- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06545422
Effect of St. John's Wort Oil on Skin Moisture in Intensive Care Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eskişehir, Turkey
- Ayşenur ÖZENÇ KOLUTEK
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
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. |
To examine the effect of regularly applied St. John's Wort oil on skin moisture.
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|
Other: Control Group
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. |
To examine the effect of regularly applied barrier cream on skin moisture.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Moisture measurement of the coccyx area was performed with a skin moisture meter.
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Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.
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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.
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Moisture measurement of the coccyx area was performed with a skin moisture meter.
|
Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşenur ÖZENÇ KOLUTEK, researcher, student of the institution
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EskisehirOU-SBF-AOK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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