Three-arm randomized clinical trial on the effect of non-pharmacological therapies during chest drain removal in post-cardiac surgery patients: study protocol

Three-arm randomized clinical trial on the effect of non-pharmacological therapies during chest drain removal in post-cardiac surgery patients: study protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Three-arm randomized clinical trial on the effect of non-pharmacological therapies during chest drain removal in post-cardiac surgery patients: study protocol Greys González-González, Karen Candia-Vásquez, Fabiola Fonseca-Nahuelcheo, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7942055/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Cardiovascular diseases are the leading cause of death globally, and the cardiac surgery contributing substantially to overall mortality and years of life lost due to disability. Cardiac surgery is an effective treatment strategy; however, the postoperative period is a critical phase for both rehabilitation and recovery. During this stage, the management of chest drains and related care plays a piv- otal role. Specifically, chest drain removal has been identified as a highly painful procedure for cardiac patients, potentially leading to complications such as atelec- tasis, delayed recovery, and acute pain. The use of non-pharmacological therapies (NPTs) to relief pain during chest drain removal has been scarcely investigated in Latin American populations. Among these interventions, local cold applica- tion and aromatherapy have shown promising effects in decreasing the immediate pain after chest tube removal. Objective compare the effectiveness of two non- pharmacological therapies with conventional treatment in managing pain during chest drain removal in patients undergoing cardiac surgery at a high-complexity hospital in southern Chile. Methods This single-blind, randomized controlled trial is designed to evaluate the effectiveness of non-pharmacological therapies compared with conventional pain management in patients undergoing cardiac surgery. The study protocol was developed in accordance with the SPIRIT (Stan- dard Protocol Items: Recommendations for Interventional Trials) guidelines. Discussion this is the first randomized clinical trial conducted in Chile and in the region comparing two non-pharmacological therapies with standard phar- macological analgesia alone in a high-complexity hospital setting. International evidence has demonstrated encouraging results regarding pain reduction using these techniques; however, findings remain heterogeneous, and consensus on their systematic integration into clinical practice is still lacking. This study aims to provide robust evidence to reduce variability in the use of NPTs and to advance the implementation of safe, low-cost, and easily applicable interventions in hos- pital settings. Trial registration: ClinicalTrials.gov Identifier: NCT06974071. Protocol version 1.0, May 15, 2025. Cardiac surgery chest drain non-pharmacological therapies Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7942055","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":535723596,"identity":"5d5310d1-6469-4e3b-adf2-316bec0e6fa2","order_by":0,"name":"Greys González-González","email":"","orcid":"","institution":"Universidad Autonoma de Barcelona","correspondingAuthor":false,"prefix":"","firstName":"Greys","middleName":"","lastName":"González-González","suffix":""},{"id":535723597,"identity":"9148724f-1437-4e57-8bca-eb240cf1e2d0","order_by":1,"name":"Karen Candia-Vásquez","email":"","orcid":"","institution":"Hospital Dr. Hernán Henríquez 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Cardiac surgery is an effective treatment strategy; however, the postoperative period is a critical phase for both rehabilitation and recovery. During this stage, the management of chest drains and related care plays a piv- otal role. Specifically, chest drain removal has been identified as a highly painful procedure for cardiac patients, potentially leading to complications such as atelec- tasis, delayed recovery, and acute pain. The use of non-pharmacological therapies (NPTs) to relief pain during chest drain removal has been scarcely investigated in Latin American populations. Among these interventions, local cold applica- tion and aromatherapy have shown promising effects in decreasing the immediate pain after chest tube removal.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective \u003c/strong\u003ecompare the effectiveness of two non- pharmacological therapies with conventional treatment in managing pain during chest drain removal in patients undergoing cardiac surgery at a high-complexity hospital in southern Chile.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods \u003c/strong\u003eThis single-blind, randomized controlled trial is designed to evaluate the effectiveness of non-pharmacological therapies compared with conventional pain management in patients undergoing cardiac surgery. The study protocol was developed in accordance with the SPIRIT (Stan- dard Protocol Items: Recommendations for Interventional Trials) guidelines.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion \u003c/strong\u003ethis is the first randomized clinical trial conducted in Chile and in the region comparing two non-pharmacological therapies with standard phar- macological analgesia alone in a high-complexity hospital setting. International evidence has demonstrated encouraging results regarding pain reduction using these techniques; however, findings remain heterogeneous, and consensus on their systematic integration into clinical practice is still lacking. 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