[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652175":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Uludag University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Chitosan-Based Hemostatic Pad Group","EXPERIMENTAL","Patients receiving a chitosan-based hemostatic pad after femoral coronary angiography or percutaneous coronary intervention.",[13],"Other: Chitosan-Based Hemostatic Pad",{"label":15,"type":16,"description":17,"interventionNames":18},"Sandbag Group","ACTIVE_COMPARATOR","Patients receiving conventional sandbag application after femoral coronary angiography or percutaneous coronary intervention.",[19],"Other: Sandbag Application",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Chitosan-Based Hemostatic Pad","A chitosan-based hemostatic pad applied to the femoral puncture site after femoral coronary angiography or percutaneous coronary intervention to promote hemostasis and reduce vascular complications.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sandbag Application","Conventional sandbag application placed over the femoral puncture site following femoral coronary angiography or percutaneous coronary intervention to maintain hemostasis.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Yeliz Sapulu Alakan","CONTACT","90 505 850 0222","yelizsapulu@uludag.edu.tr",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":25,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Bursa Uludag University Hospital","RECRUITING","Bursa","Nilüfer","16059","Turkey (Türkiye)",{"type":45,"coordinates":46},"Point",[47,48],29.06013,40.19559,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":35},"Yeliz Alakan, Lecturer PhD","905058500222",{"type":55,"investigatorFullName":32,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Lecturer, PhD","100652175","hemostatc-pad-and-sandbag-100652175",false,"NCT07771127","HEMOSTATİC PAD AND SANDBAG","Comparison of Factors Related to Bleeding, Pain, Comfort Level, and Sleep Quality in Patients Undergoing Femoral Coronary Angiography Using a Chitosan-Containing Hemostatic Pad Versus a Sandbag","Inclusion Criteria:\n\n* Patients aged 18 years and older scheduled for femoral coronary angiography (CAG) and\u002For percutaneous coronary intervention (PCI)\n* Patients undergoing a single femoral arterial access procedure\n* Patients with sheath size typically 5-Fr, 6-Fr, or 7-Fr\n* Patients who are conscious, alert, and able to communicate\n* Patients who voluntarily agreed to participate in the study\n\nExclusion Criteria:\n\n* Patients with known allergy to shellfish or chitosan Patients using antihistamines, psychotropic medications, or sleep medications Patients with systolic and\u002For diastolic blood pressure above 150\u002F100 mmHg Patients with known bleeding disorders (e.g., hemophilia) or active bleeding Patients with severe renal or hepatic failure Pregnant or breastfeeding patients Patients with a history of malignancy","ALL","18 Years",{"count":67,"type":68},480,"ESTIMATED","INTERVENTIONAL",[71],"NA","The aim of this study is to compare bleeding outcomes, pain, comfort levels, sleep quality, and associated factors among patients receiving a chitosan-based hemostatic pad versus a sandbag following femoral coronary angiography (CAG) and percutaneous coronary intervention (PCI).\n\nFemoral coronary angiography (CAG) and percutaneous coronary intervention (PCI) are widely performed procedures for the diagnosis and treatment of coronary artery disease (CAD), which remains the leading cause of mortality worldwide (Batmaz \\& Cengiz, 2023; Wardiyana et al., 2024). Hemostasis following CAG and PCI is critical for preventing life-threatening complications, ensuring procedural success, and facilitating recovery. Vascular complications at the femoral arterial puncture site are among the most common adverse events associated with these procedures (Chen et al., 2021). Inadequate hemostasis may result in serious complications such as pseudoaneurysm, arteriovenous fistula, and retroperitoneal hemorrhage, all of which may pose significant risks to patient safety (Sauer et al., 2016). Effective bleeding control is particularly important in patients receiving intensive anticoagulant therapy.\n\nFollowing manual compression, sandbag application is commonly used to maintain hemostasis at the femoral access site. Typically, a sandbag weighing between 2.3 and 5 kilograms is placed over the puncture site, requiring patients to remain in a supine position with restricted mobility for approximately four to six hours (Batmaz \\& Cengiz, 2023). Although prolonged bed rest and sandbag application contribute to hemostasis, they may also lead to adverse patient experiences, including pain, discomfort, urinary retention, restlessness, and impaired sleep quality (Batmaz \\& Cengiz, 2023).\n\nAdvances in medical technology have led to the development of hemostatic devices designed to rapidly control bleeding independently of the body's natural coagulation mechanisms. Among these, chitosan-based hemostatic pads, derived from crustacean shells, have attracted increasing attention. Due to their positive electrical charge, chitosan molecules attract negatively charged erythrocytes and platelets, facilitating the rapid formation of a mechanical barrier and clot within seconds (Arbel et al., 2010; Kılıç et al., 2024). Previous studies have demonstrated that chitosan-based pads may reduce manual compression time and vascular complications such as ecchymosis and hematoma (Ginanjar et al., 2018; Kılıç et al., 2024; Qian et al., 2024). Furthermore, they have been associated with improved patient comfort, earlier mobilization, and shorter hospital stays (Kılıç et al., 2024; Liu, 2025).\n\nThe responsibilities of nurses following CAG and PCI extend beyond bleeding control and include comprehensive monitoring of vital signs, early detection of complications, and the promotion of patient comfort and well-being (Batmaz \\& Cengiz, 2023; Rodrigues et al., 2024). While existing studies have primarily focused on the effectiveness of chitosan-based pads in reducing hematoma formation (Bektaş et al., 2017), evidence regarding their effects on broader patient-centered outcomes remains limited. Therefore, this study seeks to provide a comprehensive evaluation of chitosan-based hemostatic pads and conventional sandbag application with respect to bleeding outcomes, pain, patient comfort, and sleep quality.\n\nAccordingly, the present study aims to compare bleeding, pain, comfort levels, sleep quality, and related factors among patients undergoing femoral CAG and PCI who receive either a chitosan-based hemostatic pad or a sandbag for post-procedural hemostasis.\n\nThe sample size was calculated using a power analysis based on an effect size of 0.40, a significance level of 5% (α = 0.05), and a statistical power of 80% (1-β = 0.80). According to the analysis, a total of 480 participants will be recruited, including 240 patients in the chitosan-based hemostatic pad group and 240 patients in the sandbag group.",[74,75,76],"Coronary Artery Disease","Coronary Angiography","Vascular Access Site Complications","2026-08-13",{"date":79,"type":80},"2026-08-18","ACTUAL",{"date":82,"type":80},"2026-06-10",{"date":84,"type":68},"2026-12-30",{"name":5,"class":6},1]