Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change of maximum VAS
研究概览
简要总结
The purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. The patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The results of this study will provide a new strategy of management of the patient's pain.
详细描述
The majority of cystic fibrosis patients have chronic or intermittent pains. These pains have important consequences on the quality of life. Currently, the treatment is essentially pharmacological (essentially paracetamol) but it is not enough in presence of of visual analogue scale (VAS) >4. In the study, the patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The sophrology is a dynamic method of physical and psychical relaxation. This aims are to decrease the pain, to decrease the anxiety and to improve the everyday life. This study will provide a new global strategy of the management of the patients' pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis patients defined by a test sweat and / or 2 pathogenic mutations
- •Patients over 10 years
- •Patients with pain symptoms (VAS> 4) recurrent (> 4 episodes / month) or permanent since more than 6 months
- •Agreement of patients, and parents (for children) for sophrology sessions conducted at home.
- •Patient affiliated to social security
排除标准
- •Transplant patients or placed on a waiting list transplantation
- •Patients had a patient-support by techniques hypnosis or relaxation therapy, during or within 3 months.
- •Patients enrolled in another research interventional protocol.
- •Women without contraception or pregnant.
结局指标
主要结局
Change of maximum VAS
时间窗: 6 months
Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.
次要结局
- VEMS(6 months)
- SaO2(6 months)
- number of paroxystic episodes(6 months)
- CVF(6 months)
- Improvement of the quality of life(6 months)
- intensity of maximum VAS of the painful episodes(6 months)
- BMI(6 months)