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

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.