Anxiety and stress is one of the factors that increases mortality risk in the patients with heart disease. The aim of this study is to assess the effect of inhalation aromatherapy on the anxiety level of patients who are candidate for coronary artery bypass graft. Design of this study is a randomized controlled clinical trial. A total of 90 patients with age of 40-80 years old; without history of mental illnesses, epilepsy, asthma, thyroid dysfunction, olfactory dysfunction, allergy to the odor of the plants specially plants of orange and Lavender, smoking and drug addiction were selected. Then the samples randomly were allocated in to three groups: control group who inhaled the usual odor of the ward; experimental group(1) who inhaled cotton containing two drops of 100% Lavender essential oil and experimental group(2) who inhaled cotton containing two drops of 100% orange essential oil. The interventions were performed on the morning of the surgery. In order to data collection at first, at the day before surgery, the DASS questionnaire was filled out by the patients and physiologic criteria were assessed by the nurse. Again these stages were performed immediately and 30 minutes after the interventions. In this study, primary outcome measures are anxiety and stress and secondary outcome measures are blood pressure, pulse, respiration and depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309307565N2
Registration date:2014-01-11, 1392/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-11, 1392/10/21
Registrant information
Name
Nahid Rajai
Name of organization / entity
Tehran University of Medical Sciences, Nursing College
Country
Iran (Islamic Republic of)
Phone
+98 21 3330 6949
Email address
n-rajai@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
AJA university of Medical Science
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2014-04-09, 1393/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation aromatherapy on anxiety level of patients candidate for Coronary Artery Bypass Graft (CABG)
Public title
Effect of inhalation aromatherapy on anxiety level of the patients candidate for Coronary Artery Bypass Graft (CABG)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 40 - 80 years old; being literate; without history of mental illnesses, epilepsy, asthma, thyroid and olfactory dysfunction, allergy to the odor of plants specially plants of orange and Lavender, smoking and drug addiction, mechanical ventilation at the time of study; the first experience of surgery of coronary artery bypass graft; willingness to participant in the study.
Exclusion criteria: refuse to continue corporation in this study.
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AJA university of Medical Science
Street address
AJA university of Medical Science, next to Emam Reza hospital, Etemadzadeh street, west Fatemi street.
City
Tehran
Postal code
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
9210
Health conditions studied
1
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
151.6
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
The day before surgery, immediately after intervention and 30 min after intervention
Method of measurement
DASS questionnaire
2
Description
Stress
Timepoint
The day before surgery, immediately after intervention and 30 min after intervention
Method of measurement
DASS questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
The day before surgery, immediately after intervention and 30 min after intervention
Method of measurement
Sphygmomanometer
2
Description
Respiratory rate
Timepoint
The day before surgery, immediately after intervention and 30 min after intervention
Method of measurement
Counting the chest movements
3
Description
Pulse
Timepoint
The day before surgery, immediately after intervention and 30 min after intervention
Method of measurement
Counting the radial pulse
4
Description
Depression
Timepoint
The day before surgery, immediately after intervention and 30 min after intervention
Method of measurement
DASS questionnaire
Intervention groups
1
Description
In the experimental group (1): At once, a piece of cotton was placed inside the container of 10 cc and using a dropper, two drops of 100 % Lavender essential oil were poured on the cotton. Then, the container was given to the patient and asked to smell it from a distance of 5 cm of the nose, for 20 min.
Category
Prevention
2
Description
In the experimental group (2): At once, a piece of cotton was placed inside the container of 10 cc and using a dropper, two drops of 100 % orange essential oil were poured on the cotton. Then, the container was given to the patient and asked to smell it from a distance of 5 cm of the nose, for 20 min.
Category
Prevention
3
Description
In the control group: patients didn’t receive any special intervention and they just smell usual odor of the ward.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fajr hospital
Full name of responsible person
Street address
Fajr hospital, Fajr street, Piroozi street.
City
Tehran
2
Recruitment center
Name of recruitment center
Army 502 hospital
Full name of responsible person
Street address
Army 502 hospital, the corner of Bahar street, Taleghani street.
City
Tehran
3
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Street address
Besat hospital, Hejrat boulevard, Takhti three ways, Afsarieh autobahn.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
MS Nakhai
Street address
AJA University of Medical Sciences, next to Imam Reza hospital, Etemadzadeh street, west Fatemi street, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA 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
AJA Faculty of Nursing
Full name of responsible person
Nahid Rajai
Position
Master of Neonatal Intensive Care
Other areas of specialty/work
Street address
AJA Faculty of Nursing, next to the Family hospital, kaj street, Shariati street.
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
nahid.rajai@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
AJA Faculty of Nursing
Full name of responsible person
Nahid Rajai
Position
Master of Neonatal Intensive Care
Other areas of specialty/work
Street address
AJA Faculty of Nursing, next to the Family hospital, Kaj street, Shariati street.
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
nahid.rajai@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AJA Faculty of Nursing
Full name of responsible person
Nahid Rajai
Position
Master of Neonatal Intensive Care
Other areas of specialty/work
Street address
AJA Faculty of Nursing, next to the Family hospital, kaj street, Shariati street.
City
Tehran
Postal code
Phone
00
Fax
Email
n-rajai@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)