Effect of Cool Baby Oil on Pruritus and Sleep Quality Among Uremic Patients: a Double-blind Placebo-controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- mean itching severity score at the baseline defined by Itching Severity Scale (ISS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Open wound
- •Skin infection
- •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
研究组 & 干预措施
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.
干预措施: Baby oil (Other)
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.
干预措施: Placebo (Other)
结局指标
主要结局
mean itching severity score at the baseline defined by Itching Severity Scale (ISS)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 .
次要结局
- socio-demographic and clinical data assessment tool((before assigning the participants to the study groups))
- Related adverse Events(from starting of the intervention till 2 days after study completion)
研究者
Maha Gamal Ramadan Asal
Principle investigator
Alexandria University