We will conduct a single-blind randomized controlled trial to investigate the effect of inhalation aromatherapy with rose essential oil on the level of anxiety in patients before coronary artery bypass graft surgery. 66 patients will participate in this study and will divide into control and test groups. The patients in the test group, will inhale three drops of 4% rose essential oil that produced by Barij Essen's Co. Iran (kashan) for 10 min night and morning before surgery and the patients in control group will be done routine cares. The level of anxiety will evaluated by Spielberger's Anxiety questionnaire before and 30 minutes after intervention in the control and test groups. Main inclusion criteria are desiring to participate in the study, Insensitivity to essential oils and aromas, have age Equal or above 18 years old , be candidate for coronary bypass graft surgery. Main Exclusion criteria include showing allergy to rose essential inhalation during the study, Occurrence of respiratory problems during intervention, unwillingness to participate in or continue the study.
In this study will investigated the effect of inhalation aromatherapy with rose essential oil on the level of anxiety in patients before coronary artery bypass graft surgery
General information
Acronym
؛
IRCT registration information
IRCT registration number:IRCT2017091919677N5
Registration date:2017-11-13, 1396/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-13, 1396/08/22
Registrant information
Name
Ravanbakhsh Esmaeili
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7345
Email address
r.esmaeili@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mazandaran University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation aromatherapy with rose essential oil on anxiety level in patient undergoing coronary surgery
Public title
The effect of inhalation aromatherapy with rose essential oil on anxiety level in patient undergoing coronary surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The desire to participate in the study؛ Insensitivity to essential oils and aromas؛ have age Equal or above 18 years old؛ be candidate for coronary artery bypass graft surgery.
Inclusion criteria: showing allergy to rose essential inhalation during the study؛ Occurrence of respiratory problems during intervention؛ unwillingness to participate in or continue the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The blocking method will be used for random allocation in groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran university of Medical sciences
Street address
Mazandaran university of medical science,vice chancellor for resea
City
SARI
Postal code
4764996893
Approval date
2017-09-13, 1396/06/22
Ethics committee reference number
IR Mazums. Rec.10234
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F50-F59
ICD-10 code description
Behavioural syndromes associated with physiological disturbances and physical
Primary outcomes
1
Description
Anxiety
Timepoint
Immediately before intervention,The night before the operation,one hour before operation
Method of measurement
spielberger Anxiety questionnaire
Secondary outcomes
1
Description
Respiratory sensation and shorthness of breath
Timepoint
The night before the operation,One hour before operation
Method of measurement
Self-report questionnaire on possible complications
Intervention groups
1
Description
intervention group: 3 drop of essential oils of 4% rose manufacturing of Pharmaceutical Company Barij essence with manufacturing number 714043, will be shed by the dropper on the non absorbent cotton and at a distance of 20 cm from the patients nose. This will be attached to the patients clothes.The patients will be reacquired to inhale the breath of the scent.
Category
Other
2
Description
Control group: The routine cares will be done in this patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Center Hospital
Full name of responsible person
Fatemeh Fazlollahpoor
Street address
Mazandaran Heart Center Hospital, Artesh Blvd, sari, Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi(vicor)
Street address
Vice Chancellor for Research Mazandaran University of Medical Sciences, Moalem Street, Moalem Square, Sari, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Mazandaran 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
Mazandaran University of Medical Sciences - Faculty of Nursing and Midwifery Nasseibeh