Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus and Sleep Disorders

NCT05466045 | Unknown DMC

• 1 other identifier: 22MMHIS169e
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background and Purpose: Itching is a common complication of hemodialysis patients, which can cause skin damage and affect the patient's comfort. Studies have shown that olive oil is feasible and effective for pain relief, cancer treatment, stroke and cardiovascular disease, as well as wound healing and skin care because it is readily available, natural, and has merely no side effects, and there is no research application on the skin itchiness in hemodialysis patients. The purpose of this study was to investigate the effect of applying extra virgin olive oil to improve skin itching, sleep quality and changes in heart rate variability in hemodialysis patients. Research method: This study is designed as a randomized controlled trial (RCT), which is divided into two groups, the experimental group and the control group. Before the interventional measures, a questionnaire pre-test and HRV test are given first, and the interventional measures are given. During the period, in addition to routine care, both groups of patients used a brown roller ball glass bottle containing extra virgin olive oil or normal saline on the itchy skin every 12 hours gently and evenly smeared with fingers , for 28 days, and on the 14th day and 28 days.After intervention, the post-questionnaire test and HRV test were carried out. The research tools include: 5-D 5-D itch scale, Visual Analogue Scale (VAS), Pittsburgh Sleep Quality Index (PSQI) and Heart Rate Variability (HRV) detector.The data collection results were archived with Statistical Package for the Social Sciences (SPSS) statistical software, and the data were processed and analyzed by descriptive statistics, chi-square test, generalized estimating equation (GEE) and independent sample t test. Expected results: Result showed using extra virgin olive oil can improvement of skin itchiness and sleep quality in hemodialysis patients, and also cost effectiveness of lotions , reduction of drugs burden on kidneys and improvement of patients' quality of life.

Conditions

Uremic Pruritus

Keywords

Pruritus; Hemodialysis; End-stage renal disease (ESRD); Extra virgin olive oil

Outcome Measures

Primary Outcomes (2)

• Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus

  change of Pruritus

  the 1th ,14th, 28th day

• Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve

  change of Sleep quality

  the 1th ,14th, 28th day

Study Arms (2)

experimental group

EXPERIMENTAL

Experimental group received olive oil application

Other: Olive oil application in hemodialysis patients with pruritus

control group

PLACEBO COMPARATOR

Control group received normal saline application

Other: Normal saline application in hemodialysis patients with pruritus

Interventions

Olive oil application in hemodialysis patients with pruritus OTHER

Experimental group: In addition to routine care, a brown glass bottle containing extra virgin olive oil was applied on the itchy skin every 12 hours by rubbing (after washing the patient's face in the morning and after dinner). The intervention duration was 28 days.

experimental group

Normal saline application in hemodialysis patients with pruritus OTHER

Control group: In addition to routine care, a brown glass bottle containing normal saline was applied on the itchy skin every 12 hours by rubbing (after washing the patient's face in the morning and after dinner). The intervention duration was 28 days.

control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ESRD ,Regular hemodialysis patients \>3 months

You may not qualify if:

• allergic patients
• skin infection
• atopic dermatitis

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Mackay Memorial Hospital: collaborator

MeSH Terms

Conditions

Pruritus; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• mei-hua pan, master

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mei-hua pan, master

CONTACT

+8860963653706; qq5612@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 20, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share