Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Quality of life focused on patients with constipation
研究概览
简要总结
Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term.
详细描述
Background: Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term.
Method: Randomised clinical trial. Participants: people with constipation in the region of L'Anoia, Catalonia. There will be 3 groups: the control group (CG), behavioural intervention group (BIG) and behavioural intervention and massage group (BIMG). Constipation will be assessed with the Bristol scale, Rome IV Criteria and the number of laxatives; and quality of life with the CVE-20 Questionnaire.
Participants will be proposed from Primary Care Centres in the region of L'Anoia, Catalonia, Spain.
Inclusion criteria:
- Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
- Understanding Catalan, Spanish or English.
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 (Outcomes Assessor)
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
- •Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
- •Understanding Catalan, Spanish or English.
排除标准
- •Having constipation secondary to neurogenic, metabolic, endocrine or postoperative diseases.
- •Having constipation secondary to medication for other pathologies, the medication list for which can be found in the annex.
- •Having any type of open abdominal and/or anal wound, such as a recent abdominal scar or anal fissure.
- •Meeting any absolute contraindication criteria for the use of abdominal massage therapy, such as an unstable fracture requiring absolute rest and immobilisation, pregnancy or active oncological procedures.
- •Suffering from some type of cognitive, psychiatric or neurological alteration that does not allow to understand the project.
研究组 & 干预措施
behavioural intervention and massage group
Conductual and abdominal massage treatment
干预措施: change of habits + auto abdominal massage (Other)
Control group
Habitual treatment
behavioural intervention group
Conductual treatment
干预措施: change of habits (Behavioral)
结局指标
主要结局
Quality of life focused on patients with constipation
时间窗: Day 0, Month 3, Month 6
Quality of life focused on patients with constipation with the CVE-20 questionnaire from an emotional, physical and social viewpoint.
Degree of constipation
时间窗: Before intervention (Tpre), Day 0, Month 3, Month 6
Degree of constipation with Rome IV Criteria
Stool characteristics
时间窗: Day 0, Month 3, Month 6
Stool characteristics with the Bristol Scale
The number of laxatives taken by each participant
时间窗: Month 3, Month 6
The number of laxatives taken by each participant with an accounting schedule.
次要结局
- Sex(Before intervention (Tpre))
- Age(Before intervention (Tpre))
- Level of physical activity(Day 0, Month 3, Month 6)
- Previous conditions(Before intervention (Tpre))