Effectiveness of Combined Sandbag and Ice Pack Application in Reducing Hematoma and Pain After Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial
DOI:
https://doi.org/10.20956/p5ky7h45Keywords:
hematoma, ice pack, pain, post-percutaneous coronary intervention, sandbagAbstract
Aims: Hematoma and pain are common complications in patients undergoing percutaneous coronary intervention (PCI) using a femoral sheath. Nonpharmacological interventions, such as sandbags and ice packs, are commonly used to promote hemostasis. This study aimed to compare the effectiveness of using a sandbag and an ice pack in reducing hematoma and pain after femoral sheath removal in patients undergoing PCI.
Methods: A single-blind randomized controlled trial (RCT) was conducted to compare hematoma size and pain level in post-PCI patients with femoral sheath across three intervention groups: (1) combined sandbag and ice pack (n=20), (2) sandbag only (n=20), and (3) ice pack only (n=20). Participants were randomly allocated using a Random Number Generator. The ice pack intervention was applied for 20 min, whereas the sandbag intervention was applied for 2 h. This study was conducted in three coronary wards with 60 participants. Hematoma size and pain level were the primary outcome measures. Hematoma size was measured using a measuring tape in millimeters (mm), and pain was assessed using the Numeric Rating Scale (NRS). Data were analyzed using the Kruskal–Wallis and Friedman tests.
Results: The Kruskal–Wallis test showed no significant difference in hematoma size and pain scale at measurement 1 (0 min) and measurement 2 (20 min) among the three groups (p>0.05). However, significant differences were found at the 2 h assessment for hematoma size (p=0.011) and pain score (p=0.002), with large effect sizes ranging from 0.588 to 0.728. Post hoc analysis using the Mann–Whitney U test with Bonferroni correction showed that the combined sandbag and ice pack group had significantly greater reductions in hematoma size and pain than ice pack only group and the sandbag only group. No intervention-related discomfort or adverse responses were reported by the participants.
Conclusion: The results of this study indicate that significant differences between the intervention groups began to emerge at the 2-hour mark, with a large effect size. The combined sandbag and ice pack was the most effective intervention for reducing hematoma size and pain level, followed by the ice pack-only and sandbag-only groups. Therefore, the combined sandbag and ice pack is recommended as the preferred intervention for post-PCI patients with a femoral sheath.
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