Cardiac patients particularly myocardial infarction (MI) in acute phase and first 48 hours after hospitalization, experience a lot of anxiety and in compare to patients who have less anxious, afflicted by ischemia, recurrent MI, tachycardia and ventricular fibrillation 5 times higher. Also, hospital wards due to noise, alien environment, disrupting in sleep and etc. are stressor. One of the non-drug methods for decreasing of anxiety that has attracted a lot of attention in recent years is aromatherapy. However, our scrutiny showing that there is no study about Lavender aromatherapy effect on decreasing anxiety in heart ischemic patients, as yet. So, the aim of this study is determine to effect of essential oil of Lavender aromatherapy on anxiety and vital signs in heart ischemia patients who hospitalized in Imam Reza and Imam Ali Hospitals of Kermanshah University of Medical Sciences in 2014.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030216797N1
Registration date:2014-05-03, 1393/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-03, 1393/02/13
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
Research project approved by Kermanshah University of Medical Sciences.
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-08-06, 1393/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of essential oil of Lavender aromatherapy on anxiety and vital signs in heart
ischemia patients who hospitalized in CCU
Public title
Effect of essential oil of Lavender aromatherapy on anxiety and vital signs in heart ischemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: recorded the diagnosis of MI in accordance with physician diagnosis; Suffered from MI for the first time; 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 25 to 65; 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: To be under CPR on arrival at the ED (emergency department) and CCU; Using sedative drugs without prescription during study; Patients suffering cardiac dysrhythmia, ventricular fibrillation, Ventricular tachycardia and cardiogenic shock; No cooperation during the study; Patient death during the study; Sensitivity to lavender aroma.
Age
From 25 years old to 65 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
Kermanshah, Shahi Beheshti Blvd., Branch of researchs and industry of Kermanshah University Of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-01-08, 1392/10/18
Ethics committee reference number
49404
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, 15 to 20 minutes after intervention in two consecutive days
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 three drops of pure Lavender oil which were dripped on tissue, will be breathed by patients at 10 to 11 AM and 6 to 7 PM and each time for 20 minutes within two days (generally four sessions). Then the questionnaire of Spielberger anxiety will be completed again 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 Reza and Imam Ali Hospitals
Full name of responsible person
Hossein Ashtarian
Street address
Kermanshah, Kermanshah University of Medical Sciences, School of Nursing and Midwifery.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
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, Chief 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 1827 9796
Fax
Email
hashtarian@kums.ac.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 1827 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/Chief of School of Nursing and Midwifery
Other areas of specialty/work
Street address
Kermanshah, Dollat Abad, School of Nursing and Midwifery.
City
Kermanshah
Postal code
Phone
+98 83 1827 9796
Fax
Email
hashtarian@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)