Objective: The aim of this study was to compare the effect of aromatherapy with roses and lavender on indices over time to remove the endotracheal after heart surgery has been opened
Inclusion criteria: patients undergoing open heart surgery, would like to participate in the study, aged more than 18 and less than 70 years, with heart rate greater than 60 beats per minute and systolic blood pressure greater than 90 mm Hg and a lack of sensitivity to any Which is of fragrances.
Exclusion criteria: any conditions that violate the inclusion criteria.
Study population: patients undergoing open heart surgery in the hospital Baqiyatallah in Tehran.
Sample size: The number of samples was estimated based on 160 samples that were divided into four groups.
Intervention :In this study, using aromatherapy with Rose and Lavender after open heart surgery and transfer Cardiac intensive care unit seeks to intervene for the pain and anxiety in patients and physiological Index to study and Extubation Time. This study was conducted on 01/09/1394 up to 06/01/1395
Primary outcomes: reducing pain, anxiety, physiological stability and reduced time in the endotracheal tube is in open heart surgery patients
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510012730N9
Registration date:2016-10-23, 1395/08/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Hosein Mahmoudi
Name of organization / entity
Baqiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6039
Email address
h.mahmoudi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
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
Comparison the Effect of Aromatherapy with Rose oil and Lavender on Physiological Indexes and Extubation after Open Heart Surgery
Public title
Comparison the Effect of Aromatherapy with Rose oil and Lavender on Physiological Indexes and Extubation after Open Heart Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
معیارهای ورود به مطالعه: بیماران کاندید جراحی قلب باز(شامل مشکلات عروق کرونر،اختلالات مادرزادی، جراحی های دریچه ای و ترمیمی)؛ تمایل به شرکت در مطالعه ؛محدوده سنی بیشتر از 18 و کمتر از 70 سال ؛دارا بودن ضربان قلب بیشتر از 60 بار در دقیقه وفشار خون سیستولیک بیشتر از 90 میلی متر جیوه ؛ تحت عمل جراحی قرار گرفتن برای اولین بار ؛ ؛ نداشتن مشکلات انعقادی (ACT < 2.5)
معیارهای خروج از مطالعه: بیماران روانی ؛ حساسیت به هر کدام از رایحه ها ؛ عمل جراحی قلب باز اورژانسی ؛ بازگشت مجدد به اتاق عمل
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Baqiyatallah University of Medical Sciences,
Street address
Molasadra Street Shikh Bahai Street Vanak Street
City
Tehran
Postal code
1435916471
Approval date
2010-11-01, 1389/08/10
Ethics committee reference number
IR.Bmsu.REc.1394.141
Health conditions studied
1
Description of health condition studied
CARDIAC SURGERY
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
physiological paramrtrs
Timepoint
After entering the patient to the intensive care unit of the first patient began to breathe a moment and then every half hour until the removal of the endotracheal tube and the tracheal tube after every fifteen minutes
Method of measurement
Blood pressure and heart rate using Cardiac Monitoring System Detex Omeda made in Finland and breathing with a ventilator device 840 is measured Made in America
2
Description
Extubation Time
Timepoint
The length of time that the patient has an endotracheal tube
Method of measurement
Cornometer
Secondary outcomes
empty
Intervention groups
1
Description
But in the control group without the intervention takes place after the first attempt Demi patient, every 30 minutes until you quit endotracheal tube and then every 15 minutes for one hour vital signs (pulse, respiration, blood pressure) and oxygen saturation arterial control and recorded
Category
Other
2
Description
With the completion of open heart surgery and then transfer the patient to the intensive care unit, starting with the first attempt inspiratory on the screen the mechanical ventilator, three drops of rose oil (experimental group 1) on a piece of gauze dropped and near the airway of the patient is placed and then every 30 minutes until you quit the endotracheal tube after tube removal, every 15 minutes for one hour vital signs (pulse, respiration, blood pressure) and oxygen saturation monitoring and recording is.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Hossein Babatabar Darzi
Street address
Molasadra Street .Shikh Bahai street .vanak Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
AliRahmani
Street address
Molasadra street shikh bahai Street .Vanak Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Nursig Colleage.Baqiyatallah University of Medical Sciences,
Full name of responsible person
Hossein Babatabar Darzi
Position
Master of anesthesia.Faculty
Other areas of specialty/work
Street address
Molasadra street Shikh Bahai Vanak Square
City
Tehran
Postal code
1435916471
Phone
+98 21 8248 3500
Fax
+98 21 8860 0047
Email
babatabar1343@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Colleage.Baqiyatallah University of Medical Sciences,
Full name of responsible person
Hossein Babatabar Darzi
Position
Master of Anesthesia
Other areas of specialty/work
Street address
Molasadra Street Shikh Bahai Street Vanak Square
City
Tehran
Postal code
1435916471
Phone
+98 21 8248 3500
Fax
+98 21 8860 0047
Email
babatabar1343@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing Colleage.Baqiyatallah University of Medical Sciences,
Full name of responsible person
Hossein Babatabar Darzi
Position
Master Of Anesthesia
Other areas of specialty/work
Street address
Molasadre Street SHikh Bahai Street Vanak Square
City
Tehran
Postal code
1435916471
Phone
+98 21 8248 3500
Fax
+98 21 8860 0047
Email
babatabar1343@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)