Investigating The effect of peppermint oil on nausea, vomiting and post-operative pain in patients undergoing Rhinoplasty surgery: A Randomized Controlled Trial
Investigating the effect of peppermint essential oil on nausea, vomiting and postoperative pain in patients undergoing rhinoplasty at the Amirul Mominin Research and Training Center in Rasht.
Design
64 eligible patients are continuously selected. Online software (https://www.randomizer.org/) will be used for random allocation of samples in two groups. Sample size required to investigate the effect of mint essential oil on nausea, vomiting and pain in patients undergoing rhinoplasty surgery based on the results. The study of Maggi et al. with the nausea severity score equal to 4.61 ± 2.85 and 2.43 ± 2.84 in the control and intervention groups, respectively, in the first 4 hours after the operation, considering the test power of 80% and error The first type of 5% based on the following relationship, the number of 28 people in each group and taking into account 10% attrition, the volume of samples in each group equal to 32 qualified people was continuously determined.
Settings and conduct
Demographic information questionnaire is used to collect data and to investigate vomiting through observation and evaluation of nausea according to nursing reports and patients' statements, as well as VAS scale for pain. This study is carried out in Amir al-Mominin Teaching Hospital.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1- Being at least 18 years old and at most 65 years old; not having a smell problem 3-under elective rhinoplasty and septorhinoplasty surgery; 4- Not having an allergy to mint; 5- No smoking and drug use; 6- Patients in class (ASA (I, II); 7- Not breastfeeding; Exclusion criteria 1- Failure to comply with the desired anesthesia protocol; 2- Receiving anti-nausea medication before or during anesthesia; 3- Unwillingness to cooperate
Intervention groups
Peppermint essential oil
Main outcome variables
Nausea and vomiting and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210927052608N2
Registration date:2023-04-28, 1402/02/08
Registration timing:prospective
Last update:2023-04-28, 1402/02/08
Update count:0
Registration date
2023-04-28, 1402/02/08
Registrant information
Name
reza pourmohammad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4366 4045
Email address
r_pourmohammad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-27, 1402/03/06
Expected recruitment end date
2023-08-28, 1402/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The effect of peppermint oil on nausea, vomiting and post-operative pain in patients undergoing Rhinoplasty surgery: A Randomized Controlled Trial
Public title
Investigating The effect of peppermint oil on nausea, vomiting and post-operative pain in patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 18 years old and at most 65 years old
under elective rhinoplasty and septorhinoplasty surgery
Not allergic to mint
No smoking and drugs
Patients should be in ASA class (I, II).
Not breastfeeding
Exclusion criteria:
Failure to comply with the desired anesthesia protocol
Receiving anti-nausea medication before or during anesthesia
Reluctance to cooperate
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
random allocationThe number of 64 eligible patients will be continuously selected and after obtaining written consent, they will be randomly divided into two intervention and control groups. Online software (https://www.randomizer.org/) will be used for random allocation of samples in two groups. In this method, the number of 64 closed envelopes with a number from 1 to 64 written inside each envelope will be placed in front of the patient and based on the number inside the envelope and the list of numbers obtained by the software, the patient will be placed in one of two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gilan University of Medical Sciences
Street address
Gilan-Masal-Sharek town-Azadegan 1-Plaque 25
City
rasht
Province
Guilan
Postal code
4381757399
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.GUMS.REC.1402.033
Health conditions studied
1
Description of health condition studied
patients undergoing Rhinoplasty surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea
Timepoint
Recovery, ward, one hour after entering the ward
Method of measurement
Questionnaire of demographic information and to check vomiting through observation and evaluation of nausea based on nursing reports and patients' statements and also VAS scale for pain is used.
2
Description
Recovery, ward, one hour after entering the ward
Timepoint
Recovery, ward, one hour after entering the ward
Method of measurement
Questionnaire of demographic information and to check vomiting through observation and evaluation of nausea based on nursing reports and patients' statements and also VAS scale for pain is used.
Secondary outcomes
1
Description
pain
Timepoint
Recovery, ward, one hour after entering the ward
Method of measurement
VAS scale for pain.
Intervention groups
1
Description
Intervention group: Peppermint essential oil... patients in the case group are prescribed 20 oral drops (2% peppermint essence) made by Alice company half an hour before surgery
Category
Prevention
2
Description
Control group: Distilled water. The control group uses 20 drops of distilled water, which is similar in color to the original drug, so that the blinding process is carried out as much as possible.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Mo'menin Educational Remedial & Research Center
Full name of responsible person
Arman Parvizi
Street address
Behind the courthouse, 17 Shahrivar Ave,Rasht Town
City
Rasht
Province
Guilan
Postal code
4381757399
Phone
+98 13 4366 4045
Email
r_pourmohammad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
In front of 17 Shahrivar Hospital,Namjo Ave,Shahid Siyadati Ave,Rash Town
City
Rasht
Province
Guilan
Postal code
4381757399
Phone
+98 13 3333 5821
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Reza Pourmohammad
Position
MCS Surgical Technology
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.25,Azadegan1,Shahrak-e Vali Asr,Masal Town
City
Masal
Province
Guilan
Postal code
4381757399
Phone
+98 13 4366 4045
Email
r_pourmohammad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arman Parvisi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
17 Shahrivar Ave,Dr. Heshmat Square,Rasht Town
City
Rasht
Province
Guilan
Postal code
41396 38459
Phone
+98 13 3323 8306
Email
arman.parvizii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Reza Pourmohammad
Position
MSC surgical technology
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.25,Azadegan1,Shahrak-e Vali Asr,Masal Town
City
Masal
Province
Guilan
Postal code
4381757399
Phone
+98 13 4366 4045
Email
r_pourmohammad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD