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

NCT06737484 | Completed

• 1 other identifier: INONU-SBE-KC-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis Patients; Pruritus

Keywords

Hemodialysis; Nursing; Olive Oil; Pruritus

Outcome Measures

Primary Outcomes (2)

• PRURITUS SEVERITY

  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.

  14 DAYS

• Pruritus complaints

  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.

  14 DAYS

Study Arms (2)

Experimental group

EXPERIMENTAL

Hemodialysis patient with pruritus who will be treated with olive oil

Other: APPLYING TOPICAL OLIVE OIL

Control group

NO INTERVENTION

Hemodialysis patient with pruritus who will not undergo any intervention

Interventions

APPLYING TOPICAL OLIVE OIL OTHER

1. Preparation phase: Before the application, hand hygiene will be provided, materials will be prepared, and the application will be carried out wearing gloves. The patient bed will be prepared, a stretcher cover and a bed protector will be laid. A screen will be used for patient privacy and only the areas to be applied will be opened in order. Itchy areas will be identified. Before starting the application, olive oil will be tested by applying it to a small area on the inside of the patient's arm in case of any allergic reaction. 2. Application of olive oil: 3 drops of olive oil will be dropped on the itchy areas (excluding the scalp and private areas) for every 25 cm square area and gently spread over the area for 30-60 seconds. Since there is a 5-7 minute absorption period from the skin, the area will be kept open and then a VAS score will be taken. 3. After the application: The procedure will be marked on the patient follow-up form.

Experimental group

Eligibility Criteria

• Age: 18 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead
• Kahramanmaras Sutcu Imam University: collaborator

Study Sites (1)

Kahramanmaraş Sütçü İmam Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi

Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: January 27, 2025
• Primary Completion: February 16, 2025
• Study Completion: July 15, 2025
• Last Updated: September 12, 2025

Record last verified: 2024-12

Locations

TU (1)