Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of rumination events after a challenge meal measured by an event marker.
研究概览
简要总结
Background: Rumination syndrome is characterized by the involuntary regurgitation of previously ingested food from the stomach to the mouth, triggered by an unintentional contraction of the abdominal muscles along with simultaneous relaxation of the esophageal sphincters. Based on this mechanism, a biofeedback technique targeting muscular activity has been developed and shown to be effective. However, such techniques are often complex and not widely accessible.
Hypothesis: Rumination can be effectively treated using a simplified, non-instrumental biofeedback technique based on cognitive intervention.
Objective: To evaluate the effectiveness of a non-instrumental biofeedback technique incorporating cognitive intervention for the treatment of rumination. The methodology will build on prior studies, employing a more streamlined biofeedback approach.
Methods: Participants will be assigned to parallel groups with balanced sex distribution. The study will compare responses to biofeedback versus a control intervention. Over a four-week period, each participant will undergo three treatment sessions:
The biofeedback group will be trained to control abdominothoracic musculature through cognitive intervention, supported by original visual materials, both before and after a standardized test meal.
The control group will receive a placebo capsule prior to the test meal, and regurgitation episodes will be recorded.
Following the initial session, biofeedback participants will continue with daily exercises, while control participants will take a placebo with each meal. Treatment response will be assessed by comparing outcomes before and after the intervention. After post-treatment assessment, control group participants will be offered the opportunity to receive biofeedback therapy.
Relevance: This project aims to determine the efficacy of a simplified mechanistic intervention for rumination. If successful, this approach could be adopted in additional healthcare settings.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rumination syndrome
排除标准
- •Relevant organic diseases
研究组 & 干预措施
Biofeedback
Three biofeedback sessions will be administered during the first three weeks of the intervention period. In each session, participants will receive a standardized meal and undergo training to control abdominal and thoracic muscular activity. This training will be guided by a trained operator using original audiovisual materials and hands-on techniques. Regurgitation episodes will be recorded by participants using an event marker. Following each session, participants will be instructed to perform the same exercises before and after breakfast, lunch, and dinner throughout the four-week intervention period.
干预措施: Biofeedback (Behavioral)
Placebo
Three treatment sessions will be conducted during the first three weeks of the intervention period. In each session, participants will receive a placebo capsule prior to a standardized meal and will be instructed to record the number of regurgitation episodes using an event marker. Following each session, participants will be asked to take a placebo capsule before each meal throughout the four-week intervention period.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of rumination events after a challenge meal measured by an event marker.
时间窗: 4 weeks
Each regurgitation event will be registered by the patient using an event marker.
Number of rumination events after a challenge meal measured by an event marker.
时间窗: 4 weeks
Each regurgitation event will be registered by the patient using an event marker.
次要结局
- Number of self perceived rumination events(4 weeks)
- Number of rumination events(6 months)
- Quantity of meal regurgitated(4 weeks)
- Number of self perceived rumination events(4 weeks)
- Number of rumination events(6 months)
- Quantity of meal regurgitated(4 weeks)
- Number of rumination events(1 month)
- Number of rumination events(3 months)