Skin MoistureNCT06545422
Effect of St. John's Wort Oil on Skin Moisture in Intensive Care Patients
A study testing St. John's wort oil and Barrier Cream in people with Skin Moisture, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.It has been observed that St. John's wort oil has an effect on the skin moisture of intensive care patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Moisture
- What is being tested?
- St. John's wort oil and Barrier Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Mar 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admission to intensive care due to internal diseases diagnosis
- The patient is immobile
- The area to be applied is determined as the Coccyx and the tissue in this area must be intact.
- No allergy to St. John's Wort oil
- No circulatory disorders in the applied area
Who cannot join
- Having a complicated diagnosis such as cancer
- Having any disease that has spread to the entire skin
- Having an allergy to topical medications or plant extracts
- The patient has different variations such as surgical operation and intensive care change (post-operative follow-up patient)
- The patient has a diagnosis of a skin disease such as dermatitis
- A wound in the coccyx area
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.It has been observed that St. John's wort oil has an effect on the skin moisture of intensive care patients.
Read the detailed description
Effect of St. John's Wort oil on skin moisture in intensive care patients.
The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.
Research data was collected at Eskisehir City Hospital, between September 1, 2023 and March 1, 2024. Descriptive Characteristics Form, Braden Risk Assessment Scale, Moisture Meter Device and St. John's wort oil were used to collect data. In the sample size power analysis of the study, the total number of samples was found to be 138 with test power ( 1-β) 0.80, α(alpha)=0.05, effect level 0.10. The research was conducted on a total of 140 patients, 70 in the experimental group and 70 in the control group. St. John's wort oil was applied to the experimental group and routine nursing care was applied to the control group for 21 days. Independent Sample t test, ANOVA (Repeated Measures test), Mann- Whitney U test, Wilcoxon test and Pearson-χ 2 cross tables were used to evaluate the data.
- Conditions
- Skin Moisture
- Being tested
- St. John's wort oil, Barrier Cream
- Keywords
- skin moisture, pressure ulcer, nursing, St. John's wort oil
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. John's wort oilOther
To examine the effect of regularly applied St. John's Wort oil on skin moisture.
Barrier CreamOther
To examine the effect of regularly applied barrier cream on skin moisture.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 70 experimental group patients participated in the study; St. John's wort oil was applied to the coccyx area(width 10cm, length 10cm) of the patient included in the study at the same times every day for 21 days, starting from Day 0.
The first day of hospitalization is considered day 0 and skin moisture is measured. The skin is cleaned and dried. 4 or 5 drops of St. John's wort oil were dropped onto the area and applied with a cotton pad.The next day, skin moisture is measured then the skin is cleaned and dried and St. John's wort oil is applied again. This Process continues for 21 days and is recorded. Receives: Other: St. John's wort oil |
| Control Group | Other | 70 control group patients participated in the study; The skin protective barrier cream used in routine care of the coccyx region (width 10 cm, length 10 cm) of the patient included in the study was applied at the same hours every day for 21 days, starting from day 0.
The first day of hospitalization is considered day 0 and skin moisture is measured. The skin is cleaned and dried.Barrier cream is applied to the patient's coccyx area.The next day, at the same time, skin moisture is measured, then the skin is cleaned and dried, and barrier cream is applied again.Transactions are made and recorded every day for 21 days. Receives: Other: Barrier Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experimental Group Results
Moisture measurement of the coccyx area was performed with a skin moisture meter.
Measured: Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.
Control Group Results
Moisture measurement of the coccyx area was performed with a skin moisture meter.
Measured: Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin MoistureStudies 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
- Model description
- Prospective pretest-posttest controlled study
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur ÖZENÇ KOLUTEK, Eskisehir Osmangazi University
- Investigators
- Ayşenur ÖZENÇ KOLUTEK, researcher, Principal investigator, student of the institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545422
- Sponsor's protocol ID
- EskisehirOU-SBF-AOK-01
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of St. John's Wort Oil on Skin Moisture in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06545422
- Acronym / sponsor ID
- EskisehirOU-SBF-AOK-01
- Conditions
- Skin Moisture
- Keywords
- skin moisture, pressure ulcer, nursing, St. John's wort oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 9 Aug 2024 (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.
The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.It has been observed that St. John's wort oil has an effect on the skin moisture of intensive care patients.
Detailed description
Effect of St. John's Wort oil on skin moisture in intensive care patients.
The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.
Research data was collected at Eskisehir City Hospital, between September 1, 2023 and March 1, 2024. Descriptive Characteristics Form, Braden Risk Assessment Scale, Moisture Meter Device and St. John's wort oil were used to collect data. In the sample size power analysis of the study, the total number of samples was found to be 138 with test power ( 1-β) 0.80, α(alpha)=0.05, effect level 0.10. The research was conducted on a total of 140 patients, 70 in the experimental group and 70 in the control group. St. John's wort oil was applied to the experimental group and routine nursing care was applied to the control group for 21 days. Independent Sample t test, ANOVA (Repeated Measures test), Mann- Whitney U test, Wilcoxon test and Pearson-χ 2 cross tables were used to evaluate the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective pretest-posttest controlled study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: St. John's wort oil70 experimental group patients participated in the study; St. John's wort oil was applied to the coccyx area(width 10cm, length 10cm) of the patient included in the study at the same times every day for 21 days, starting from Day 0. The first day of hospitalization is considered day 0 and skin moisture is measured. The skin is cleaned and dried. 4 or 5 drops of St. John's wort oil were dropped onto the area and applied with a cotton pad.The next day, skin moisture is measured then the skin is cleaned and dried and St. John's wort oil is applied again. This Process continues for 21 days and is recorded. |
| Control Group | Other | Other: Barrier Cream70 control group patients participated in the study; The skin protective barrier cream used in routine care of the coccyx region (width 10 cm, length 10 cm) of the patient included in the study was applied at the same hours every day for 21 days, starting from day 0. The first day of hospitalization is considered day 0 and skin moisture is measured. The skin is cleaned and dried.Barrier cream is applied to the patient's coccyx area.The next day, at the same time, skin moisture is measured, then the skin is cleaned and dried, and barrier cream is applied again.Transactions are made and recorded every day for 21 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Admission to intensive care due to internal diseases diagnosis
- The patient is immobile
- The area to be applied is determined as the Coccyx and the tissue in this area must be intact.
- No allergy to St. John's Wort oil
- No circulatory disorders in the applied area
Key exclusion criteria (6 listed)
- Having a complicated diagnosis such as cancer
- Having any disease that has spread to the entire skin
- Having an allergy to topical medications or plant extracts
- The patient has different variations such as surgical operation and intensive care change (post-operative follow-up patient)
- The patient has a diagnosis of a skin disease such as 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 |
|---|---|---|
| St. John's wort oilTo examine the effect of regularly applied St. John's Wort oil on skin moisture. | Other | Experimental group |
| Barrier CreamTo examine the effect of regularly applied barrier cream on skin moisture. | Other | Control Group |
Primary outcome
Experimental Group Results
Time frame: Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.
Moisture measurement of the coccyx area was performed with a skin moisture meter.
Control Group Results
Time frame: Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.
Moisture measurement of the coccyx area was performed with a skin moisture meter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Ayşenur ÖZENÇ KOLUTEK, researcher principal investigator
student of the institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing St. John's wort oil and Barrier Cream in people with Skin Moisture, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experimental Group Results (time frame: Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.). 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 9 Aug 2024.