Protocol summary
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Study aim
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The comparison of lemon essence with placebo on anxiety, blood pressure and electrocardiogram changes in patients with acute myocardial infarction
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Design
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A clinical trial with control group, parallel group randomised trial with blinded outcomes
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Settings and conduct
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The settings of the study would be CCU wards in Faghihi, and Namazi hospital and AlZahra Heart Center 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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Anxiety, blood pressure, and electrocardiogram changes
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130616013690N5
Registration date:
2018-09-22, 1397/06/31
Registration timing:
prospective
Last update:
2019-09-15, 1398/06/24
Update count:
3
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Registration date
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2018-09-22, 1397/06/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-23, 1397/07/01
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Expected recruitment end date
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2018-12-13, 1397/09/22
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the lemon essence with placebo on anxiety, blood pressure, and electrocardiogram changes in patients with acute myocardial infarction
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Public title
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Effect of the lemon essence on patients with acute myocardial infarction
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 AlZahra 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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-29, 1397/05/07
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Ethics committee reference number
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IR.SUMS.REC.1397.412
Health conditions studied
1
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Description of health condition studied
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Acute myocardial infarction
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ICD-10 code
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121
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ICD-10 code description
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ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
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Description
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Anxiety
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Timepoint
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30 minutes before the intervention and four days after the intervention at 8:00 A.M.
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Method of measurement
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Spielberger State-Trait Anxiety Inventory (STAI)
Secondary outcomes
1
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Description
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Blood pressure
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Timepoint
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30 minutes before the intervention and every day from second to fourth days at 8 A.M.
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Method of measurement
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Digital heart monitoring device
2
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Description
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Electrocardiogram changes
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Timepoint
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30 minutes before the intervention and every day from second to fourth days at 8 A.M.
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Method of measurement
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Digital heart monitoring device
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Main outcomes
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When the data will become available and for how long
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2018-19
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To whom data/document is available
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University institutes
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Under which criteria data/document could be used
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The data can only be accessed by the journal that want to publish the article and no further use is permitted.
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From where data/document is obtainable
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In order to access to the data, contact to Email: rambodma@yahoo.com
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What processes are involved for a request to access data/document
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In order to access to the data, contact to Email: rambodma@yahoo.com
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Comments
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