Coronary artery disease (CAD) remains a leading cause of morbidity and mortality worldwide, necessitating advancements in diagnostic techniques (Parulkar et al., 2025). According to the British Heart Foundation, over 250 million individuals worldwide are living with CAD, making it the most commonly diagnosed heart condition globally. In 2021, CAD was responsible for approximately 9 million deaths, accounting for about one in every seven deaths globally
Complications associated with PCI significantly impact patient outcomes and place substantial demands on healthcare systems. These adverse events contribute to increased morbidity and mortality rates, prolonged hospitalizations, higher healthcare expenditures, and longer 0waiting times for subsequent cardiac procedures. (Guedeney et al., 2024; Ntow, Agyeman, Aryal, \& Patel, 2024) . Postoperative pain remains a prevalent concern following PCI, particularly after femoral catheter removal, with approximately 33% of patients reporting discomfort at the access site (Al-Zuhairi \& Abed, 2024). Although this pain typically subsides over time, it can significantly affect patient comfort and recovery in the immediate post-procedural phase. In addition to pain, hematoma formation is among the most frequent vascular complications associated with femoral artery access, with a reported prevalence of up to 15.5% (Zhi et al., 2024). These hematomas, resulting from bleeding at the puncture site, can range from minor bruising to substantial blood collections, potentially leading to pain, swelling, and further clinical complications (Hamdi, Abd El Megeed, Abd Al Ghaffare, \& Abdelmowla, 2023). Traditional pressure application remains a commonly employed strategy in clinical settings for managing such hematomas and mitigating their progression (Rodgers et al., 2025). Cryotherapy, or cold therapy, is a well-established non-pharmacological intervention widely utilized in clinical practice to alleviate pain, reduce swelling, and control inflammation. This method typically involves the localized application of ice packs or bags, which may range from specially designed medical devices to simple waterproof plastic bags (Garcia, Karri, Zacharias, \& Abd-Elsayed, 2021). In the context of PCI care, cryotherapy has shown promise in minimizing vascular complications following femoral arterial sheath removal. The application of a cold pack to the femoral region can aid in reducing pain, controlling bleeding, and limiting hematoma formation. The therapeutic effect is primarily attributed to the vasoconstriction induced by cold exposure, which enhances coagulation, decreases local blood flow, and increases blood viscosity (Al-Bayati \& Al-Kassar, 2023). Additionally, it decreases temperature by primarily reducing metabolic activity, which reduces inflammatory response as well as reduces nerve conductivity, thereby slowing pain impulse transmission and decreasing pain perception and tissue damage (Behera \& Shetty, 2023). The significance of this study lies in its potential to enhance post-PCI patient care through a simple, non-pharmacological intervention. Growing evidence supports the clinical effectiveness of ice bag application in managing complications associated with femoral catheter removal. Research by )Al-Zuhairi and Abed 2024), and )Pamuk and Özkaraman 2024), confirmed that localized ice therapy significantly alleviates pain and reduces vascular complications following PCI, emphasizing its role in improving patient comfort and outcomes. Furthermore, findings by (Suhanda Putri, and Setiawan, 2023), and (Kristiyan, Purnomo, and Ropyant 2019), demonstrated that cold pack application effectively minimizes hematoma formation, showing superiority over traditional methods such as sandbag use. While )Valikhani, Mahdizadeh, Eshraghi, Mazloum, and Dehghani, 2020), reported no statistically significant differences between cryotherapy and control groups, their findings may be attributed to shorter application durations. This variation shows how important it is to have a clear and consistent protocol, as highlighted in the randomized controlled trial by ( Sokhanvar, Tirgari, Forouzi, Salari, and Jahani, 2023), which focused on differences in how and when the cold therapy was applied. Together, these studies highlight the need for continued research to develop standardized, evidence-based protocols for the use of ice bag application in post-PCI care. This study aims to build on existing evidence by evaluating the effectiveness of ice therapy in reducing complications and improving patient outcomes. By doing so, it seeks to promote a simple, practical, and effective method for managing common post-PCI issues-one that can be easily implemented in clinical settings to enhance recovery and increase patient satisfaction.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
cold therapy, consisting of an ice bag maintained at a temperature of 0-4°C, applied to the femoral region for 20 minutes with 10-minute intervals during the first two hours following PCI
Pain Level
Assessed using a standardized pain scale
Time frame: 3 months
Hematoma Formation
Presence and size of hematoma at the puncture site, measured in centimeters using hematoma scale
Time frame: 3 months
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