Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Haemodialysis-Associated Pruritus

Intervention / Treatment
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* Other: Baby oil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-group pre-test and repeated post-test study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baby oil<br>A cool commercial baby oil at a temperature between 10°C and 15°C that composed of Paraffinum Liquidum, Isopropyl Palmitate, Parfumwill be applied to the affected area for a period of 15-20 min for three times a week before each hemodialysis session for 12 weeks. the baby oil bottle will be stored at the refrigerator. | Other: Baby oil<br>* 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<br>|
| Placebo Comparator: Placebo<br>A cool distilled water at a temperature between 10°C and 15°C with added two drops of the baby oil to each 100 cc will be applied to the affected area for a period of 15-20 min for three times a week before each hemodialysis session for 12 weeks. the distilled water will be put at an identical bottle as the baby oil bottle and stored at the refrigerator. | Other: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean itching severity score at the baseline defined by Itching Severity Scale (ISS) | this scale includes three items; (1) distribution of itching; (2) severity of itching; and (3) sleep disturbance caused by itching. Scores range 2-45. Increasing scores indicate increasing severity and intensity of itching. | at the baseline (before assigning the participants to the study groups) | 
| change of the mean Itching Severity Scale (ISS) at 4 weeks | this scale includes three items; (1) distribution of itching; (2) severity of itching; and (3) sleep disturbance caused by itching. Scores range 2-45. Increasing scores indicate increasing severity and intensity of itching. | after 4 weeks from the baseline | 
| Change of the mean Itching Severity Scale (ISS) at 12 weeks | this scale includes three items; (1) distribution of itching; (2) severity of itching; and (3) sleep disturbance caused by itching. Scores range 2-45. Increasing scores indicate increasing severity and intensity of itching. | after 12 weeks from the baseline | 
| Mean pruritus severity Score on Visual Analog Scale at the Baseline | This scale will be used to measure the itching intensity and consisting of a 10cm long line and a single question. The left end point represents no itch and the right end point the worst imaginable itch | at the baseline (before assigning the participants to the study groups) | 
| Change from baseline mean of the pruritus severity score on the Visual Analog Scale at 4 weeks | This scale will be used to measure the itching intensity and consisting of a 10cm long line and a single question. The left end point represents no itch and the right end point the worst imaginable itch | after 4 weeks from the baseline | 
| Change from baseline mean of the pruritus scores on the Visual Analog Scale at 12 weeks | This scale will be used to measure the itching intensity and consisting of a 10cm long line and a single question. The left end point represents no itch and the right end point the worst imaginable itch | after 12 weeks from the baseline | 
| Mean score of the sleep quality on the Pittsburgh sleep quality index at the baseline | it measure the self-rated sleep quality over the past month, and it is consisted of 19 self-rated question and 5 question rated by bed partner or roommate. Score ranges from 0 to 21. a score of > 5 indicate poor or difficult sleep and a score of ≤ 5 indicate good-sleep . | at the baseline (before assigning the participants to the study groups) | 
| Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 4 weeks | it measure the self-rated sleep quality over the past month, and it is consisted of 19 self-rated question and 5 question rated by bed partner or roommate. Score ranges from 0 to 21. a score of > 5 indicate poor or difficult sleep and a score of ≤ 5 indicate good-sleep . | after 4 weeks from the baseline | 
| Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 12 weeks | it measure the self-rated sleep quality over the past month, and it is consisted of 19 self-rated question and 5 question rated by bed partner or roommate. Score ranges from 0 to 21. a score of > 5 indicate poor or difficult sleep and a score of ≤ 5 indicate good-sleep . | after 12 weeks from the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| socio-demographic and clinical data assessment tool | this tool gathers data about participants' age, gender, educational level, marital status, area of residence, and occupation, duration of disease, comorbidity disease, duration of itching, Concurrent use of antihistamine for itching, period of most intense pruritus. | (before assigning the participants to the study groups) | 
| Related adverse Events | An unfavorable change in the health of a participants that happens during a clinical study or within a 2 days after the study has ended. This change may or may not be caused by the assigned treatment. | from starting of the intervention till 2 days after study completion |