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Clinical Trial Summary

This study aims to evaluate the effect of cool baby oil on pruritus and sleep quality among uremic patient Research Hypothesis: - H01: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding sleep quality at 4 weeks follow-up - H02: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding itching severity at 4 weeks follow-up - H03: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding sleep quality at 12 weeks follow up - H04: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding itching severity at 12 weeks follow up - H1: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit improved sleep quality than those who apply placebo at 4 weeks follow up - H2: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit decreased itching severity than those who apply placebo at 4 weeks follow up - H3: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit improved sleep quality than those who apply placebo at 12 weeks follow up - H4: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit decreased itching severity than those who apply placebo at 12 weeks follow up


Clinical Trial Description

Treatment of uremic pruritus is difficult due to the refractory nature of the disease, resulting in poor hemodialysis patient quality of life, pharmacological therapy is the most common clinical treatment method. Unfortunately, despite these interventions, pruritus remains a chronic problem for many dialysis patients. Recently, non-pharmacological interventions are effective for hemodialysis patients with uremic pruritus. Emollients that include Petrolatum, lanolin, mineral oil, and dimethicone were very effective, readily available, and cost-effective interventions in comparison to other methods to improve pruritus symptoms. Several studies have been conducted and show the efficiency of baby oil in controlling pruritus and enhancing sleep quality among hemodialysis patients. However these studies evaluate the short-term effect (4 weeks), Although these studies employed usual care, no-treatment group as the control condition, thus it was not possible to blind the participants. This type of control group would likely increase treatment effects from baby oil by comparison. Thus the current study will be conducted to evaluate the effect of baby oil on pruritus and sleep quality compared to a placebo control at 4 and 12 weeks followup. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05555524
Study type Interventional
Source Alexandria University
Contact
Status Completed
Phase N/A
Start date October 2, 2022
Completion date January 12, 2023