Protocol summary

Summary
The aim of this study is determine to ‎effect of essential oil of Citrous Aurantium on anxiety of patients who underwent coronary angiography that referred to Imam Ali Hospital of Kermanshah University of Medical Sciences in ‎‎2016.‎ In this study, 80 patients who are going to angiography for the first time will be studied. Patients will be divided in two equal case and control groups. In the case group, the questionnaire of demographic information and Spielberger anxiety are ‎completed before intervention. Then pure Citrous Aurantium oil will be ‎breathed by patients before angiography. Then the questionnaire of Spielberger anxiety will be completed again 15 to 20 minutes after ‎intervention. In the control group all procedures are same but Instead of lavender oil, we use distilled water. ‎

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040816797N2
Registration date: 2016-04-21, 1395/02/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Hossein Ashtarian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 2052
Email address
hashtarian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences‎
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of essential oil of Citrous Aurantium aromatherapy on anxiety of Patients who underwent coronary angiography
Public title
Effect of essential oil of Citrous Aurantium aromatherapy on anxiety of Patients who underwent angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Doing coronary angiography for the first time; There isn’t emergency situation; No operation has been done before and during angiography; No record of Allergic Rhinitis, Eczema or respiratory problems such as asthma and no olfactory ‎dysfunction; No medical or uncontrolled infection disorder; Being aware of time, place and subject; Patient ‎agreement for participating in study; No diagnosed mental illness; No drug addiction; the age between 30 to ‎‎75; Stable of vital signs; Having no pain at the time of interview and completing questioner; The ability to ‎speak Persian; Gaining more than 20 of the Spielberg State-anxiety questionnaires score. Exclusion criteria: Using sedative drugs without prescription ‎during study; Patients suffering cardiac dysrhythmia, ventricular fibrillation, Ventricular tachycardia and ‎cardiogenic shock; No cooperation during the study; Sensitivity to Citrous Aurantium.‎
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University Of Medical Sciences
Street address
Shahid Beheshti Blvd., Branch of researchs and industry of Kermanshah University Of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
kums.rec.1394.435

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention, 15 to 20 minutes after intervention
Method of measurement
The questionnaire of Spielberger anxiety ‎

Secondary outcomes

empty

Intervention groups

1

Description
The first group (aromatherapy): The questionnaire of demographic information and Spielberger anxiety are ‎completed before intervention. Then 4 milliliter of pure Citrous Aurantium oil which were dripped on tissue, will be ‎breathed by patients before angiography. Then the questionnaire of Spielberger anxiety will be completed again 15 to 20 minutes after ‎intervention. In the second group (control): all procedures are same but Instead of lavender oil, we use distilled water. ‎
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Hossein Ashtarian
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences‎
Full name of responsible person
Hossain Karim
Street address
Kermanshah, Kermanshah University of Medical Sciences‎, Branch of researchs and industry.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences‎
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Hossein Ashtarian
Position
PhD, Academic staff of School of Nursing and Midwifery
Other areas of specialty/work
Street address
Kermanshah, Dolat Abad Blvd., Kermanshah University of Medical Sciences, School of Nursing and Midwifery. ‎
City
Kermanshah
Postal code
Phone
+98 83 3827 9796
Fax
Email
hashtarian@kumsac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences. ‎
Full name of responsible person
Hossein Ashtarian
Position
PhD of Health Education
Other areas of specialty/work
Street address
Kermanshah, Dolat Abad, School of Nursing and Midwifery.
City
Kermanshah
Postal code
Phone
+98 83 3827 9796
Fax
Email
hashtarian@kumsac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hossein Ashtarian
Position
PhD of Health Education/Faculty member
Other areas of specialty/work
Street address
Kermanshah, Dollat Abad, School of Nursing and Midwifery
City
Kermanshah
Postal code
6714673945
Phone
+98 83 3826 2052
Fax
Email
Web page address
hashtarian@kums.ac.ir

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
Loading...