Uremic PruritusNCT05466045
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus and Sleep Disorders
A study testing Olive oil application in hemodialysis patients with pruritus and Normal saline application in hemodialysis patients with pruritus in people with Uremic Pruritus, run by National Taipei University of Nursing and Health Sciences.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Olive oil application in hemodialysis patients with pruritus and Normal saline application in hemodialysis patients with pruritus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD ,Regular hemodialysis patients >3 months
Who cannot join
- allergic patients
- skin infection
- atopic dermatitis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Using of Extra Virgin Olive Oil in Patient With Hemodialysis to Improve the Effect of Pruritus and Sleep Disorders
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.
Read more
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.
Read the 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.
- Conditions
- Uremic Pruritus
- Being tested
- Olive oil application in hemodialysis patients with pruritus, Normal saline application in hemodialysis patients with pruritus
- Keywords
- Pruritus, Hemodialysis, End-stage renal disease (ESRD), Extra virgin olive oil
- Medical subject headings
- Pruritus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive oil application in hemodialysis patients with pruritusOther
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.
Normal saline application in hemodialysis patients with pruritusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Experimental group received olive oil application Receives: Other: Olive oil application in hemodialysis patients with pruritus |
| control group | Placebo comparator | Control group received normal saline application Receives: Other: Normal saline application in hemodialysis patients with pruritus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus
change of Pruritus
Measured: the 1th ,14th, 28th day
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve
change of Sleep quality
Measured: the 1th ,14th, 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Responsible party
- Principal investigator, Mei-Hua, Pan, National Taipei University of Nursing and Health Sciences
- Investigators
- mei-hua pan, master, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466045
- Sponsor's protocol ID
- 22MMHIS169e
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using of Extra Virgin Olive Oil in Patient With Hemodialysis to Improve the Effect of Pruritus and Sleep Disorders
- ClinicalTrials.gov ID
- NCT05466045
- Acronym / sponsor ID
- 22MMHIS169e
- Conditions
- Uremic Pruritus
- Keywords
- Pruritus, Hemodialysis, End-stage renal disease (ESRD), Extra virgin olive oil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Mackay Memorial Hospital
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Olive oil application in hemodialysis patients with pruritusExperimental group received olive oil application |
| control group | Placebo comparator | Other: Normal saline application in hemodialysis patients with pruritusControl group received normal saline application |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESRD ,Regular hemodialysis patients >3 months
Key exclusion criteria (3 listed)
- allergic patients
- skin infection
- atopic dermatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive oil application in hemodialysis patients with pruritusExperimental 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. | Other | experimental group |
| Normal saline application in hemodialysis patients with pruritusControl 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. | Other | control group |
Primary outcome
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus
Time frame: the 1th ,14th, 28th day
change of Pruritus
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve
Time frame: the 1th ,14th, 28th day
change of Sleep quality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Uremic Pruritus
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mei-hua pan, master principal investigator
Mackay Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Olive oil application in hemodialysis patients with pruritus and Normal saline application in hemodialysis patients with pruritus in people with Uremic Pruritus, run by National Taipei University of Nursing and Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mei-hua pan, master (+8860963653706, qq5612@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using of Extra Virgin Olive Oil in Hemodialysis Patients to Improve Pruritus (time frame: the 1th ,14th, 28th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.