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

Primary Purpose

Uremic Pruritus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Olive oil application in hemodialysis patients with pruritus
Normal saline application in hemodialysis patients with pruritus
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Uremic Pruritus focused on measuring Pruritus, Hemodialysis, End-stage renal disease (ESRD), Extra virgin olive oil

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ESRD ,Regular hemodialysis patients >3 months

Exclusion Criteria:

  • allergic patients
  • skin infection
  • atopic dermatitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    experimental group

    control group

    Arm Description

    Experimental group received olive oil application

    Control group received normal saline application

    Outcomes

    Primary Outcome Measures

    Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus
    change of Pruritus
    Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve
    change of Sleep quality

    Secondary Outcome Measures

    Full Information

    First Posted
    July 4, 2022
    Last Updated
    July 18, 2022
    Sponsor
    National Taipei University of Nursing and Health Sciences
    Collaborators
    Mackay Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05466045
    Brief Title
    Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus and Sleep Disorders
    Official Title
    Using of Extra Virgin Olive Oil in Patient With Hemodialysis to Improve the Effect of Pruritus and Sleep Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taipei University of Nursing and Health Sciences
    Collaborators
    Mackay Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Background and Purpose: Itching is a common complication of hemodialysis patients, which can cause skin damage and affect the patient's comfort. It will not only affect social activities, but also affect the quality of life. In severe cases, it will cause sleep disorders. 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 no side effects, and there is no research application on the skin itchiness in hemodialysis patients.Therefore 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. The research process is divided into three stages. Before the interventional measures, a questionnaire pre-test and HRV test are given first.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. Questionnaire and HRV test were carried on the 14th day .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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uremic Pruritus
    Keywords
    Pruritus, Hemodialysis, End-stage renal disease (ESRD), Extra virgin olive oil

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Experimental group received olive oil application
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    Control group received normal saline application
    Intervention Type
    Other
    Intervention Name(s)
    Olive oil application in hemodialysis patients with pruritus
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Normal saline application in hemodialysis patients with pruritus
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus
    Description
    change of Pruritus
    Time Frame
    the 1th ,14th, 28th day
    Title
    Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve
    Description
    change of Sleep quality
    Time Frame
    the 1th ,14th, 28th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ESRD ,Regular hemodialysis patients >3 months Exclusion Criteria: allergic patients skin infection atopic dermatitis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mei-hua pan, master
    Phone
    +8860963653706
    Email
    qq5612@yahoo.com.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    mei-hua pan, master
    Organizational Affiliation
    Mackay Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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