StomaStoma CareNCT07195136
Orenage Blossom Oil Essential Application in Stoma
A study testing Essential Oil in people with Stoma and Nursing, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Because the stoma will become a part of the individual's body and directly impact their quality of life, careful attention should be paid to its location and surgical procedure. Stoma care nurses should provide effective training to patients and those responsible for their care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma, Nursing, Nursing Care
- What is being tested?
- Essential Oil
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2025to 1 Nov 2025
- 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
- Volunteer to participate in the study
- Over 18 years of age
- With a stoma
- No stoma-related complications
Who cannot join
- Leaving the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Orange Blossom Essential Oil Placed in the Stoma Bag on Odor Removal, Social Isolation, and Stoma Adaptation in Individuals With Stoma
Because the stoma will become a part of the individual's body and directly impact their quality of life, careful attention should be paid to its location and surgical procedure. Stoma care nurses should provide effective training to patients and those responsible for their care. Patients and their families should be regularly monitored, followed up, and cared for at home after discharge. They should also be provided with information about appropriate units to consult if any problems arise. Stoma support groups should be established to foster social interaction. A well-planned surgical procedure protects individuals from the development of complications and problems that can be considered a "life sentence."
Read the detailed description
This prospective, randomized, controlled study aims to investigate the effects of orange blossom essential oil placed in the stoma bag on odor reduction, social isolation, and stoma compliance in individuals with permanent colostomies. Sample size calculations were performed using a priori power analysis (t-test) for the intervention and control groups. Accordingly, with an effect size of d=1.12, a 5% error rate (α=0.05), and 80% power (1-β=0.80), the minimum sample size for both groups was calculated as 54. Considering potential losses, the total sample size will be increased by 10%, with 30 patients in each group (Experimental Group: 30, Control Group: 30), for a total of 60 patients. Data will be collected using a patient personal information form, a patient information form, a compliance scale for individuals with stoma, and a social isolation scale, all prepared by the researchers based on literature.
- Conditions
- Stoma, Nursing, Nursing Care, Essential Oil
- Being tested
- Essential Oil
- Keywords
- stoma, nursing, nursin care, essenntial oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential OilBehavioural
essential oil
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | essential oil Receives: Behavioral: Essential Oil |
| control | No intervention | standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma Adaptation Scale
Scale items are scored between 0 and 4. The minimum score is 0 and the maximum is 92. A higher score indicates greater compliance with the stoma.
Measured: 30 day
Social Isolation Scale
Scale items are scored on a 1-3 scale. The minimum score is 14 and the maximum is 42. As the score increases, the level of social isolation increases.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start18 Sep 2025
- Primary completion1 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using the Training Brochure, participants were instructed, lasting approximately 15 minutes, to place 10 drops of orange blossom essential oil into their clean bags during colostomy bag changes and spread the oil throughout the entire inner surface of the bag. During this training, the application was first administered by the researcher, and then performed by the patient under the researcher's supervision. The patients in the experimental group were provided with orange blossom essential oil by the researcher for use for one month.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Akbaş, Cukurova University
- Investigators
- Meltem Akbaş, Principal investigator, Universty Of Cukurova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195136
- Sponsor's protocol ID
- 06.09.2024/145
- Other IDs
- Cukurova University
- Acronym
- Stoma Care
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2025
- Last updated
- 20 Mar 2026
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Orange Blossom Essential Oil Placed in the Stoma Bag on Odor Removal, Social Isolation, and Stoma Adaptation in Individuals With Stoma
- ClinicalTrials.gov ID
- NCT07195136
- Acronym / sponsor ID
- Stoma Care / 06.09.2024/145
- Conditions
- Stoma, Nursing, Nursing Care, Essential Oil
- Keywords
- stoma, nursing, nursin care, essenntial oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 26 Sep 2025 (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.
Because the stoma will become a part of the individual's body and directly impact their quality of life, careful attention should be paid to its location and surgical procedure. Stoma care nurses should provide effective training to patients and those responsible for their care. Patients and their families should be regularly monitored, followed up, and cared for at home after discharge. They should also be provided with information about appropriate units to consult if any problems arise. Stoma support groups should be established to foster social interaction. A well-planned surgical procedure protects individuals from the development of complications and problems that can be considered a "life sentence."
Detailed description
This prospective, randomized, controlled study aims to investigate the effects of orange blossom essential oil placed in the stoma bag on odor reduction, social isolation, and stoma compliance in individuals with permanent colostomies. Sample size calculations were performed using a priori power analysis (t-test) for the intervention and control groups. Accordingly, with an effect size of d=1.12, a 5% error rate (α=0.05), and 80% power (1-β=0.80), the minimum sample size for both groups was calculated as 54. Considering potential losses, the total sample size will be increased by 10%, with 30 patients in each group (Experimental Group: 30, Control Group: 30), for a total of 60 patients. Data will be collected using a patient personal information form, a patient information form, a compliance scale for individuals with stoma, and a social isolation scale, all prepared by the researchers based on literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Using the Training Brochure, participants were instructed, lasting approximately 15 minutes, to place 10 drops of orange blossom essential oil into their clean bags during colostomy bag changes and spread the oil throughout the entire inner surface of the bag. During this training, the application was first administered by the researcher, and then performed by the patient under the researcher's supervision. The patients in the experimental group were provided with orange blossom essential oil by the researcher for use for one month.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Essential Oilessential oil |
| control | No intervention | –standart care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer to participate in the study
- Over 18 years of age
- With a stoma
- No stoma-related complications
Key exclusion criteria (1 listed)
- Leaving the study
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 |
|---|---|---|
| Essential Oilessential oil | Behavioural | intervention |
Primary outcome
Stoma Adaptation Scale
Time frame: 30 day
Scale items are scored between 0 and 4. The minimum score is 0 and the maximum is 92. A higher score indicates greater compliance with the stoma.
Social Isolation Scale
Time frame: 30 day
Scale items are scored on a 1-3 scale. The minimum score is 14 and the maximum is 42. As the score increases, the level of social isolation increases.
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 20 Mar 2026.
- 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.
Meltem Akbaş principal investigator
Universty Of Cukurova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Oil in people with Stoma and Nursing, 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 4 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 20 Mar 2026. 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?
Stoma Adaptation Scale (time frame: 30 day). 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 20 Mar 2026.