Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05555524
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2022-09-22
Brief Title:
Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Effect of Cool Baby Oil on Pruritus and Sleep Quality Among Uremic Patients a Double-blind Placebo-controlled Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None