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General information
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Effect of citrous Aurantium aroma on anxiety of acute coronary syndrome patients
Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
تاثیر رایحه درمانی با بهار نارنج بر اضطراب بیماران سندرم کرونری حاد
تاثیر رایحه درمانی با بهار نارنج بر اضطراب، استرس و شاخص های همودینامیک بیماران سندرم کرونری حاد
تاثیر رایحه درمانی با بهار نارنج بر اضطراب، استرس و شاخص های همودینامیک بیماران سندرم کرونری حاد
Effect of citrous Aurantium aroma on anxiety of acute coronary syndrome patients
Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
تاثیر رایحه درمانی استنشاقی با بهار نارنج بر اضطراب بیماران سندرم کرونری حاد: كارآزمايي باليني تصادفي شده يك سو کور در دو گروه (مداخله و پلاسبو)
تاثیر رایحه درمانی استنشاقی با بهار نارنج بر اضطراب، استرس و شاخص های همودینامیک بیماران سندرم کرونری حاد: كارآزمايي باليني تصادفي شده يك سو کور در دو گروه (مداخله و پلاسبو)
تاثیر رایحه درمانی استنشاقی با بهار نارنج بر اضطراب، استرس و شاخص های همودینامیک بیماران سندرم کرونری حاد: كارآزمايي باليني تصادفي شده يك سو کور در دو گروه (مداخله و پلاسبو)
Due to the use of distilled water, they could not distinguish between them in containers of the same appearance
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
Due to the use of distilled water, they could not distinguish between them in containersintervention and recording of the same appearanceresults, the researcher assisted the blind researcher. The data analyzer was also blinded by ignorance of groupings
بدلیل استفاده از آب مقطر در ظروف با ظاهر مشابه بیمار قادر به تشخیص انها از یکدیگر نبود
بدلیل انجام مداخله و ثبت نتایج توسط دستیار پژوهشگر، محقق کور شد. آنالیزکننده داده ها نیز بذلیل عدم اطلاع از گروه بندی ها کور شد.
بدلیل استفادهانجام مداخله و ثبت نتایج توسط دستیار پژوهشگر، محقق کور شد. آنالیزکننده داده ها نیز بذلیل عدم اطلاع از آب مقطر در ظروف با ظاهر مشابه بیمار قادر به تشخیص انها از یکدیگر نبودگروه بندی ها کور شد.
Primary outcomes
#1
empty
blood pressure
blood pressure
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فشار خون
فشار خون
empty
Before, five, thirty-sixty minutes after the intervention
Before, five, thirty-sixty minutes after the intervention
empty
قبل، پنج، سی و شصت دقیقه بعد از مداخله
قبل، پنج، سی و شصت دقیقه بعد از مداخله
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Digital SADAT Blood Pressure Measurement Device
Digital SADAT Blood Pressure Measurement Device
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دستگاه دیجیتال اندازه گیری فشار خون SADAT
دستگاه دیجیتال اندازه گیری فشار خون SADAT
#2
empty
pulse oximetery
pulse oximetery
empty
پالس اکسیمتری
پالس اکسیمتری
empty
Before, five, thirty-sixty minutes after the intervention
Before, five, thirty-sixty minutes after the intervention
empty
قبل، پنج، سی و شصت دقیقه بعد از مداخله
قبل، پنج، سی و شصت دقیقه بعد از مداخله
empty
Monitoring device
Monitoring device
empty
دستگاه مانیتورینگ
دستگاه مانیتورینگ
#3
empty
temperature
temperature
empty
دما
دما
empty
Before, five, thirty-sixty minutes after the intervention
Before, five, thirty-sixty minutes after the intervention
empty
قبل، پنج، سی و شصت دقیقه بعد از مداخله
قبل، پنج، سی و شصت دقیقه بعد از مداخله
empty
Welch Allyn tympanic thermometer
Welch Allyn tympanic thermometer
empty
دماسنج تمپانیک شرکت ولچ آلین
دماسنج تمپانیک شرکت ولچ آلین
Protocol summary
Study aim
1. Effect of Citrous Aurantium aroma on anxiety and hemodynamic parameters of patients with acute coronary syndrome.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
The intervention and control group includes both patients who have been diagnosed with acute coronary syndrome by the cardiologist.
Main outcome variables
Stress; anxiety
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Amirreza Nasirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
nasirzadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
2017-09-12, 1396/06/21
Actual recruitment end date
2018-04-19, 1397/01/30
Trial completion date
empty
Scientific title
Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
Public title
Effect of citrous Aurantium aroma on anxiety, stress and hemodynamic indices of acute coronary syndrome patients
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Iran, Gonabad, Asian Roads, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2017-04-10, 1396/01/21
Ethics committee reference number
IR.GMU.REC.1396.17
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
state Anxiety
Timepoint
Before the intervention and the first day after the intervention and the second day after the intervention
Method of measurement
Spielberger Anxiety questionnaire
2
Description
Adjectival anxiety
Timepoint
Before the intervention and the first day after the intervention and the second day after the intervention
Method of measurement
Spielberger Anxiety questionnaire
3
Description
stress
Timepoint
Before the intervention and the first day after the intervention and the second day after the intervention
Method of measurement
PSS-4 cohen stress questionnaire
4
Description
blood pressure
Timepoint
Before, five, thirty-sixty minutes after the intervention
Method of measurement
Digital SADAT Blood Pressure Measurement Device
5
Description
pulse oximetery
Timepoint
Before, five, thirty-sixty minutes after the intervention
Method of measurement
Monitoring device
6
Description
temperature
Timepoint
Before, five, thirty-sixty minutes after the intervention
Method of measurement
Welch Allyn tympanic thermometer
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: In the placebo group, patients inhaled three drops of distilled water on the absorbent tissue cloth attached to their collars.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational Center, Allameh Bhlol Gonabadi Medical Research Center
Full name of responsible person
Hamid Dehqan Haqiqi
Street address
Vahdat Street
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Nasirzadeharnz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Sajjadi
Street address
Iran, Gonabad, Asian Roads, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
moallef@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
ُStudent
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Iran, Gonabad, Asian Roads, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeh@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mehdi Basiri Moghaddam
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad
City
Iran, Gonabad, Asian Roads, Gonabad University of Medical Sciences
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
basiri1344@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Iran, Gonabad, Asian Roads, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeharnz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available