- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05585086
Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
• Individuals who do not meet the inclusion criteria will not be included in the
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Peppermint oil will be applied by diluting 1/10 in wheat oil so that it does not cause skin irritation.
|
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.
|
|
No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nause
Time Frame: 7 day
|
post-operative nausea rate
|
7 day
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Respiratory Aspiration
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Peppermint oil
Other Study ID Numbers
- GumushaneU2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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