This is a single blind clinical trial to evaluate the effect of peppermint aroma on nausea and vomiting of patients with acute myocardial infarction in Arak Amirkabir Hospital. One hundred twenty six patients with acute myocardial infarction will be selected according to inclusion and exclusion criteria and will be divided into two groups randomly (Peppermint and placebo).Peppermint scented pads will be prepared by placing 0.2 mL of essential oil of peppermint on a 2*2 inch gauze pads; placebo pads will be prepared by placing 0.2 mL of isotonic saline. These pads will be attached to the patients’ clothes for 24 hours. The severity of nausea will be evaluated by visual analog scale and vomiting by counting vomiting times during 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112415507N1
Registration date:2014-05-21, 1393/02/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-21, 1393/02/31
Registrant information
Name
Maryam Mohsenifard
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 6449
Email address
m.mohseni@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-07-11, 1393/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Peppermint essence on nausea and vomiting in patients with acute myocardial infarction
Public title
The effect of Peppermint Aroma on Nausea and Vomiting in Patients with Acute Myocardial Infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:30-88 years old, diagnosis of acute myocardial infarction according to clinical signs, electrocardiography and cardiac biomarkers that confirmed by the cardiologist.
Exclusion criteria: cardiogenic shock, acute asthma, chronic obstructive pulmonary disease, congestive heart failure class III or IV, cardiopulmonary resuscitation, recurrent myocardial infarction, and allergy to peppermint compounds.
Age
From 30 years old to 88 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is Simple
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran
City
Arak
Postal code
Approval date
2013-04-22, 1392/02/02
Ethics committee reference number
92-144-10
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
I21.0,I21.1,I21.2,I21.3,I21.4,I21.9
Primary outcomes
1
Description
Nausea
Timepoint
0-2-4-6-8-10-16-24
Method of measurement
Visual Analog Scale for Nausea
2
Description
Vomiting
Timepoint
0-2-4-6-8-10-16-24
Method of measurement
Check List
Secondary outcomes
1
Description
Pulse Rate
Timepoint
0-2-4-6-8-12-16-18-24
Method of measurement
Pulse Counting
2
Description
Respiratory Rate
Timepoint
0-2-4-6-8-12-16-18-24
Method of measurement
Respiratory Rate Counting
3
Description
Blood Pressure
Timepoint
0-2-4-6-8-12-16-18-24
Method of measurement
Millimeters of Mercury, Using Manometer and Blood Pressure Cuff
4
Description
Temperature
Timepoint
0-2-4-6-8-12-16-18-24
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group: Peppermint scented gauze pads will be prepared by placing 0.2 mL of essential oil of peppermint. These pads will be attached to the patients’ clothes for 24 hours.
Category
Treatment - Other
2
Description
Control group: placebo pads will be prepared by 0.2 mL of isotonic saline. These pads will be attached to the patients’ clothes for 24 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr. Alireza Alisaeedi, Cardiologist
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Arak University of Medical Sciences
Full name of responsible person
Saeed Babaie
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Mohsenifard
Position
Bsc in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3368 6449
Fax
Email
m.mohseni@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
Msc in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
k.rezaei@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Mohsenifard
Position
Bsc in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran .
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)