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

NCT ID: NCT06359249

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-12-28

Brief 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.

Detailed Description

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.

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.

Discussion: Research is needed on conservative, non-pharmacological treatment to try to reduce one of the main conditions affecting public health, and thus reduce the possible illnesses associated with constipation and reduce costs to the health system.

Conditions

Constipation Chronic Idiopathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Habitual treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

behavioural intervention group

Conductual treatment

Group Type: EXPERIMENTAL

change of habits

Intervention Type: BEHAVIORAL

change of habits

behavioural intervention and massage group

Conductual and abdominal massage treatment

Group Type: EXPERIMENTAL

change of habits + auto abdominal massage

Intervention Type: OTHER

change of habits + auto abdominal massage

Interventions

change of habits

change of habits

Intervention Type: BEHAVIORAL

change of habits + auto abdominal massage

change of habits + auto abdominal massage

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat de Vic

UNKNOWN

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cristina Segura Bayona

Igualada, Barcelona, Spain

Countries

Spain

Other Identifiers

V.3-06/02/2024

Identifier Type: -

Identifier Source: org_study_id