- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05716711
Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals With Colostomy (surgery)
January 27, 2023 updated by: dudu alptekin, Cukurova University
The Effect of Different Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals With Colostomy
This study was planned to examine the effects of using the lavender essential oil and peppermint essential oil in stoma bags on odor removal, life satisfaction, and stoma compliance in patients with a stoma.
Study Overview
Detailed Description
There are commercially available products that health insurance does not pay for to eliminate the odor caused by gas and stool output in patients with colostomy.
The limited variety of these products in our country makes it difficult for patients to access the product.
In addition, it was seen in the patient feedback that they thought these products had chemical content and were worried that they would damage the colostomy.
For these reasons, there was a need to search for more accessible, affordable, and non-chemical products.
Essential oils are volatile, aromatic, concentrated oily liquids taken from the essence of various plant parts.
Research results on the antibacterial, antifungal, antiviral, antioxidative, and antimutagenic effects of plant essential oils are generally positive.
Lavender essential oil and peppermint essential oil have been used in the past, for reasons such as creating a pleasant smell, providing wound healing, antibacterial and anxiolytic properties, and improving the quality of life.
For this reason, it is accepted that the use of herbal essential oil and extract can be one effective solution.
In the study of Kazemi et al. (2021); Lavender essential oil has also been found to be effective in wound healing.
In Duluklu's (2018) study on patients with colostomy, it was determined that there was a significant improvement in the living conditions of the experimental group formed by dripping lavender oil into the colostomy bag.
It was observed that there was a significant difference between the stoma compliance scale acceptance sub-dimension and the overall stoma compliance mean score.
In rainbow trout, Metin et al. (2015), in his study; They found that the use of peppermint oil did not cause any toxic effects on fish.
Anderson et al.) in a randomized double-blind study with individuals experiencing postoperative nausea and vomiting, given lisinopril alcohol, peppermint oil, and placebo (saline) effective products, and nausea determined at the second and fifth minutes following inhalation of peppermint oil applied to gauze before the application of peppermint oil extract.
It was determined that it decreased significantly according to the feeling of nausea.
In literature reviews; There are limited studies on using lavender essential oil for odor removal in individuals with colostomy.
There is no use of peppermint essential oil.
Using lavender oil and peppermint oil in a stoma bag is a simple, natural, and low-cost method for odor removal.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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
-
-
Adana
-
Sarıçam, Adana, Turkey, 01130
- Çukurova Üniversitesi
-
-
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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a stoma
- To be compatible with essential oils
Exclusion Criteria:
- Patients with allergic reaction
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: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: GROUP 1
GROUP 1 1st GROUP LAVENDER OIL EXTRACT WILL BE APPLIED TO 20 PATIENTS WITH COLOSTOMY FOR 1 MONTH WITH 20 DROPS A DAY INTO THE STOMA BAG |
IT WILL BE APPLIED TO 60 PATIENTS, 20 IN EACH GROUP, WITH A COLOSTOMY
Other Names:
|
|
EXPERIMENTAL: GROUP 2
2nd GROUP MINT OIL EXTRACT WILL BE APPLIED TO 20 PATIENTS WITH COLOSTOMY DURING 1 MONTH.
|
IT WILL BE APPLIED TO 60 PATIENTS, 20 IN EACH GROUP, WITH A COLOSTOMY
Other Names:
|
|
NO_INTERVENTION: CONTROL GROUP
20 PATIENTS WITH COLOSTOMY WITH NO INTERVENTION
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Effect of Different Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals with Colostomy
Time Frame: 1 month
|
İn patients with a permanent stoma; The level of discomfort from odor was measured by a questionnaire study using a numerical rating scale.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: dudu alptekin, Cukurova University
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)
April 22, 2020
Primary Completion (ACTUAL)
June 25, 2022
Study Completion (ACTUAL)
June 25, 2022
Study Registration Dates
First Submitted
July 19, 2022
First Submitted That Met QC Criteria
January 27, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
January 27, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- rid27463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
BETWEEN 2020 - 2022
IPD Sharing Time Frame
2020-2022
IPD Sharing Access Criteria
FROM THE PATIENTS APPLYING TO THE STOMATHERAPY UNIT PATIENTS MEETING THE WORKING CRITERIA
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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