NURSING CARE PACKAGE REDUCES PAIN AND BRUISING FROM SUBCUTANEOUS ANTICOAGULANTS: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background: Subcutaneous injectable anticoagulants, particularly low-molecular-weight heparins (LMWHs), constitute the cornerstone of venous thromboembolism (VTE) prophylaxis and treatment in hospitalized patients. Despite their established clinical efficacy, local adverse effects — notably pain and bruising at injection sites — are prevalent, undermining patient comfort, psychological well-being, and potentially compromising adherence to prescribed therapy. Variability in nursing injection technique represents a modifiable determinant of these adverse outcomes; however, standardized, evidence-based nursing care packages addressing the full spectrum of injection-related practices remain insufficiently studied, particularly in the Indian clinical context.

Objectives: (1) To determine the prevalence of local adverse effects among hospitalized patients receiving subcutaneous injectable anticoagulants; (2) to evaluate the effectiveness of a structured nursing care package on pain and bruising; (3) to compare adverse effect outcomes between the experimental and control groups; and (4) to examine the association between pain and selected co-morbid conditions.

Methods: A randomized controlled trial (RCT) with a parallel-group design was conducted among 180 hospitalized patients receiving subcutaneous anticoagulants (enoxaparin, dalteparin, or unfractionated heparin). Participants were randomly allocated (1:1) to an experimental group (n=90) receiving a structured nursing care package (comprising site rotation, pre-injection cold application, optimized needle gauge, slow-rate injection, air-bubble retention technique, and 60-second post-injection pressure) or a control group (n=90) receiving routine hospital care. The primary outcome was pain intensity, assessed using a standardized six-point categorical pain scale; the secondary outcome was bruising severity, measured by a five-point bruise scale. Assessments were performed at baseline (Day 0) and post-intervention (Day 7). Paired t-tests and chi-square analyses were employed; significance was set at p<0.05.

Results: Of 720 screened patients, 25% (n=180) developed clinically significant adverse effects. In the experimental group, mean pain score declined from 3.29±1.807 at baseline to 1.89±1.136 post-intervention (mean difference=1.40; t=6.89; df=89; p<0.001), representing a 43% reduction. In the control group, mean pain score decreased from 3.42±1.349 to 1.67±0.750 (mean difference=1.75; t=3.25; p=0.002). For bruising, the experimental group demonstrated a reduction from 2.46±0.889 to 1.77±0.720 (mean difference=0.69; t=7.23; p<0.001; 28% reduction), while the control group showed a modest reduction from 2.27±0.790 to 2.00±0.561 (mean difference=0.27; t=3.58; p<0.001). No significant association was found between pain and co-morbid conditions (χ²=7.504, df=9, p=0.585).

Conclusion: The structured nursing care package produced clinically and statistically significant reductions in both pain and bruising severity, with markedly superior bruising outcomes compared to routine care. This low-cost, easily trainable, evidence-based intervention warrants integration into standard nursing protocols for subcutaneous anticoagulant administration across Indian hospital settings.