The comparison of lemon essence with placebo on anxiety, blood pressure and electrocardiogram changes in patients with acute myocardial infarction
Design
A clinical trial with control group, parallel group randomised trial with blinded outcomes
Settings and conduct
The settings of the study would be all Hematology and Oncology wards in Namazi and Amir Hospital affiliated to Shiraz University of Medical Sciences. In this study, a person who collects the outcomes of the study, as well as a statistician and health care provider, will be blind until the end of the study and completion of the data analysis and reporting.
Participants/Inclusion and exclusion criteria
The inclusion criteria were having acute myocardial infarction, being 18 years old or above, speak Persian language and oriented to time, person and place. The patients who have had an asthma, a respiratory allergy or be sensitive to extracts of the plant; who have had olfactory problems, and nasal injury; who have being known case of psychological diseases (major depression, anxiety, psychosis, etc.); who have had previous cardiovascular diseases, old myocardial infarction, and performed coronary artery bypass surgery, and Percutaneous transluminal coronary angioplasty; who have had previously arrhythmia (atrial fibrillation, ventricular atrial block, left and right heart block and ...); who have had chronic bronchitis, atelectasis, and other chronic respiratory diseases; who participated in previous studies received complementary and alternative interventions from a week before the intervention would be excluded.
Intervention groups
Take five drops of lemon essence on a cotton pad and put it in an open box at a distance of 20 centimeters of the patients. This essence is used at 8:30, 10:30, 12:30, 14:30, 16:30, 18:30 and 20:30 hours.
Main outcome variables
Anxiety, blood pressure, and electrocardiogram changes
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20130616013690N5
Registration date:2018-09-22, 1397/06/31
Registration timing:registered_while_recruiting
Last update:2018-09-22, 1397/06/31
Update count:3
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Masoume Rambod
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
rambodm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-13, 1397/05/22
Expected recruitment end date
2018-12-13, 1397/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the lemon essence with placebo on anxiety, blood pressure, and electrocardiogram changes in patients with acute myocardial infarction
Public title
Effect of the lemon essence on patients with acute myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of acute myocardial infarction according to patient records
Patients with 18 years old or above
be able to speak in Persian language
being oriented to time, person and place
Exclusion criteria:
Patient has an asthma, a respiratory allergy or be sensitive to extracts of the plant
the patient had olfactory problems, and nasal injury
being known case of psychological diseases (major depression, anxiety, psychosis, etc.)
having previous cardiovascular diseases, old myocardial infarction, and performed coronary artery bypass surgery, Percutaneous transluminal coronary angioplasty
Presence of previously recognized arrhythmia (atrial fibrillation, ventricular atrial block, left and right heart block and ...)
having chronic bronchitis, atelectasis, and other chronic respiratory diseases
Participated in previous studies received complementary and alternative interventions from a week before the intervention
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the use of lemon essence and the probability of distribution of odor in the CCU ward and its effect on the control group, the CCU wards would be divided into an intervention and control groups, randomly. In order to this, ten CCU wards (three wards in Faghihi hospital, three wards in Nemazi hospital, and four in Azahra Heart Center) would be divided into two the intervention and control groups, and based on block randomization with two wards per block, they would assigned into the intervention or control groups
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person who evaluates the outcome, the healthcare staff , and the statistician would be remained blind into the groups. For this purpose, all of the above individuals would be blind into the groups until the analysis of the data is complete and reported.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
Vice chancellor for research affairs, seven floor, Shiraz University of Medical Science, beside Helal Ahmar, Zand Ave, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.SUMS.REC.1397.412
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
121
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Anxiety
Timepoint
30 minutes before the intervention and four days after the intervention at 8:00 A.M.
Method of measurement
Spielberger State-Trait Anxiety Inventory (STAI)
Secondary outcomes
1
Description
Blood pressure
Timepoint
30 minutes before the intervention and every day from second to fourth days at 8 A.M.
Method of measurement
Digital heart monitoring device
2
Description
Electrocardiogram changes
Timepoint
30 minutes before the intervention and every day from second to fourth days at 8 A.M.
Method of measurement
Digital heart monitoring device
Intervention groups
1
Description
Intervention group: Take five drops of lemon essence on a cotton pad and put it in an open box at a distance of 20 centimeters of the patients. This essence is used at 8:30, 10:30, 12:30, 14:30, 16:30, 18:30 and 20:30 hours. Lemon essence would receive from Ahura-Daro Shiraz company with its certificate.
Category
Prevention
2
Description
Control group: Five drops of liquid paraffin are put on cotton at a distance of 20 cm from the patient's head, and this paraffin is used at 8:30, 10:30, 12:30, 14:30, 16:30, 18:30 and 20: 30.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi and Namazi hospital and Alzahra Heart Center
Full name of responsible person
Masoume Rambod
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Vice chancellor for research affairs of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3647 4258
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistante Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Assistante Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery University, Namazee Sq, Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4258
Email
rambodma@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Main outcomes
When the data will become available and for how long
2018-19
To whom data/document is available
University institutes
Under which criteria data/document could be used
The data can only be accessed by the journal that want to publish the article and no further use is permitted.
From where data/document is obtainable
In order to access to the data, contact to Email: rambodma@yahoo.com
What processes are involved for a request to access data/document
In order to access to the data, contact to Email: rambodma@yahoo.com