{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:59:42Z","timestamp":1782845982556,"version":"3.54.5"},"reference-count":39,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to evaluate the effectiveness of a primary care\u2013based 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.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This is a randomized controlled trial involving adults aged 18 to 75 years from the counties of l\u2019Anoia 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\u201023 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\n \u03c7<\/jats:italic>\n 2<\/jats:sup>\n test, a 2-tailed\n t<\/jats:italic>\n test, and ANOVA\/Kruskal-Wallis tests, depending on variable type.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Participant enrollment concluded in August 2025, and data collection is ongoing and expected to continue until April 2026.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/72018","type":"journal-article","created":{"date-parts":[[2025,10,5]],"date-time":"2025-10-05T14:40:08Z","timestamp":1759675208000},"page":"e72018-e72018","source":"Crossref","is-referenced-by-count":2,"title":["A Primary Care Program Based on Behavioral Reeducation and Abdominal Massage for Improving the Symptoms of Chronic Constipation: Protocol for a Randomized Controlled Trial"],"prefix":"10.2196","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-4467-1184","authenticated-orcid":false,"given":"Cristina","family":"Segura-Bayona","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3527-4242","authenticated-orcid":false,"given":"Josep","family":"Vidal-Alaball","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8263-1292","authenticated-orcid":false,"given":"Anna","family":"Ram\u00edrez-Morros","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7379-4671","authenticated-orcid":false,"given":"Queralt","family":"Mir\u00f3-Catalina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2848-2326","authenticated-orcid":false,"given":"Anna","family":"Ruiz-Comellas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,12,4]]},"reference":[{"issue":"1","key":"R1","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1080\/17474124.2020.1708718","article-title":"An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation","volume":"14","author":"Aziz","journal-title":"Expert Rev Gastroenterol Hepatol"},{"key":"R2","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2017.95","article-title":"Chronic constipation","volume":"3","author":"Camilleri","journal-title":"Nat Rev Dis Primers"},{"issue":"8","key":"R3","doi-asserted-by":"publisher","first-page":"638","DOI":"10.1016\/S2468-1253(21)00111-4","article-title":"Global prevalence of functional constipation according to the Rome criteria: a systematic review and meta-analysis","volume":"6","author":"Barberio","journal-title":"Lancet Gastroenterol Hepatol"},{"issue":"1","key":"R4","doi-asserted-by":"publisher","first-page":"211","DOI":"10.1053\/j.gastro.2012.10.029","article-title":"American Gastroenterological Association medical position statement on constipation","volume":"144","author":"American Gastroenterological Association","journal-title":"Gastroenterology"},{"key":"R5","doi-asserted-by":"publisher","DOI":"10.1186\/1471-230X-8-5","article-title":"Epidemiology of constipation in Europe and Oceania: a systematic review","volume":"8","author":"Peppas","journal-title":"BMC Gastroenterol"},{"issue":"February","key":"R6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3389\/fmed.2022.815156","article-title":"Prevalence and risk factors of functional constipation according to the Rome criteria in China: a systematic review and meta-analysis","volume":"9","author":"Chen","journal-title":"Front Med"},{"issue":"11","key":"R7","doi-asserted-by":"publisher","first-page":"2366","DOI":"10.1111\/apa.15248","article-title":"A large-scale study to describe the prevalence, characteristics and management of functional gastrointestinal disorders in African infants","volume":"109","author":"Bellaiche","journal-title":"Acta Paediatr"},{"key":"R8","unstructured":"Estre\u00f1imiento. Fundaci\u00f3n Espa\u00f1ola del Aparato Digestivo. URL: https:\/\/www.saludigestivo.es\/mes-saludigestivo\/estrenimiento\/ [Accessed 07-02-2024]"},{"issue":"1","key":"R9","doi-asserted-by":"publisher","first-page":"4","DOI":"10.4321\/S1699-695X2015000100002","article-title":"Frequency of constipation in primary care patients","volume":"8","author":"Navarro Ruiz","journal-title":"Rev Clin Med Fam"},{"issue":"9","key":"R10","doi-asserted-by":"publisher","first-page":"1582","DOI":"10.1038\/ajg.2011.164","article-title":"Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis","volume":"106","author":"Suares","journal-title":"Am J Gastroenterol"},{"issue":"10","key":"R11","doi-asserted-by":"publisher","first-page":"464","DOI":"10.1016\/j.medcli.2016.12.020","article-title":"The new Rome criteria (IV) of functional digestive disorders in clinical practice","volume":"148","author":"Sebasti\u00e1n Domingo","journal-title":"Med Clin (Barc)"},{"issue":"1","key":"R12","doi-asserted-by":"publisher","first-page":"142","DOI":"10.1177\/2050640614558476","article-title":"Chronic constipation and co-morbidities: a prospective population-based nested case-control study","volume":"4","author":"Choung","journal-title":"United European Gastroenterol J"},{"issue":"11","key":"R13","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s11894-020-00791-1","article-title":"Constipation and fecal incontinence in the elderly","volume":"22","author":"Deb","journal-title":"Curr Gastroenterol Rep"},{"issue":"4","key":"R14","doi-asserted-by":"publisher","first-page":"289","DOI":"10.5152\/tjg.2020.19183","article-title":"Recovery from hemorrhoids and anal fissure without surgery","volume":"31","author":"\u015ei\u015fik","journal-title":"Turk J Gastroenterol"},{"issue":"3","key":"R15","first-page":"179","volume":"96","author":"Iglesia","journal-title":"Am Fam Physician"},{"issue":"1","key":"R16","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1055\/s-0032-1301760","article-title":"Fecal impaction: a cause for concern?","volume":"25","author":"Obokhare","journal-title":"Clin Colon Rectal Surg"},{"key":"R17","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijscr.2017.11.060","article-title":"Opioid drugs and stercoral perforation of the colon: case report and review of literature","volume":"42","author":"Poitras","journal-title":"Int J Surg Case Rep"},{"issue":"2","key":"R18","doi-asserted-by":"publisher","first-page":"146","DOI":"10.4321\/s1130-01082009000200012","article-title":"Stercoral perforation of the colon","volume":"101","author":"Vilallonga","journal-title":"Rev Esp Enferm Dig"},{"issue":"2","key":"R19","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1159\/000516976","article-title":"Chronic constipation: gastroenterohepatologist\u2019s approach","volume":"40","author":"Milosavljevic","journal-title":"Dig Dis"},{"issue":"1","key":"R20","doi-asserted-by":"publisher","first-page":"180","DOI":"10.3390\/medicina60010108","article-title":"Idiopathic slow transit constipation: pathophysiology, diagnosis, and management","volume":"60","author":"Vlismas","journal-title":"Medicina (Kaunas)"},{"issue":"1","key":"R21","doi-asserted-by":"publisher","first-page":"7","DOI":"10.2169\/internalmedicine.2867-23","article-title":"Management of chronic constipation: a comprehensive review","volume":"64","author":"Hojo","journal-title":"Intern Med"},{"issue":"14","key":"R22","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3310\/pgfar09140","article-title":"Non-drug therapies for the management of chronic constipation in adults: the CapaCiTY research programme including three RCTs","volume":"9","author":"Knowles","journal-title":"Programme Grants Appl Res"},{"issue":"11","key":"R23","doi-asserted-by":"publisher","first-page":"2243","DOI":"10.1111\/codi.16738","article-title":"Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: a randomized controlled trial","volume":"25","author":"Norton","journal-title":"Colorectal Dis"},{"issue":"6","key":"R24","doi-asserted-by":"publisher","first-page":"332","DOI":"10.17235\/reed.2016.4389\/2016","article-title":"Clinical practice guideline: irritable bowel syndrome with constipation and functional constipation in the adult","volume":"108","author":"Mearin","journal-title":"Rev Esp Enferm Dig"},{"key":"R25","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijnurstu.2024.104936","article-title":"Effectiveness of abdominal massage on chronic constipation in adults: a systematic review and meta-analysis","volume":"161","author":"Huang","journal-title":"Int J Nurs Stud"},{"key":"R26","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctim.2019.102219","article-title":"Effect of abdominal massage on constipation and quality of life in older adults: a randomized controlled trial","volume":"47","author":"Birimoglu Okuyan","journal-title":"Complement Ther Med"},{"issue":"1","key":"R27","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1159\/000540912","article-title":"Evidence-Based clinical guidelines for chronic constipation 2023","volume":"106","author":"Ihara","journal-title":"Digestion"},{"key":"R28","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials","volume":"346","author":"Chan","journal-title":"BMJ"},{"issue":"5","key":"R29","doi-asserted-by":"publisher","first-page":"312","DOI":"10.4321\/s1130-01082009000500002","article-title":"Adaptation and validation of the Bristol Scale Stool Form translated into the Spanish language among health professionals and patients","volume":"101","author":"Par\u00e9s","journal-title":"Rev Esp Enferm Dig"},{"issue":"10","key":"R30","doi-asserted-by":"publisher","first-page":"371","DOI":"10.1016\/S0025-7753(08)72285-1","article-title":"Cuestionario espec\u00edfico de calidad de vida para pacientes con estre\u00f1imiento: desarrollo y validaci\u00f3n del CVE-20","volume":"131","author":"Perona","journal-title":"Medicina Cl\u00ednica"},{"issue":"8","key":"R31","doi-asserted-by":"publisher","first-page":"1381","DOI":"10.1249\/01.MSS.0000078924.61453.FB","article-title":"International Physical Activity Questionnaire: 12-country reliability and validity","volume":"35","author":"Craig","journal-title":"Med Sci Sports Exerc"},{"issue":"2","key":"R32","doi-asserted-by":"publisher","DOI":"10.3390\/life13020430","article-title":"Transcutaneous neuromodulation for constipation and fecal incontinence in children: a systematic review and meta-analysis","volume":"13","author":"Correia","journal-title":"Life (Basel)"},{"issue":"1","key":"R33","doi-asserted-by":"publisher","first-page":"159","DOI":"10.1016\/j.bpg.2011.01.004","article-title":"Biofeedback therapy for constipation in adults","volume":"25","author":"Rao","journal-title":"Best Pract Res Clin Gastroenterol"},{"issue":"9","key":"R34","doi-asserted-by":"publisher","first-page":"611","DOI":"10.1007\/s10151-016-1507-6","article-title":"Biofeedback treatment of chronic constipation: myths and misconceptions","volume":"20","author":"Chiarioni","journal-title":"Tech Coloproctol"},{"issue":"3","key":"R35","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-020400","article-title":"Acupuncture for constipation in patients with stroke: protocol of a systematic review and meta-analysis","volume":"8","author":"Zhai","journal-title":"BMJ Open"},{"issue":"1","key":"R36","doi-asserted-by":"publisher","DOI":"10.1186\/s12906-018-2243-4","article-title":"Efficacy and safety of acupuncture for functional constipation: a randomised, sham-controlled pilot trial","volume":"18","author":"Lee","journal-title":"BMC Complement Altern Med"},{"issue":"7","key":"R37","doi-asserted-by":"publisher","first-page":"744","DOI":"10.1007\/s11427-017-9220-7","article-title":"Microbial treatment in chronic constipation","volume":"61","author":"Huang","journal-title":"Sci China Life Sci"},{"issue":"40","key":"R38","doi-asserted-by":"publisher","first-page":"11439","DOI":"10.3748\/wjg.v21.i40.11439","article-title":"Aspects of the non-pharmacological treatment of irritable bowel syndrome","volume":"21","author":"Eriksson","journal-title":"World J Gastroenterol"},{"issue":"21","key":"R39","doi-asserted-by":"publisher","first-page":"3446","DOI":"10.12998\/wjcc.v7.i21.3446","article-title":"Effect of cognitive behavior therapy combined with exercise intervention on the cognitive bias and coping styles of diarrhea-predominant irritable bowel syndrome patients","volume":"7","author":"Zhao","journal-title":"World J Clin Cases"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e72018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:02:04Z","timestamp":1782842524000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e72018"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,4]]},"references-count":39,"URL":"https:\/\/doi.org\/10.2196\/72018","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,4]]},"article-number":"v14i1e72018"}}