Abstract
Objectives: The present study has been conducted with the objective of investigating the effect of lavender essential oil on the anxiety, hemodynamic changes, and pain using the aromatherapy method.
Acceptance criteria Contains: grade 1 and 2 elective surgery with general anesthesia; the absence of cardiovascular disease and chronic diseases such as diabetes, hypertension and COPD (breathing problems); neurological or allergic; Having ages between 18 - 40 years.
Exclusion criteria Contains: Patients within 24 hours of sedatives, narcotics, housing; also symptoms of hives have no history of allergy; as well as multiple attempts (more than 1 times) in intubation.
Methods: This single-blinded clinical trial study was performed on 64 patients candidate for surgery with average anxiety score (46-56). The samples were divided into two equal groups (N=32 in each group). The first group had lavender aromatherapy for 20 min and the second group had aromatherapy with distilled water for 20 min. Finally, the levels of hemodynamic changes, were investigated using the Spielberger State-Trait Anxiety (STAI) questionnaire once at the night before surgery and once on the day of surgery after aromatherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120229870N2
Registration date:2017-09-18, 1396/06/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-18, 1396/06/27
Registrant information
Name
Reza Heydarifar
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 748 3621
Email address
rheidarifar@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy lavender and initial training on anxiety before surgery
Public title
The effect of lavender and initial training on anxiety before surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Sample acceptance criteria including grade 1 and 2 elective surgery with general anesthesia; the absence of cardiovascular disease and chronic diseases such as diabetes, hypertension and COPD (breathing problems), neurological or allergic ; age is 18-40 years
Exclusion criteria: patients within 24 hours of sedatives, narcotics, housing ; communicate with their patients after induction difficult ;also symptoms of hives have no history of allergy; as well as multiple attempts (more than 1 times) in intubation ;the age of more than 50 and less than 20 ;patients who have respiratory problems and asthma and smell problems
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Vanak, Vanak Square, St. Molla Sadra, Baqiyatallah hospital
City
Tehran
Postal code
Approval date
2015-10-26, 1394/08/04
Ethics committee reference number
IR.BMSU.REC.1394.175
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Hemodynamic changes
Timepoint
Once before the surgery and continued respectively 13,10,1 and 15 minutes after intubation
Method of measurement
monitoring
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group for 20-10 minutes to inhale the aroma gauze containing two drops of essential oil
Category
Treatment - Drugs
2
Description
Intervention in the control group for 20-10 minutes inhaling sterile gauze containing two drops of water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother Hospital
Full name of responsible person
Reza Heydarifar
Street address
Alley 7, Dureshahr St
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Mehdi Mesri
Street address
Baqiyatallah Hospital, St. Molla Sadra, Vanak Square, Vanak
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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Reza Heydarifar
Position
BS Anesthesiology
Other areas of specialty/work
Street address
Baqiyatallah Hospital, St. Molla Sadra, Vanak Square, Vanak
City
Tehran
Postal code
Phone
+98 25 3773 0504
Fax
Email
reza.he68@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Reza Heydarifar
Position
BS Anesthesiology
Other areas of specialty/work
Street address
Baqiyatallah Hospital, St. Molla Sadra, Vanak Square, Vanak
City
Tehran
Postal code
Phone
+98 25 3773 0504
Fax
Email
reza.he68@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Reza Heydarifar
Position
BS Anesthesiology
Other areas of specialty/work
Street address
Baqiyatallah Hospital, St. Molla Sadra, Vanak Square, Vanak
City
Tehran
Postal code
Phone
+98 25 3773 0504
Fax
Email
reza.he68@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)