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Clinical Trials in Spain / NCT06359249
Active, not recruiting Not applicable

Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage?

NCT06359249 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Phase
Not applicable
Started
2024-03-01
Last updated
2026-08-19

Condition(s) studied

Constipation Chronic Idiopathic

Investigational drug(s) / intervention(s)

change of habitschange of habits + auto abdominal massage

change of habits: change of habits

change of habits + auto abdominal massage: change of habits + auto abdominal massage

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Degree of constipation — Before intervention (Tpre), Day 0, Month 3, Month 6
    Degree of constipation with Rome IV Criteria
  • Stool characteristics — Day 0, Month 3, Month 6
    Stool characteristics with the Bristol Scale
  • Quality of life focused on patients with constipation — 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.
  • The number of laxatives taken by each participant — Month 3, Month 6
    The number of laxatives taken by each participant with an accounting schedule.

Trial sites (1)

FacilityCityRegionStatus
Cristina Segura Bayona Igualada Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06359249 on ClinicalTrials.gov ↗ ← All trials in Spain