Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05466045 |
| Other study ID # |
22MMHIS169e |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
National Taipei University of Nursing and Health Sciences |
| Contact |
mei-hua pan, master |
| Phone |
+8860963653706 |
| Email |
qq5612[@]yahoo.com.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
