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
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
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
NCT ID
NCT05466045
First Posted
July 4, 2022
Last Updated
July 18, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Mackay Memorial Hospital
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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Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus and Sleep Disorders
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