Effect of St. John's Wort Oil on Skin Moisture in Intensive Care Patients

August 7, 2024 updated by: Ayşenur ÖZENÇ KOLUTEK, Eskisehir Osmangazi University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Eskişehir, Turkey
        • Ayşenur ÖZENÇ KOLUTEK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: St. John's wort oil
To examine the effect of regularly applied St. John's Wort oil on skin moisture.
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.
Other: Barrier Cream
To examine the effect of regularly applied barrier cream on skin moisture.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşenur ÖZENÇ KOLUTEK, researcher, student of the institution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EskisehirOU-SBF-AOK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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