Stress Reduction Program Based on Mindfulness for Patients With Discopathies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Stress change
研究概览
简要总结
This study evaluates the influence of stress on inflammation and the symptomatology of the patient with back pain. Mindfulness Based Stress Reduction (MBSR) will be used in half of participants, a validated psychopedagogical intervention for stress reduction, and the participants assigned to the control group will follow the usual treatment, according to their diagnosis.
详细描述
The Mindfulness based stress reduction (MBSR) is a psycho-educational program of stress reduction based on mindfulness. It consists of a program of 30 hours of duration divided into 9 sessions with a weekly frequency of 2.5 h and an intensive session between the week 6 and 7 of the program with a duration of 7.5 hours. Each week, the theoretical contents that are necessary to understand the attention development practices will be covered. In addition, basic concepts of the psychobiology and psychology of stress and pain will be explained. The subjects will have a homework load of approximately 45 minutes per day during the intervention program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •To be diagnosed with symptomatic disc disease (Participants must provide a medical report that certifies the discopathy).
- •Normal or moderate mobility
- •Normal cognitive state
- •Patients who have previously read and signed the informed consent.
- •Patients that are capable and willing to comply with the study procedures.
排除标准
- •Serious psychopathologies
- •Suicidal thoughts.
- •Deep depression
- •Psychosis
- •Drug addiction
- •Very limited functional capacity and cognitive impairment: Patientsconfined in a bed or a chair. They need the help of a third person.
- •Do not incorporate during the program any clinical, psychological or pharmacological treatments different from those ones that are normally used to controlled the pain, or any drastic changes in lifestyle.
结局指标
主要结局
Stress change
时间窗: Baseline and Six months
Measured with the variation of cortisol in blood. These samples are obtained from a blood test that will be done to the participants before and after starting the experimental and control programs.
Variation of the nocturnal apnea index.
时间窗: Baseline and Six months
Sleep and breathing analysis: The performance of the sleep and breathing registration tests will be carried out in the patient's home. The sleep study will be done with a validated respiratory polygraphy (BTI-APNiA®). The sleep analysis will be controlled by a sleep technician and supervised by a sleep medicine specialist. The sleep analysis will be done to the participants before and after starting the experimental and control programs.
Variation of cytokines
时间窗: Baseline and Six months
((TNF) -α and interleukin (IL) -1β, IL-6 and IL17), as an approximate biomarker of inflammation. Bio-chemical markers of the discopathy: Cytokines ((TNF) -α, interleukin (IL) -1β, IL-6 and IL-17). These samples are obtained from a blood test that will be done to the participants before and after starting the experimental and control programs.
次要结局
- Five Facet Mindfulness Questionnaire (FFMQ)(Baseline and Six months)
- Self-Compassion Scale (SCS)(Baseline and Six months)
- DASS-21(Baseline and Six months)
- Brief Fatigue Inventory (BFI)(Baseline and Six months)
- Pain Coping Inventory (PC)(Baseline and Six months)
- Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)(Baseline and Six months)
- Satisfaction with Life questionnaire (SWLS)(Baseline and Six months)
- Perceived Stress Scale (PSS)(Baseline and Six months)
- Brief Pain Inventory (BPI)(Baseline and Six months)
- Survey of Pain Attitudes - Brief (SOPA-B)(Baseline and Six months)
- WHO-5 Well Being Index(Baseline and Six months)
- Pain Catastrophising Scale (PCS)(Baseline and Six months)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline and Six months)
- Pain and Sleep Questionnaire (PSQ)(Baseline and Six months)
- Chronic Pain Grade Scale (CPGS; 90)(Baseline and Six months)
- Short Form-36 Bodily Pain Scale (SF-36 BPS)(Baseline and Six months)