NCT05555524

Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients

Effect of Cool Baby Oil on Pruritus and Sleep Quality Among Uremic Patients: a Double-blind Placebo-controlled Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Haemodialysis-Associated Pruritus

Interventions

Type	Name	Description
OTHER	Baby oil	Before each application * Hand hygiene will be done * Skin care will be done to the affected area and the area is thoroughly dried. * Participants will wear a hospital gown and seated comfortably on their bed. * Gentle massage with the cool baby oil will be applied on the itching area and is continued for 15-20 min. * Message will be applied for three times a week before each hemodialysis session for 12 weeks
OTHER	Placebo	Before each application * Hand hygiene will be done * Skin care will be done to the affected area and the area is thoroughly dried. * Participants will wear a hospital gown and seated comfortably on their bed. * Gentle massage with the cool distilled water will be applied on the itching area and is continued for 15-20 min. * Message will be applied for three times a week before each hemodialysis session for 12 weeks

Timeline

• Start date: 2022-10-02
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2022-09-27
• Last updated: 2023-01-17

Locations

2 sites across 1 country: Egypt