Background <p>Uremic pruritus (UP) is a prevalent and debilitating condition among patients undergoing hemodialysis that significantly impairs sleep quality and overall well-being. Despite its complex, multifactorial pathophysiology, effective management of pruritus remains challenging. Baby oil, known for its moisturizing properties, has been suggested as a potential intervention for alleviating pruritus. However, existing studies have focused primarily on its short-term effects, leaving a gap in understanding its sustained impact. This study aimed to evaluate the effects of cool paraffin-based baby oil massage on pruritus severity and sleep quality in hemodialysis patients over four and twelve weeks compared with those of a placebo.</p> Methods <p>This parallel-group, randomized, double-blind (participant and outcome evaluators), placebo-controlled trial involved 82 adults, randomized to either the baby oil group (<i>n</i> = 41), which received massage with commercial cool paraffin-based baby oil, or the placebo group (<i>n</i> = 41), which received massage with 10&#xa0;cc of cool distilled water mixed with two drops of oil. The trial was conducted in two hemodialysis centers over a 12-week treatment period beginning in October 2022. The primary outcomes included pruritus severity, which was assessed via the Itching Severity Scale (ISS) and Pruritus Visual Analogue Scale (PVAS), and sleep quality, which was measured via the Pittsburgh Sleep Quality Index (PSQI).</p> Results <p>A total of 80 participants (40 in each group) were analysed. Compared with the placebo group, the baby oil group presented significantly greater reductions in pruritus severity, with mean differences of 8.70 (<i>p</i> = 0.03, d = 1.32) at 4 weeks and 10.03 (<i>p</i> &lt; 0.01, d = 2.58) at 12 weeks for the ISS. For the PVAS, the mean difference was 1.83 (<i>p</i> &lt; 0.01, d = 1.06) at 4 weeks and 4.42 (<i>p</i> &lt; 0.01, d = 3.57) at 12 weeks. Sleep quality also improved significantly, with mean differences of 2.57 (<i>p</i> &lt; 0.01, d = 0.97) at 4 weeks and 5.75 (<i>p</i> &lt; 0.01, d = 2.95) at 12 weeks.</p> Conclusion <p>Paraffin-based cool baby oil massage is an effective intervention for reducing pruritus severity and improving sleep quality among hemodialysis patients with UP. This simple intervention can be easily incorporated into nursing care plans, offering a practical approach to enhancing patient comfort and quality of life. By alleviating pruritus and promoting better sleep, it has the potential to significantly improve the well-being of patients with end-stage renal disease undergoing hemodialysis.</p> Trial registration <p>This study was prospectively registered as a randomized controlled trial at ClinicalTrials.gov (Registration ID: NCT05555524) on September 22, 2022. The full trial details are available at <a href="https://clinicaltrials.gov/">https://clinicaltrials.gov/</a>.</p>