The object of study is determining the effect of peppermint essence inhalation on the reduction of nausea and vomiting in patients after open heart surgery
Design
This study is a randomized clinical trial, with double blind parallel group with sample size of 60 at least 30 per groups. The first phase of intervention will be made when patients have criteria of extubation. The second time of intervention will be made 4 hours after extubation by using of a nebulizer mask. The third intervention is after eight hours of extubation. The control group also received normal saline in the same three time .
Settings and conduct
This study will be carried out in the ward of the heart surgery of Kashan Shahid Beheshti Hospital. Peppermint essential to patients in the intervention group will be take after open heart surgery. Severity of nausea and vomiting of patients will be investigated after three times in the intervention and control groups. Blinding will be made for patients participating and analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lack of any sensitivity to peppermint compounds, breathing problem, the lack of auditory and cognitive problems in order to answer questions of the questionnaire, elective surgery, Not taking nausea and vomiting drugs prior to surgery. Excluded criteria: Lack of cooperation to continue during the study, incidence of any sensitivity to peppermint, intolerance of peppermint essence smell, the patient's death, prescription of nausea and vomiting drugs
Intervention groups
Patients in the intervention group receive peppermint essence inhalation in 3 times, and patients in the control group in 3 times receive the normalsalin as placebo.
Main outcome variables
nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100124003146N5
Registration date:2019-02-10, 1397/11/21
Registration timing:registered_while_recruiting
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Ismail Azizi-Fini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
azizi-es@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peppermint essence inhalation on reduce the severity of nausea and vomiting in patients after open heart surgery
Public title
The effect of peppermint essence inhalation on reduce the severity of nausea and vomiting in patients after open heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with open heart surgery above 18 years old
Extubation after 12 hours of surgery
Awareness after Extubation
Exclusion criteria:
All patients with open heart surgery above 18 years old
Extubation after 12 hours of surgery
Awareness after Extubation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of each day, in order to prevent the revelation of the intervention and essence odor, it will be determined by the throwing of the coin and then randomly assigned to which of the intervention or control groups on the same day. Then patients who undergo surgery according to the routine are randomly assigned in the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study because the essential ingredient in the ward may be emitted, the cases of groups will be taken from each other in different days. Consequently, the samples in different groups will not be aware of the type of intervention. Also analyzer will not be aware on the type of intervention in groups.
Placebo
Used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-12-08, 1397/09/17
Ethics committee reference number
Ir.Kaums.Nuhepm.Rec.1397.046
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea
Timepoint
Before of extubation, 4 hour after of extubation, 8 hour after of extubation
Method of measurement
Questionnaire
2
Description
Vomiting
Timepoint
Before of extubation, 4 hour after of extubation, 8 hour after of extubation
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group receive peppermint essence inhalation in 3 times
Category
Treatment - Other
2
Description
Patients in the control group in 3 times receive the normal salin as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital of Kashan
Full name of responsible person
Mahla Maghami
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mahlamaghami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Esmail Azizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0022
Email
azizi_es@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Esmail Azizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0022
Email
azizi_es@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahla Maghami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravand Ave., Parastar Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+55 540021
Fax
Email
mahlamaghami@yahoo.com
Web page address
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