Stoma Site OdorsurgeryNCT05716711
Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals With Colostomy
A study testing LAVENDER OIL in people with Stoma Site Odor, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma Site Odor
- What is being tested?
- LAVENDER OIL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2020to 25 Jun 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a stoma
- To be compatible with essential oils
Who cannot join
- Patients with allergic reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stoma Site Odor
- Being tested
- LAVENDER OIL
- Keywords
- COLOSTOMY, ODOR, LIFE SATISFACTION, STOMA HARMONY,
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAVENDER OILOther
Also called MINT OIL, NON-INTERVENTION
IT WILL BE APPLIED TO 60 PATIENTS, 20 IN EACH GROUP, WITH A COLOSTOMY
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | 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 Receives: Other: LAVENDER OIL |
| GROUP 2 | Experimental | 2nd GROUP MINT OIL EXTRACT WILL BE APPLIED TO 20 PATIENTS WITH COLOSTOMY DURING 1 MONTH. Receives: Other: LAVENDER OIL |
| CONTROL GROUP | No intervention | 20 PATIENTS WITH COLOSTOMY WITH NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Different Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals with Colostomy
İn patients with a permanent stoma; The level of discomfort from odor was measured by a questionnaire study using a numerical rating scale.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start22 Apr 2020
- Primary completion25 Jun 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stoma Site OdorStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- GROUP 1 GROUP2 CONTROL GROUP
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dudu alptekin, Cukurova University
- Investigators
- dudu alptekin, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716711
- Sponsor's protocol ID
- rid27463
- Acronym
- surgery
- Status last verified
- Jan 2023
- First submitted
- 19 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BETWEEN 2020 - 2022
Publications
Alptekin D, Arslan S. The effect of different essential oils used in stoma bags of individuals with colostomy remooval of odor, life satisfaction and effect on stoma fit: Randomized controlled study. Explore (NY). 2024 Nov-Dec;20(6):103065. doi: 10.1016/j.explore.2024.103065. Epub 2024 Oct 9.
PubMed 39418824
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals With Colostomy
- ClinicalTrials.gov ID
- NCT05716711
- Acronym / sponsor ID
- surgery / rid27463
- Conditions
- Stoma Site Odor
- Keywords
- COLOSTOMY, ODOR, LIFE SATISFACTION, STOMA HARMONY,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 8 Feb 2023 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- GROUP 1 GROUP2 CONTROL GROUP
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Other: LAVENDER OILGROUP 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 |
| GROUP 2 | Experimental | Other: LAVENDER OIL2nd GROUP MINT OIL EXTRACT WILL BE APPLIED TO 20 PATIENTS WITH COLOSTOMY DURING 1 MONTH. |
| CONTROL GROUP | No intervention | –20 PATIENTS WITH COLOSTOMY WITH NO INTERVENTION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a stoma
- To be compatible with essential oils
Key exclusion criteria (1 listed)
- Patients with allergic reaction
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 |
|---|---|---|
| LAVENDER OILAlso: MINT OIL, NON-INTERVENTIONIT WILL BE APPLIED TO 60 PATIENTS, 20 IN EACH GROUP, WITH A COLOSTOMY | Other | GROUP 1, GROUP 2 |
Primary outcome
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.
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 8 Feb 2023.
- Derived from this study: PubMed 39418824Alptekin D, Arslan S. The effect of different essential oils used in stoma bags of individuals with colostomy remooval of odor, life satisfaction and effect on stoma fit: Randomized controlled study. Explore (NY). 2024 Nov-Dec;20(6):103065. doi: 10.1016/j.explore.2024.103065. Epub 2024 Oct 9.
- Individual participant dataSharing planned: Yes. BETWEEN 2020 - 2022
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.
dudu alptekin principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAVENDER OIL in people with Stoma Site Odor, run by Cukurova 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 2 inclusion and 1 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 8 Feb 2023. 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?
The Effect of Different Essential Oils in Stoma Bags on Deodorization, Life Satisfaction, Stoma Adaptation in Individuals with Colostomy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05716711, which also lists 1 linked publication.
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 8 Feb 2023.