Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359249
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-18
Brief Title:
Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Constipation is one of the most common digestive problems in todays 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 todays 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 LAnoia 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 LAnoia Catalonia Spain
Inclusion criteria
Having been diagnosed with primary constipation using Rome IV Criteria11 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 andor 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
Method Randomised clinical trial Participants people with constipation in the region of LAnoia 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 LAnoia Catalonia Spain
Inclusion criteria
Having been diagnosed with primary constipation using Rome IV Criteria11 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None