This is a single blind clinical trial that pradict the impact of inhaled peppermint oil on the stress myocardial infarction patients in Cardiac intensive care unit that is done in Sirjan hospitals. Seventy patients diagnosed with myocardial infarction due to the inclusion criteria(confirmed the diagnosis of myocardial infarction according to diagnos of physician) and exclusion criteria(having cardiac dysrhythmia) for this purpose.and will be selceted randomly and placed in two groups (mint and placebo).for preparing the mint scented pads 0.2 mL of peppermint oil placed on the 2*2 inch gauze pads; the placebo pads inthe same way will be prepared with 2 mL of normal saline. The pads attached tothe patient clothing for 20 minutes during 5 days . the Stress and anxiety of the patients with be measured bydass21questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121325500N1
Registration date:2016-02-08, 1394/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-08, 1394/11/19
Registrant information
Name
Aliakbar Vaezi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 9706
Email address
vaeziali@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of inhaled peppermint Essential oil on stress myocardial infarction patients Cardiac intensive care unit
Public title
Effect of inhaled peppermint Essential oil on stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 -80 years;confirmed the diagnosis of myocardial infarction according to diagnos of physician;Catching heart attack for the first time; not having asthma history ; not having allergic to smell of mint. Exclusion criteria:not having Cardiopulmonary resuscitation during the study ;using sedative drugs; benzodiazepines during the study without doctor prescription ;having heart dysrhythmia; ventricular fibrillation; cardiogenic shock; ventricular tachycardia and duringthe study
Age
From 20 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
YazdUniversity of Medical Sciences
Street address
Yazd Faculty of Nursing and Midwifery , Bu AliAlley,SafaiehStreet
City
Yazd
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
17/1/236295/پ
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
sterss
Timepoint
One day before the intervention And the last day after the intervention
Method of measurement
Dass21 questionnaire
Secondary outcomes
1
Description
Anxiety
Timepoint
One day before the intervention And the last day after the intervention
Method of measurement
Dass21 questionnaire
2
Description
sterss
Timepoint
One day before the intervention And the last day after the intervention
Method of measurement
Dass21 questionnaire
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 20minutes during the 5 days.
Category
Treatment - Other
2
Description
Control group: placebo pads will be prepared by 2 mL of normal saline. These pads will be attached to the patients’ clothes for 20 minutes during the 5 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
GharaziHospital
Full name of responsible person
Sakine Parizi
Street address
GharaziHospital Sirjan
City
Sirjan
2
Recruitment center
Name of recruitment center
Emamrezahospital
Full name of responsible person
Sakine Parizi
Street address
Street Ibn Sina,Emamrezahospital
City
Sirjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for researchYazd University of Medical Sciences
Full name of responsible person
AliAkbareVaezi
Street address
Yazd Faculty of Nursing and Midwifery , Bu AliAlley,SafaiehStreet
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for researchYazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sakine Parizi
Position
MA in Critical Care
Other areas of specialty/work
Street address
Yazd Faculty of Nursing and Midwifery , Bu AliAlley,SafaiehStreet
City
Yazd
Postal code
Phone
00
Fax
Email
sparizi66@gmail .com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Doctor Ali AkbarVaezi
Position
Doctor
Other areas of specialty/work
Street address
Yazd Faculty of Nursing and Midwifery , Bu AliAlley,SafaiehStreet
City
Yazd
Postal code
Phone
00
Fax
Email
vaeziali @ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
SakineParizi
Position
MA in Critical Care
Other areas of specialty/work
Street address
Yazd Faculty of Nursing and Midwifery ,SafaiehStreet
City
Postal code
Phone
00
Fax
Email
sparizi66@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)