Inhalation; OilNCT05585086
Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
A study testing Peppermint Oil Inhalation in people with Inhalation; Oil, run by Gümüşhane Universıty.
Trial summary
Nausea and vomitting related to drugs and anesthetic methods are among the important postoperative problems. Nausea and vomitting causing illlness feeling of patient are frequent after surgical interventions, cause increased dissatisfaction of the patient and prolonged discharge period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inhalation; Oil
- What is being tested?
- Peppermint Oil Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 20 Apr 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old, 65 years old and under,
- having colonoscopy,
- not having the risk of heart failure and cardiogenic shock (class III and IV),
- not having a history of asthma, eczema and allergies to flowers and plants,
- no peppermint oil allergy,
- no communicative / severe hearing or speech impairment,
Show all 9Show fewer
- no use of antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine and narcotic derivatives
- ASA score of 1 or 2
- Individuals willing to participate will be included in the study.
Who cannot join
- Individuals who do not meet the inclusion criteria will not be included in the
About this study
Official title: Determination of the Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
Nausea and vomitting related to drugs and anesthetic methods are among the important postoperative problems. Nausea and vomitting causing illlness feeling of patient are frequent after surgical interventions, cause increased dissatisfaction of the patient and prolonged discharge period. In this study it was aimed to evaluate the effect of peppermint oil inhalation on postoperative nausea and vomitting.
Purpose and Type of Research The randomized controlled study will be performed on patients undergoing laparoscopic cholecystectomy, which is the most commonly performed surgical procedure, in a general surgery clinic of a training and research hospital.
Read the detailed description
Nausea and vomitting related to drugs and anesthetic methods are among the important postoperative problems. Nausea and vomitting causing illlness feeling of patient are frequent after surgical interventions, cause increased dissatisfaction of the patient and prolonged discharge period. In this study it was aimed to evaluate the effect of peppermint oil inhalation on postoperative nausea and vomitting. Purpose and Type of Research The randomized controlled study will be performed on patients undergoing laparoscopic cholecystectomy, which is the most commonly performed surgical procedure, in a general surgery clinic of a training and research hospital.
Location of the research This research will be carried out in a 24-bed general surgery clinic of a 250-bed training and research hospital located in western Turkey. In the Surgery Service, nurses work in three shifts, 08:00-16:00, 16:00-24:00 and 24:00-08:00, while the responsible nurse works between 08:00-17:00. In the surgical service, there are a total of 24 patient rooms, all of which are single beds. Clinical routines in the surgery clinic include pharmacological methods and there is no use of complementary therapy methods.
Population and Sample of the Research 60 patients are planned to be included in the study. In the creation of randomization; Experiment and control group will be assigned by computer method. In this way, experimental applications will be continued until the number of patients in both groups is completed. During the trial period, patients who wish to withdraw or need to be excluded from the trial will be excluded.
Research Hypotheses H0. Peppermint oil inhalation has no effect on post-operative nausea. H1. Peppermint oil inhalation has an effect on post-operative nausea. H0. Peppermint oil inhalation has no effect on postoperative comfort. H0. Peppermint oil inhalation has an effect on postoperative comfort.
- Conditions
- Inhalation; Oil
- Being tested
- Peppermint Oil Inhalation
- Keywords
- patient, nausea, Vomiting, mentha piperita, postoperative
- Medical subject headings
- Respiratory Aspiration, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint Oil InhalationOther
Peppermint oil will be given by diluting 1/10 in wheat oil so that it does not cause skin irritation. Application; by inhalation method, 2 cc lavender essential oil + 100 cc water (2%) will be in the form of two drops for 20 minutes. Since the effectiveness of essential oils decreases over time and the desired dose cannot be applied at the same time; Peppermint oil will be applied to the individual for a total of 5 times every 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Peppermint oil will be applied by diluting 1/10 in wheat oil so that it does not cause skin irritation. Receives: Other: Peppermint Oil Inhalation |
| Control | No intervention | Patients who underwent surgery will be monitored for the severity of nausea and vomiting after surgery. Follow-ups are 0-2, 2-6, 6-12, 12-24 and 24-48 postoperatively. hours and will be recorded without any application or intervention by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nause
post-operative nausea rate
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start20 Dec 2022 (estimated)
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation; OilStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Collaborators
- Kırklareli University
- Responsible party
- Principal investigator, Nursen Kulakac, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585086
- Sponsor's protocol ID
- GumushaneU2
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
- ClinicalTrials.gov ID
- NCT05585086
- Acronym / sponsor ID
- GumushaneU2
- Conditions
- Inhalation; Oil
- Keywords
- patient, nausea, Vomiting, mentha piperita, postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Collaborators
- Kırklareli University
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 18 Oct 2022 (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.
Nausea and vomitting related to drugs and anesthetic methods are among the important postoperative problems. Nausea and vomitting causing illlness feeling of patient are frequent after surgical interventions, cause increased dissatisfaction of the patient and prolonged discharge period. In this study it was aimed to evaluate the effect of peppermint oil inhalation on postoperative nausea and vomitting.
Purpose and Type of Research The randomized controlled study will be performed on patients undergoing laparoscopic cholecystectomy, which is the most commonly performed surgical procedure, in a general surgery clinic of a training and research hospital.
Detailed description
Nausea and vomitting related to drugs and anesthetic methods are among the important postoperative problems. Nausea and vomitting causing illlness feeling of patient are frequent after surgical interventions, cause increased dissatisfaction of the patient and prolonged discharge period. In this study it was aimed to evaluate the effect of peppermint oil inhalation on postoperative nausea and vomitting. Purpose and Type of Research The randomized controlled study will be performed on patients undergoing laparoscopic cholecystectomy, which is the most commonly performed surgical procedure, in a general surgery clinic of a training and research hospital.
Location of the research This research will be carried out in a 24-bed general surgery clinic of a 250-bed training and research hospital located in western Turkey. In the Surgery Service, nurses work in three shifts, 08:00-16:00, 16:00-24:00 and 24:00-08:00, while the responsible nurse works between 08:00-17:00. In the surgical service, there are a total of 24 patient rooms, all of which are single beds. Clinical routines in the surgery clinic include pharmacological methods and there is no use of complementary therapy methods.
Population and Sample of the Research 60 patients are planned to be included in the study. In the creation of randomization; Experiment and control group will be assigned by computer method. In this way, experimental applications will be continued until the number of patients in both groups is completed. During the trial period, patients who wish to withdraw or need to be excluded from the trial will be excluded.
Research Hypotheses H0. Peppermint oil inhalation has no effect on post-operative nausea. H1. Peppermint oil inhalation has an effect on post-operative nausea. H0. Peppermint oil inhalation has no effect on postoperative comfort. H0. Peppermint oil inhalation has an effect on postoperative comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Peppermint Oil InhalationPeppermint oil will be applied by diluting 1/10 in wheat oil so that it does not cause skin irritation. |
| Control | No intervention | –Patients who underwent surgery will be monitored for the severity of nausea and vomiting after surgery. Follow-ups are 0-2, 2-6, 6-12, 12-24 and 24-48 postoperatively. hours and will be recorded without any application or intervention by the researcher. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- over 18 years old, 65 years old and under,
- having colonoscopy,
- not having the risk of heart failure and cardiogenic shock (class III and IV),
- not having a history of asthma, eczema and allergies to flowers and plants,
- no peppermint oil allergy,
Key exclusion criteria (1 listed)
- Individuals who do not meet the inclusion criteria will not be included in the
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 |
|---|---|---|
| Peppermint Oil InhalationPeppermint oil will be given by diluting 1/10 in wheat oil so that it does not cause skin irritation. Application; by inhalation method, 2 cc lavender essential oil + 100 cc water (2%) will be in the form of two drops for 20 minutes. Since the effectiveness of essential oils decreases over time and the desired dose cannot be applied at the same time; Peppermint oil will be applied to the individual for a total of 5 times every 30 minutes. | Other | Experimental |
Primary outcome
Nause
Time frame: 7 day
post-operative nausea rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint Oil Inhalation in people with Inhalation; Oil, run by Gümüşhane Universıty.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Nause (time frame: 7 day). 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 28 Oct 2022.