Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mid term hypnosis efficacy with IBDQ
研究概览
简要总结
Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;
详细描述
Crohn disease is defined as an inflammatory chronic disease of the bowel characterize by intermittent flare-ups and remission periods.
Crohn disease is due to genetic and environmental factors such as stress. Stress is an important aggravation factor of the disease symptoms which can stop a remission period and induce a relapse into a flare-up period.
Hypnosis is a non-medicinal technic which already show efficacy in the treatment of functional digestive troubles. These diseases are bio/psycho/social models such as Crohn disease.
Hypnosis can reduce visceral pain sensibility, reduce stress and reduce pro-inflammatory cytokines liberation into intestinal mucosa.
Though, only few data are available on hypnosis interest in the treatment of Crohn disease and inflammatory bowel diseases as it is often isolated clinical case report.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with ileal or colic Crohn disease
- •stable treatment for Crohn disease
- •clinical and biologic remission (normal C reactive protein and fecal calprotectin < 100 µg/g)
- •patient living in Grenoble area
- •informed consent form
- •social security affiliation
排除标准
- •Person under legal protection (articles L1121-5 and L1121-8 of Public health code)
- •Person in exclusion period of another study
- •Hypnosis contraindication
研究组 & 干预措施
immunosuppressor/TNFalpha
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment.
干预措施: immunosuppressor/TNFalpha (Drug)
Hypnosis + Standard Treatment
Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment.
干预措施: Hypnosis (Behavioral)
结局指标
主要结局
Mid term hypnosis efficacy with IBDQ
时间窗: 6 months
Efficacy evaluation of hypnosis 6 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
次要结局
- Short term hypnosis efficacy with IBDQ(3 months)
- Disease acceptance with ICQ-18(3 months and 6 months)
- Clinical score with Harvey-Bradshaw Index short and mid term(3 months and 6 months)
- Vagal tonus with electrocardiogram(3 months and 6 months)
- Inflammatory status with C Reactive Protein(3 months and 6 months)
- Stress with Perceived Stress Scale(3 months and 6 months)
- Fatigue with Multidimensional Fatigue Inventory(3 months and 6 months)
- Long term hypnosis efficacy(12 months)
- Clinical score with Harvey-Bradshaw Index long term(12 months)