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临床试验/NCT06737484
NCT06737484已完成不适用

Effect of Topically Applied Olive Oil on Pruritus in Hemodialysis Patients: Pretest-posttest Model With Control Group

Inonu University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年1月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
PRURITUS SEVERITY

研究概览

简要总结

Pruritus is one of the common symptoms and complaints in hemodialysis patients. The studies reviewed demonstrated that a number of nonpharmacological interventions are effective in relieving pruritus in hemodialysis patients. Among these interventions, moisturizers were found to be highly effective. This clinical trial study was planned considering that the moisturizing and anti-inflammatory properties of olive oil, which will help relieve skin dryness and inflammation that play a role in the pathogenesis of itching, will be effective in solving the itching problem.

Objective: To evaluate the effect of topically applied olive oil on pruritus in hemodialysis patients.

Research Hypotheses:

H0: Topically applied olive oil has no effect on pruritus in hemodialysis patients.

H1: Topically applied olive oil has an effect on pruritus in hemodialysis patients.

Research Type:

The study was planned to be conducted as an experimental study with a pre-test and post-test control group.

Method: The research will be carried out as an experimental study with pre-test and post-test control groups at the KSÜ Health Practice and Research Hospital Hemodialysis Unit and the Turkish Kidney Foundation KSÜ Dialysis Center between 03/02/2025-01/04/2025, the universe will be hemodialysis patients receiving treatment at the hemodialysis unit of the relevant hospital, the sample will consist of a total of 68 patients, 34 experimental and 34 control groups, as a result of power analysis. Data collection tools: Personal Information Form, 5-D Itch Scale, Visual Analog Scale (VAS), Blood values. In the experimental group, olive oil will be applied to the itchy areas of the patients by the researcher on the days they come for hemodialysis, 3 days a week for 2 weeks. Patients will apply olive oil to themselves at home on the days they do not come to dialysis. Pre-test data will be collected from both groups in the first interview. Subsequently, VAS scores of the experimental group will be taken before and after each application. No application will be made to the control group and VAS scores will be taken on the day they come to dialysis. Post-test data will be collected from patients in the experimental and control groups at the end of 2 weeks using the 5-D Itch Scale.

Originality: The absence of any experimental study in the literature using pure olive oil in the management of itching in hemodialysis patients constitutes the strength and originality of the study.

Expected results: Topical olive oil application is expected to be effective in reducing frequent itching complaints in hemodialysis patients.

详细描述

Chronic renal failure (CRF); is a condition that progresses with a progressive and irreversible decrease in glomerular filtration rate and nephron damage, disrupting the body's endocrine, metabolic and fluid-electrolyte balance. One of the methods of hemodialysis, peritoneal dialysis and kidney transplantation is required in the treatment of chronic renal failure. The most commonly used of these treatment methods is hemodialysis. Hemodialysis is a treatment method that regulates the fluid and solute balance of the blood taken from the patient through a machine containing a membrane. While the impaired renal functions of the patients are partially corrected with hemodialysis, significant complications also occur in many organs and systems. The most common problem related to the skin of these complications is pruritus. Pruritus is an unpleasant sensory and emotional experience that creates a scratching and rubbing sensation on the skin. Pruritus occurs continuously or intermittently in the form of attacks, widespread throughout the body or localized to a certain area, and occurs most frequently in the head, back, limbs and chest. In the pathogenesis of pruritus; skin dryness, proliferation of mast cells in the skin, release of proinflammatory cytokines such as C-Reactive protein (CRP) and interleukin-6 (IL-6), iron deficiency, dialysis-related allergic reactions, hypersensitivity, hypercalcemia, hyperphosphatemia, increased histamine, drugs, neuropathy, opioid system involvement, secondary hyperparathyroidism, increased serum vitamin A levels, serum bile acids, and uremic toxins play a role. Patients experiencing pruritus experience problems such as fatigue, sleep problems, anxiety, depression, social isolation, and aesthetic concerns, which reduce quality of life and personal care and make adaptation to the disease difficult. Secondary skin changes such as lesions, bleeding, delayed wound healing, mechanical skin damage, and infection may be observed in patients due to pruritus. Since the pathophysiology of pruritus is multifactorial and not fully understood, partially effective treatments are available. Studies have shown that many non-pharmacological interventions are effective in relieving pruritus in hemodialysis patients. Among these interventions, moisturizers have been found to be highly effective.

Olive oil is a product that can be easily absorbed from the skin, prevents fluid loss by accelerating the proliferation of the epidermis, increases the softness of the skin and thus moisturizes the skin and gives it elasticity, and has been widely used in skin care in recent years. A compound called oleocanthal, which forms the basis of the effects of nonsteroidal anti-inflammatory drugs and analgesics, has been identified in olive oil. Olive oil contains; antioxidant effect with vitamin E, increasing intravascular endothelial growth factor (VEGF) levels with phenolic compounds, photoprotection, anti-inflammatory, antimicrobial and antiaging effect, moisturizing effect with squalene, cell repair effect with oleic acid and linoleic acid, which has properties similar to breast milk. Since olive oil is completely compatible with human tissue cells thanks to its lipid composition, it is unlikely to cause an allergic reaction when applied to the skin, does not show any cytotoxic effect, and is an easy-to-obtain and use product.

Symptom management has an important place in nursing services. According to studies, pruritus is one of the most common symptoms and complaints in hemodialysis patients, more than half of the patients experience pruritus. Nurses should develop evidence-based solutions to reduce pruritus symptoms in hemodialysis patients and prevent secondary problems that may occur due to pruritus. This study was planned considering that olive oil's moisturizing and anti-inflammatory properties, which will help relieve skin dryness and inflammation, which play a role in the pathogenesis of pruritus, will be effective in solving the pruritus problem.

METHOD

Purpose of the Study:

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
None

入排标准

年龄范围
18 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Volunteering to participate in the study
  • •Being over 18 years of age
  • •Not having a psychiatric problem
  • •Not having a vision, hearing or speech problem
  • •Knowing Turkish, being open to communication and cooperation
  • •Receiving hemodialysis treatment for at least 6 months
  • •Having three pruritus attacks in the last 2 weeks (each attack lasting 5 minutes or longer) or having intermittent pruritus complaints in the last 6 months
  • •Not having any open wound, cellulitis, infection, deep vein thrombosis, bleeding, paraplegia or pacemaker in the area to be applied
  • •Not being allergic to olive oil
  • •Not applying any not using topical medication, moisturizer etc.
  • •Not using any traditional complementary alternative treatment method on the pruritus area

排除标准

  • •Not wanting to participate in the study
  • •Being under the age of 18
  • •Having a psychiatric problem
  • •Having a vision, hearing or speech problem
  • •Not knowing Turkish, not being open to communication and cooperation
  • •Not receiving hemodialysis treatment for at least 6 months
  • •Not defining an pruritus complaint
  • •Having any open wound, cellulitis, infection, deep vein thrombosis, bleeding, paraplegia or pacemaker in the area to be applied
  • •Being allergic to olive oil
  • •Not applying any topical medication, moisturizer etc. to the itchy area product use
  • •Using any traditional complementary alternative treatment method on the pruritus area

研究组 & 干预措施

Experimental group

Experimental

Hemodialysis patient with pruritus who will be treated with olive oil

干预措施: APPLYING TOPICAL OLIVE OIL (Other)

Control group

No Intervention

Hemodialysis patient with pruritus who will not undergo any intervention

结局指标

主要结局

PRURITUS SEVERITY

时间窗: 14 DAYS

It will be evaluated with VAS. Visual Analog Scale (VAS): VAS is a scale developed by Huskisson to convert some values that cannot be measured numerically into numerical form. The two extreme definitions of the parameter to be evaluated are written on both ends of a 10 cm line and the patient is asked to indicate where their own situation fits on this line by drawing a line, putting a dot or pointing. The average of the values obtained for the patients is taken in the evaluation. In this study, a form with a 10 cm long line written on one end as "no pruritus" (0) and "very severe pruritus" (10) on the other will be given to determine the severity of pruritus, and the patient will be asked to mark their own condition on this line. The length of the distance from the place where there is no pruritus to the point marked by the patient will be measured with a standard ruler to determine the severity of the patient's pruritus.

Pruritus complaints

时间窗: 14 DAYS

It will be evaluated with the 5-D Itch Scale. The 5-D Itch Scale was developed by Elman, Hyman, Gabriel and Mayo in 2010. The scale consists of 5 sub-dimensions and 8 variables, namely duration, severity, course, area of restriction and distribution of pruritus in the body. It is a scale that provides information about the severity, duration, course of pruritus, its effects on sleep, housework/daily tasks, school/work, social life/leisure activities and the areas where it is seen on the body. The scale can be scored between a minimum of 5 (no itching) and a maximum of 25 points (itching at its highest level). While the duration, severity, course and restriction area of pruritus from the scale sub-dimensions are scored between 1 and 5 points; the distribution in the body is scored by examining a total of 16 body parts and scoring 5 points according to the number of body parts affected, as 0-2=1 point, 3-5=2 points, 6-10=3 points, 11-13=4 points and 14-16=5 points.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Çırak

Lecturer

Inonu University

研究点 (1)

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