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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baby oil | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby oil | Other | Before each application
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialysis Units of Almowasah University Hospital | Alexandria | Egypt | ||||
| Dialysis Units of the Main University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41437348 | Derived | Asal MGR, El-Deeb HAAE, Amer MAE, Hawash MAH. Cool baby oil for pruritus and sleep quality among uremic patients: a nurse-led randomized controlled trial. BMC Nurs. 2025 Dec 23;25(1):87. doi: 10.1186/s12912-025-03952-7. |
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It is not yet known if there will be a plan to make individual participant data available.
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two-group pre-test and repeated post-test study
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A two computer allocation sequence will be generated. They will be placed in an opaque, sealed envelope and kept with the head nurse of each hemodialysis unit. After completing the baseline data, the clinical researchers open the envelops and assign the patients to one group. The baby oil and the placebo distilled water will be placed on identical bottles and participants will not be informed about group assignments. The clinical researcher will label the groups as A or B; only the clinical researchers will know the group allocation. Both the outcome assessor and the statistician will be blinded.
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| Placebo | Other | Before each application
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| 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 |
| 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 |
| Alexandria |
| Egypt |