Clinical trial NCT05555524: Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients
Official title: Effect of Cool Baby Oil on Pruritus and Sleep Quality Among Uremic Patients: a Double-blind Placebo-controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemodialysis-Associated Pruritus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-group pre-test and repeated post-test study
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: Inclusion Criteria:

* Having three episodes of itching (each episode 5 min or longer) within the last 2 weeks
* Having intermittent itching complaints during the last 6 month
* Agreed to be on a fixed dose of the medical treatment throughout the study

Exclusion Criteria:

* Open wound
* Skin infection
* Edema
* History of allergic reaction to the oils
* Liver and dermatological diseases
* Usage of other treatment rather than the medical treatment on a regular basis 2 weeks prior to randomization and throughout the study
* Currently participating in other clinical trials

Primary outcomes:
measure: mean itching severity score at the baseline defined by Itching Severity Scale (ISS)
timeFrame: at the baseline (before assigning the participants to the study groups)
measure: change of the mean Itching Severity Scale (ISS) at 4 weeks
timeFrame: after 4 weeks from the baseline
measure: Change of the mean Itching Severity Scale (ISS) at 12 weeks
timeFrame: after 12 weeks from the baseline
measure: Mean pruritus severity Score on Visual Analog Scale at the Baseline
timeFrame: at the baseline (before assigning the participants to the study groups)
measure: Change from baseline mean of the pruritus severity score on the Visual Analog Scale at 4 weeks
timeFrame: after 4 weeks from the baseline
measure: Change from baseline mean of the pruritus scores on the Visual Analog Scale at 12 weeks
timeFrame: after 12 weeks from the baseline
measure: Mean score of the sleep quality on the Pittsburgh sleep quality index at the baseline
timeFrame: at the baseline (before assigning the participants to the study groups)
measure: Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 4 weeks
timeFrame: after 4 weeks from the baseline
measure: Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 12 weeks
timeFrame: after 12 weeks from the baseline
Secondary outcomes:
measure: socio-demographic and clinical data assessment tool
timeFrame: (before assigning the participants to the study groups)
measure: Related adverse Events
timeFrame: from starting of the intervention till 2 days after study completion
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Dialysis Units of Almowasah University Hospital
city: Alexandria
country: Egypt
facility: Dialysis Units of the Main University Hospital
Study officials:
affiliation: Alexandria University
name: Maha G Asal, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Hoda A El-Deeb, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Mona A Amer, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Mervat A Hawash, Phd
role: PRINCIPAL_INVESTIGATOR
References: