Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
Primary Purpose
Inhalation; Oil
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peppermint Oil Inhalation
Sponsored by
About this trial
This is an interventional supportive care trial for Inhalation; Oil focused on measuring patient, nausea, Vomiting, mentha piperita, postoperative
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Peppermint oil will be applied by diluting 1/10 in wheat oil so that it does not cause skin irritation.
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.
Outcomes
Primary Outcome Measures
Nause
post-operative nausea rate
Secondary Outcome Measures
Full Information
NCT ID
NCT05585086
First Posted
October 15, 2022
Last Updated
October 26, 2022
Sponsor
Gümüşhane Universıty
Collaborators
Kırklareli University
1. Study Identification
Unique Protocol Identification Number
NCT05585086
Brief Title
Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
Official Title
Determination of the Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 20, 2022 (Anticipated)
Primary Completion Date
March 20, 2023 (Anticipated)
Study Completion Date
April 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gümüşhane Universıty
Collaborators
Kırklareli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation; Oil
Keywords
patient, nausea, Vomiting, mentha piperita, postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Peppermint oil will be applied by diluting 1/10 in wheat oil so that it does not cause skin irritation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Peppermint Oil Inhalation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nause
Description
post-operative nausea rate
Time Frame
7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Peppermint Oil Inhalation on Postoperative Nausea, Vomiting and Comfort
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