Comparison the effect of inhalation of essential oils of jasmine with distilled water on the level of anxiety and blood cortisol of patients before laparotomy
The aim of this study is to evaluate the effect of inhalation of essential extraction (oil) of Jasmine on the level of anxiety and blood Cortisol of patients that are candidate for Laparotomy surgery. Inclusion criteria included: 65-15 year old, patients who are candidate for Laparotomy without a history of mental illness and no neurologic signs due to trauma, oriented to place, time and self, no history of allergy to plants, no disorder in smell, having ability to read and response to questionnaire items, no history of using steroid during 3 months ago, or those disease that increase the level of blood Cortisol. The study population are the patients who are waiting for Laparotomy in 5th Azar Hospital, 84 of them will participate in this study and they are randomly allocated in the intervention and controlled group. The subjects will sign a consent form before intervention.
Intervention: before intervention, the subjects' trait anxiety will be measured by a valid questionnaire and blood level of Cortisol will be measured through 2 ML blood sample. Then, the intervention group will take 2 drops of essential oil of Jasmine through dropping on patients collar for inhalation and control group will take two drops of distilled water through dropping on patients collar for inhalation. After 60 minutes the subjects' trait Anxiety and Cortisol will be measured again. Because the maximum effect of Jasmine occurs 60 minutes after inhalation. Intervention for all patients will be done between 7:30 to 8:30 am.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072510325N4
Registration date:2015-09-24, 1394/07/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-24, 1394/07/02
Registrant information
Name
Gholamreza Mahmoodi Shan
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
mahmoudi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
The funding source of the study is Research Vice-Chancellor (Research and Technology) Golestan University of Medical Sciences
Expected recruitment start date
2015-07-26, 1394/05/04
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of inhalation of essential oils of jasmine with distilled water on the level of anxiety and blood cortisol of patients before laparotomy
Public title
Jasmine impact on the levels of anxiety and cortisol exposure of patients to the operating room
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
65-15 years old, patients who are candidate for laparotomy without a history of mental illness and no signs of trauma to the brain, alert to place, time and self orientation, no history of allergy to plants, no disorder in smell, having ability to read and response to questionnaire items, no history of using steroid during 3 months ago, or those disease that increase the level of blood Cortisol.
Exclusion criteria:
Patient's intolerance due to Jasmine extraction, patient transmission before the intervention, the patient withdraw from the study, and the patients with anxiety or depression disorders.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the intervention and control group will be allocated randomly in two groups. Finally, there will be 42 cases in each one of the intervention and control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences.
Street address
Golestan University of Medical Sciences, Vice Chancellor for Research and Technology. Kilometr 4 Gorgan-Sari (initial of Shast Kola Road).
City
Gorgan
Postal code
4934174515
Approval date
2015-07-26, 1394/05/04
Ethics committee reference number
Ir.Goums.Rec 1394.56
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder.
Primary outcomes
1
Description
ََAnxiety
Timepoint
Before and one hour (60 minutes) after intervention the anxiety will be measured
Method of measurement
Spielberger questionnaire.
2
Description
Blood Cortisol
Timepoint
Before and one hour after intervention the subjects' blood samples will be taken and the level of Cortisol will be measured.
Method of measurement
Using ELISA monitors Cortisol IBl kit
Secondary outcomes
1
Description
Vital sign
Timepoint
Before and one hour after intervention.
Method of measurement
Blood pressure of the subjects will be measured before and after the intervention by a Manometer ALPK2 that was manufactured by Japan. The subjects' pulse rate and respiratory rate will be counted.
Intervention groups
1
Description
Group intervention:The subjects inhale two drops of essential oil of Jasmine Barij Essence Kashan product for 60 minutes. Jasmine will be dropped on the patient's shirt collar shed. The surgery will be done in the morning.
Category
Placebo
2
Description
Control group: inhale two drops of distilled water as a placebo for 60 minutes on the patient's shirt collar shed. Intervention will be held the morning of surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan 5th Azar Hospital.
Full name of responsible person
Mohamad Yadegari
Street address
5th Azar Hospital Gorgan, 5th Street Azar, Gorgan,Golestan.
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences Vice Chancellor for research
Full name of responsible person
Dr. Masood Khoshnia
Street address
Golestan University of Medical Sciences, Shastkola, Gorgan, Golestan.
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Sciences Vice Chancellor for research
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
Golestan University of Medical Sciences.
Full name of responsible person
Mohamad Yadegari
Position
MSc student of critical care nursing.
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola, Gorgan, Golestan.
City
Gorgan
Postal code
4934174515
Phone
+98 17 3242 6900
Fax
+98 17 3243 0353
Email
mahmoodigh@yahoo.commohamad.yadegari970@gmail.com
Web page address
http//goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Mahmoudi shan
Position
PHD, Assistant Professor
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola, Gorgan, Golestan.