Mindfulness-based Stress Reduction or Usual Treatment for Treatment of Chronic Pain in an Italian Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Chronic pain assessed with the Brief Pain Inventory (BPI)
研究概览
简要总结
Mindfulness-Based Cognitive Therapy (MBCT) combines ideas of traditional cognitive therapies with meditative practices aimed at cultivating mindfulness. Mindfulness-based stress reduction (MBSR) is considered one of the original mindfulness-based interventions. It has been modified to be offered virtually,which has been useful throughout the COVID pandemic, and more importantly, has served to inform other mindfulness approaches, such as trauma-focused therapy. The investigators want to assess the efficacy of MBSR in patients with Chronic Pain undergoing drug treatment.
详细描述
Mindfulness helps develop the ability to observe and detach from our mental, sensory, and emotional states, and thus increases our awareness and ability to manage emotions.
In the experimental arm, some have been foreseen group sessions, in which a maximum of ten people participate on the Mindfulness-based stress reduction (MBSR).
The protocol provides for eight meetings (one and a half or two hours each) on a monthly basis, for a total duration, therefore, of twelve months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients being treated for Chronic Pain
- •Patients with Chronic Pain in Pharmacological Therapy
排除标准
- •Patients with Chronic Pain not in Pharmacological Therapy
- •Patients without Chronic Pain
结局指标
主要结局
Chronic pain assessed with the Brief Pain Inventory (BPI)
时间窗: 1 year
Chronic or persistent pain is pain that carries on for longer than 12 weeks despite medication or treatment.
次要结局
- Drug assumption(1 year)
- Quality of life assessore with EQ5D(1 year)
研究者
Vincenzo Damico
Principal Investigator: Vincenzo Damico, Registered Nurse, Doctor of Philosophy, Department of Anesthesia and Critical Care, Azienda Socio Sanitaria Territoriale of Lecco
Azienda Socio Sanitaria Territoriale di Lecco