pain Disability Index" (PDI, Tait et al., 1990). Scale ranging from 0 (no difficulties) to 10 (a lot of difficulties).
Change in health status
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of Self-hypnosis/self-care on global health status will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (worst health status) to 100 (best health status).
Change in quality of life
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the quality of life will be assessed by means of the "Short Form-36"(SF-36; Ware et al., 1988). Each item is balanced to obtain a score between 0 (worst quality) to 100 (maximum quality).
Change in sleep difficulties
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care upon the severity of insomnia will be assessed by means of the "Insomnia Severity Index" (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).
Change in locus of control
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the locus of control will be assessed my means og the "Multidimensional Health Locus of Control" (MHLC, Wallston et al., 1978). Scale ranging from 1 (no agreement) to 4 (agreement).
Change in anxiety
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on anxiety will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).
Change in depression
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on depression will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).
Change in attitudes and beliefs about pain
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the attitudes and beliefs about pain will be assessed my means of the "Survey of Pain Attitudes" (SOPA, Jensen \& Karoly, 1987). Scale ranging from 0 (totally wrong) to 10 (totally right).
Change of the impact of pain
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the impact of pain in individual's life, quality of social support and general activity, will be assessed my means of the "Multidimensional Pain Index" (PDI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).
Change in generic health
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on generic health will be assessed by the "EuroQol 5 Dimensions" questionnaire (EQ-5D, Health Policy, 1990). Scale ranging from 1 (no problems) to 3 (extreme problems).
Change in physical activity
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the physical activity will be assessed by means of the International Physical Activity Questionnaire (Craig et al., 2003). Participants have to describe the amount of low to intense physical activity they did over a period of 7 days.
Motivation to change
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the motivation to change will be assessed by means of the "University of Rhode Island Change Assessment" (URICA, DiClemente et al., 1990). Scale ranging from 1 (no agreement) to 5 (agreement).
Impact on return-to-work
时间窗: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
For participants who continued to work at time of inclusion, the "Work Design Questionnaire" (WDQ, Morgeson \& Hymphrey, 2006) will be administered. Scale ranging from 0 (not at all) to 5 (exactly).
次要结局
未报告次要终点
研究者
Audrey Vanhaudenhuyse
Principal Investigator
University of Liege