Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients
Study Details
Study Description
Brief Summary
This study aims to evaluate the effect of cool baby oil on pruritus and sleep quality among uremic patient
Research Hypothesis:
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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
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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
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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
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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
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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
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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
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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
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Baby oil 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
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
|
| Placebo Comparator: Placebo 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
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
|
Outcome Measures
Primary Outcome Measures
- mean itching severity score at the baseline defined by Itching Severity Scale (ISS) [at the baseline (before assigning the participants to the study groups)]
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.
- change of the mean Itching Severity Scale (ISS) at 4 weeks [after 4 weeks from the baseline]
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.
- Change of the mean Itching Severity Scale (ISS) at 12 weeks [after 12 weeks from the baseline]
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.
- Mean pruritus severity Score on Visual Analog Scale at the Baseline [at the baseline (before assigning the participants to the study groups)]
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
- Change from baseline mean of the pruritus severity score on the Visual Analog Scale at 4 weeks [after 4 weeks from 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
- Change from baseline mean of the pruritus scores on the Visual Analog Scale at 12 weeks [after 12 weeks from 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
- Mean score of the sleep quality on the Pittsburgh sleep quality index at the baseline [at the baseline (before assigning the participants to the study groups)]
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 .
- Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 4 weeks [after 4 weeks from 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 .
- Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 12 weeks [after 12 weeks from 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 .
Secondary Outcome Measures
- socio-demographic and clinical data assessment tool [(before assigning the participants to the study groups)]
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.
- Related adverse Events [from starting of the intervention till 2 days after study completion]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Having three episodes of itching (each episode 5 min or longer) within the last 2 weeks
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Having intermittent itching complaints during the last 6 month
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Agreed to be on a fixed dose of the medical treatment throughout the study
Exclusion Criteria:
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Open wound
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Skin infection
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Edema
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History of allergic reaction to the oils
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Liver and dermatological diseases
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Usage of other treatment rather than the medical treatment on a regular basis 2 weeks prior to randomization and throughout the study
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Currently participating in other clinical trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dialysis Units of Almowasah University Hospital | Alexandria | Egypt | ||
| 2 | Dialysis Units of the Main University Hospital | Alexandria | Egypt |
Sponsors and Collaborators
- Alexandria University
Investigators
- Principal Investigator: Maha G Asal, Phd, Alexandria University
- Principal Investigator: Hoda A El-Deeb, Phd, Alexandria University
- Principal Investigator: Mona A Amer, Phd, Alexandria University
- Principal Investigator: Mervat A Hawash, Phd, Alexandria University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-9-43