Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioura… (NCT06359249) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?
Spain45 participantsStarted 2024-03-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Having been diagnosed with primary constipation using Rome IV Criteria(11), of more than three months' duration.
* Understanding Catalan, Spanish or English.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Degree of constipation
Timeframe: Day 0, Month 3, Month 6
2
Stool characteristics
Timeframe: Day 0, Month 3, Month 6
3
Quality of life focused on patients with constipation
Timeframe: Day 0, Month 3, Month 6
4
The number of laxatives taken by each participant
Timeframe: Month 3, Month 6
Trial details
NCT IDNCT06359249
SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina