Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05466045
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-07-04
Brief Title:
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus and Sleep Disorders
Sponsor:
National Taipei University of Nursing and Health Sciences
Organization:
National Taipei University of Nursing and Health Sciences
Study Overview
Official Title:
Using of Extra Virgin Olive Oil in Patient With Hemodialysis to Improve the Effect of Pruritus and Sleep Disorders
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background and Purpose
Itching is a common complication of hemodialysis patients which can cause skin damage and affect the patients 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 daysAfter 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 detectorThe 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
Itching is a common complication of hemodialysis patients which can cause skin damage and affect the patients 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 daysAfter 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 detectorThe 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 patients 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 patientsTherefore 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 firstThe 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 detectorThe 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
Itching is a common complication of hemodialysis patients which can cause skin damage and affect the patients 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 patientsTherefore 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 firstThe 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 detectorThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None