A Primary Care Program Based on Behavioral Reeducation and Abdominal Massage for Improving the Symptoms of Chronic Constipation: Protocol for a Randomized Controlled Trial #MMPMID41343762
Segura-Bayona C; Vidal-Alaball J; Ramirez-Morros A; Miro-Catalina Q; Ruiz-Comellas A
JMIR Res Protoc 2025[Dec]; 14 (?): e72018 PMID41343762show ga
BACKGROUND: Chronic constipation is a prevalent and often underestimated gastrointestinal disorder that significantly affects quality of life, particularly among women and older adults. In Spain, it is estimated to affect between 12% and 20% of the population, contributing to increased health care visits, economic costs, and medication dependency. Although pharmacological treatments such as laxatives are widely used, they often offer only temporary relief and may lead to adverse effects or dependency. There is growing interest in nonpharmacological interventions that address the root behavioral and functional causes of constipation, such as dietary habits, physical inactivity, and impaired defecation techniques. However, evidence regarding the effectiveness of such approaches, especially within a primary care setting, remains limited. OBJECTIVE: This study aims to evaluate the effectiveness of a primary care-based structured rehabilitation program that combines behavioral reeducation and abdominal massage therapy in reducing the severity of chronic constipation and use of laxatives. A secondary aim is to assess improvements in quality of life and sustainability of effects over time. METHODS: This is a randomized controlled trial involving adults aged 18 to 75 years from the counties of l'Anoia and Bages (Catalonia, Spain) who meet the Rome IV diagnostic criteria for chronic constipation. A total of 45 participants will be randomly assigned in a 1:1:1 ratio (approximately 22-23 per center, with 15 per group overall) into 3 groups: a control group, behavioral intervention (BI) group, and behavioral intervention and massage (BIM) group. All participants will complete baseline assessments that include the Rome IV criteria, the Bristol Stool Form Scale, the CVE-20 quality of life questionnaire, and the International Physical Activity Questionnaire. The BI group will receive 2 group education sessions, focused on healthy bowel habits, diet, hydration, physical activity, stress management, and medication use, delivered by a multidisciplinary team. The BIM group will receive the same intervention as the BI group, plus two 30-minute sessions with a physiotherapist to learn abdominal self-massage techniques. The control group will receive usual care. Follow-up assessments will occur at 3 and 6 months after the intervention using the same instruments and a self-recorded calendar of laxative use and massage application. Data will be analyzed using appropriate statistical tests, including the chi2 test, a 2-tailed t test, and ANOVA/Kruskal-Wallis tests, depending on variable type. RESULTS: Participant enrollment concluded in August 2025, and data collection is ongoing and expected to continue until April 2026. CONCLUSIONS: This trial will provide evidence on the efficacy of conservative, low-risk interventions for managing chronic constipation in primary care. The findings may support broader implementation of integrative approaches that reduce pharmacological dependence and enhance patient empowerment, with potential public health and economic benefits.
JMIR+Res+Protoc 2025 ; 14 (?): e72018
