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Active, Not Recruiting

NCT Number: NCT06359249

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cristina Segura Bayona

Igualada, Barcelona, 08700, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

change of habits

Behavioral

change of habits

change of habits + auto abdominal massage

Other

change of habits + auto abdominal massage

Primary outcomes

  1. Degree of constipation

    Time frame: Day 0, Month 3, Month 6

    Degree of constipation with Rome IV Criteria

  2. Stool characteristics

    Time frame: Day 0, Month 3, Month 6

    Stool characteristics with the Bristol Scale

  3. Quality of life focused on patients with constipation

    Time frame: 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.

  4. The number of laxatives taken by each participant

    Time frame: Month 3, Month 6

    The number of laxatives taken by each participant with an accounting schedule.

Secondary outcomes

  1. Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire.

    Time frame: Day 0, Month 3, Month 6

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Universitat de Vic

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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