Protocol summary
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Study aim
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1. Effect of Citrous Aurantium aroma on anxiety and hemodynamic parameters of patients with acute coronary syndrome.
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Design
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In this study, the target population is the patients with acute coronary syndrome admitted to Alameh Behnol Hospital in Gonabad. Sampling method is also simple random,
The sample size is 80 patients. This is a phase 2-3 clinical trial.
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Settings and conduct
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The location of this intervention is Allameh Bohlol Hospital in Gonabad.
In this one-blind study, the patient knew about the types of substances used during the intervention but did not know the type of substance to be used in each session.
In the intervention group, three drops of 10% orange spring extract were poured onto the absorbent cloth attached to the patient's collar and we wanted to inhale it for 20 minutes.
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Participants/Inclusion and exclusion criteria
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Confirmation of acute coronary syndrome by cardiologist, having reading and writing skills, mental health, company satisfaction with research, lack of history of allergy to plants, lack of olfactory problems
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Intervention groups
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The intervention and control group includes both patients who have been diagnosed with acute coronary syndrome by the cardiologist.
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Main outcome variables
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Stress; anxiety
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:
IRCT20171219037966N1
Registration date:
2018-03-19, 1396/12/28
Registration timing:
registered_while_recruiting
Last update:
2018-08-11, 1397/05/20
Update count:
1
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Registration date
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2018-03-19, 1396/12/28
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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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2017-09-06, 1396/06/15
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Expected recruitment end date
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2018-04-19, 1397/01/30
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Actual recruitment start date
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2017-09-12, 1396/06/21
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Actual recruitment end date
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2018-04-19, 1397/01/30
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Trial completion date
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empty
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Scientific title
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Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
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Public title
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Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Confirmation of acute coronary syndrome by a cardiologist
having reading and writing skills
mental health
satisfaction with the presence in the research
having no history of allergy to plants
lack of olfactory problems
Exclusion criteria:
the patient's death
the occurrence of any medical problem requiring immediate medical intervention during the study
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Age
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From 18 years old to 65 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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- Investigator
- Data analyser
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Use the method of permuted block randomization
Using binary blocks A and B
Which is by referring to the random numbers table
If the number was odd, then the AB pattern would be used if the pattern of BA was even.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Due to the intervention and recording of the results, the researcher assisted the blind researcher. The data analyzer was also blinded by ignorance of groupings
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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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2017-04-10, 1396/01/21
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Ethics committee reference number
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IR.GMU.REC.1396.17
Health conditions studied
1
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Description of health condition studied
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Acute coronary syndrome
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ICD-10 code
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I20-I25
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ICD-10 code description
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Ischaemic heart diseases
Primary outcomes
1
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Description
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state Anxiety
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Timepoint
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Before the intervention and the first day after the intervention and the second day after the intervention
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Method of measurement
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Spielberger Anxiety questionnaire
2
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Description
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Adjectival anxiety
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Timepoint
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Before the intervention and the first day after the intervention and the second day after the intervention
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Method of measurement
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Spielberger Anxiety questionnaire
3
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Description
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stress
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Timepoint
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Before the intervention and the first day after the intervention and the second day after the intervention
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Method of measurement
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PSS-4 cohen stress questionnaire
4
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Description
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blood pressure
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Timepoint
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Before, five, thirty-sixty minutes after the intervention
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Method of measurement
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Digital SADAT Blood Pressure Measurement Device
5
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Description
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pulse oximetery
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Timepoint
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Before, five, thirty-sixty minutes after the intervention
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Method of measurement
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Monitoring device
6
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Description
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temperature
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Timepoint
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Before, five, thirty-sixty minutes after the intervention
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Method of measurement
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Welch Allyn tympanic thermometer
Intervention groups
1
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Description
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In the intervention group, the patients inhaled three drops of 10% essential oil on an absorbent cloth attached to the patient's collar for 20 minutes.
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Category
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Treatment - Drugs
2
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Description
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Control group: In the placebo group, patients inhaled three drops of distilled water on the absorbent tissue cloth attached to their collars.
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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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Gonabad 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available