NCT02854306已完成不适用
Psycho-sensorial Mindfulness and Top-down Control : Mindfulness Program for Obese Patients in Preparation to Bariatric Surgery
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Psychometric evaluation
研究概览
简要总结
Mindfulness is a common practice already widely used, that has shown benefits in terms of psychological and physical health. It is about learning or learn again to be self present and aware to the environment, across breathing, sensations, emotions and thought centering exercises, in the present moment without any judgement.
The goal is to evaluate the efficacy of "mindfulness" versus an active control group in bariatric surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients: over 18 years
- •Patients suffering from morbid obesity (BMI ≥ 40 kg/m²), or severe obesity (BMI ≥ 35 kg/m²) associate with at least a comorbidity likely to be improved by surgery
- •Patient revised in second-line after the failure of a well conducted medical treatment, nutritional, dietetic and psychotherapeutic during 6 to 12 months : absence of enough weight loss or absence of maintain of weight loss
- •Absence of any psychiatric counter-argument
排除标准
- •Subjects responding to inclusion criteria of the French National Authority for Health
- •Subjects without agoraphobia, or obsessive-compulsive disorder, in post-traumatic stress disorder, alcohol or drugs dependant, without psychotic disorders, major depressive disorder, or suffering from anti-social personality disorder
- •Patient registered for social security
- •Free, signed and informed consent
研究组 & 干预措施
Surgery
Active Comparator
Obese patient without mindfulness program in parallel.
干预措施: Bariatric surgery (Procedure)
Surgery with mindfulness program
Active Comparator
Obese patient following a mindfulness program in parallel.
干预措施: Bariatric surgery (Procedure)
结局指标
主要结局
Psychometric evaluation
时间窗: 15 minutes
Tool : BAQ-18- Body Awareness Questionnaire
次要结局
未报告次要终点
研究者
研究点 (2)
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