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The effect of orange blossom aroma therapy on physiological parameters and anxiety in patients with coronary artery diseased admitted for angiography In2017

Protocol summary

Summary
Diagnostic coronary angiography, is an invasive cardiovascular diagnosis of coronary artery disease. The aim of this study was to determine the effect of sour orange aromatherapy on physiological indexes and stress in Cardiac patients admitted to coronary angiography. Inclusion criteria: patient willingness to participate in the study; Smell test positive, patients who are undergoing coronary angiography for the first time; patients who are not taken nitrate and housing from 6 hours ago, do not have allergies and determine which factors like hospitalization and treatment for mental health problems. Exclusion criteria: history of drug addiction; the disorders of smell and patients who underwent an emergency are angiogenesis. This study would be a randomized clinical trial of the two groups in 2017, Research community will be patients Hospitalized in cardiac angiography Heshmat Hospital in Rasht, with a sample size of 36 participants in each group. All three forms to collect demographic, physiological, standard anxiety questionnaire "Speal Berger" will be used. First, using a standard anxiety questionnaire " Speal burger", patients is known with high levels of anxiety (over 43), then Will be in the group with aromatherapy or without it by simple random sampling. To compare the two groups, including the pre-test, analysis of variance will be used and to examine the relationship between qualitative variables, Chi-square test will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051133808N1
Registration date: 2017-06-14, 1396/03/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Parand Pourghane
Name of organization / entity
Guilan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 0149
Email address
p.pourghane@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university Of Medical Sciences, Rasht, Iran
Expected recruitment start date
2017-06-01, 1396/03/11
Expected recruitment end date
2018-06-01, 1397/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of orange blossom aroma therapy on physiological parameters and anxiety in patients with coronary artery diseased admitted for angiography In2017
Public title
The effect of aroma therapy on physiological parameters and anxiety in patients with coronary artery diseased
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The willingness of the patient to participate in the study; patients first underwent coronary angiography placed before angiography; under other methods of invasive Transesophageal echocardiography; not be 6 hours ago nitrate and housing consumption; are not allergies; rhinitis allergic; eczema and respiratory problems have not; before the intervention, no history of headache; perfume or cologne before or during treatment; not experience stress event acute over the past 6 months; and no history of hospitalization and treatment; not because of psychological problems. Also, testing positive smell (the ability to detect the smell of aromatherapy desired solution and Pleasure it is the other inclusion criteria. Exclusion criteria: having a history of drug addiction According expressed by the patient; as well as having disorders; colds and nasal congestion that affect the sense of smell; the study exclusion criteria will be considered. Also, patients who underwent an emergency angiography are enrolled STEMI patients do not like.
Age
From 19 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan university Of Medical Sciences
Street address
Gas field, martyr Beheshti Blvd, in front of the West Bank Sepah , on behalf of Radiator Vice Chancellor for Research and Technology, Guilan, Rasht, Iran
City
Rasht
Postal code
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.GUMS.REC.1395/348

Health conditions studied

1

Description of health condition studied
Patients with Coronary Artery Disease
ICD-10 code
I24.0
ICD-10 code description
Coronary thrombosis not resulting in myocardial infarction

Primary outcomes

1

Description
Anxiety
Timepoint
Half an hour before - Half an hour later
Method of measurement
The State-Trait Anxiety Inventory

2

Description
Physiological parameters
Timepoint
Half an hour before and half an hour later
Method of measurement
blood pressure with Sphygmomanometer, Pulse counting with touch of the radial artery, , respiration rate based looking at the numbers going up and down the chest, temperature control based with thermometer

Secondary outcomes

empty

Intervention groups

1

Description
For the control group, does not the intervention
Category
N/A

2

Description
For the control group, does not the intervention
Category
N/A

3

Description
First, using a standard anxiety questionnaire "Steel standard questionnaire Burger", patients with high levels of anxiety (over 43) will be recognized. Then, these people Will be with simple random sampling in the group will be aromatherapy or without it. During aromatherapy for patients, Researchers will try to accuracy in conducting research on aromatherapy aimed lack of awareness of other patients in the group Without aromatherapy. Essential oil used licensed by Ministry of Health with code: 16210/34 Series also includes the construction of 5027 and its compounds: linalool, linalyl acetate, propylene glycol, Jranyvl, oil and phenyl ethyl alcohol Petit Green. Before leaving for angiography, completed demographic questionnaires and measured their anxiety. That 3 drops of essential oil of Citrus aurantium using the dropper on the balls of cotton in a container volume of 10 mL spinner and recommended distance of 5 cm nose, hold for 3 minutes and sniffed the half hours after vital signs monitor and recorded by a nurse and then will be transferred to the angiography room.
Category
Prevention

4

Description
First, using a standard anxiety questionnaire "made burger", patients with high levels of anxiety (over 43) will be recognized. Then, these people, simple random sampling in the group will be aromatherapy or without it. Essential oil used licensed by Ministry of Health with code: 16210/34 Series also includes the construction of 5027 and its compounds: linalool, linalyl acetate, propylene glycol, Jranyvl, oil and phenyl ethyl alcohol Petit Green. Before leaving for angiography, completed demographic questionnaires and measured their anxiety. That 3 drops of essential oil of Citrus aurantium using the dropper on the balls of cotton in a container volume of 10 mL spinner and recommended distance of 5 cm nose, hold for 3 minutes and sniffed the half hours after vital signs monitor and recorded by a nurse and then will be transferred to the angiography room.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Angiography Heart Hospital glory, Guilan, Rasht
Full name of responsible person
Parand Pourghane
Street address
Gas field in front of Radiator Vice, Chancellor for Research and Technology, Guilan, Rasht
City
rasht

2

Recruitment center
Name of recruitment center
Heart Hospital glory, Guilan, Rasht
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan university Of Medical Sciences
Full name of responsible person
Fatemeh Zaer Sabet
Street address
Street Namgoo, University of Education Of Medical Sciences, , Guilan, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan university Of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Fatemeh Zaer Sabet
Street address
University of Education of Medical Sciences, Street Namgoo, Guilan, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan university of Medical Sciences
Proportion provided by this source
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
Guilan university Of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
Assistant Professor, phD
Other areas of specialty/work
Street address
Gas field in front of Radiator Vice, Chancellor for Research and Technology, Rasht
City
Rasht
Postal code
Phone
+98 13 3336 2772
Fax
Email
p.pourghane@yahoo.comp.pourghane@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan university Of Medical Sciences, Rasht, Iran
Full name of responsible person
Parand Pourghane
Position
Assistant Professor, phD
Other areas of specialty/work
Street address
Research Council, Guilan, Rasht
City
Rasht
Postal code
Phone
+98 13 3336 2772
Fax
Email
p.pourghane@yahoo.comp.pourghane@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Parand Pourghane
Position
Assistant Professor, phD
Other areas of specialty/work
Street address
Research Council, Guilan, Rasht
City
rasht
Postal code
Phone
00
Fax
Email
p.pourghane@yahoo.comp.pourghane@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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