Protocol summary

Summary
According to some studies lavender scent improves mood and reduces stress and anxiety. The purpose of this study is to investigate the effect of lavender scent on anxiety status in women before D&C in an Educational Center affiliated to Gorgan Medical Sciences University in Golestan. This is a single blind clinical trial in which 112 women will be stratified randomly into two groups, each including 56 people, case group (N=56) and control group (N=56). The case group smells lavender essential oil for 1 hour before operation. In both groups anxiety changes will be determined before and after aromatherapy by Spielberger twenty-question questionnaire. Inclusion criteria include not to be emergent case and having the smelling ability and exclusion criteria include allergy to perfumes or any other sensitivity, chronic respiratory disease and underlying diseases.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012102510340N8
Registration date: 2013-02-21, 1391/12/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-21, 1391/12/03
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan university of medical sciences
Expected recruitment start date
2010-03-11, 1388/12/20
Expected recruitment end date
2011-07-14, 1390/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of essential oil of lavender (L. Lavandula officinalis) on preoperative anxiety in patients with curettage
Public title
The effect of Lavender on stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Lack of emergency; having completed pregnancy and having enough power to smell the scent. Exclusion criteria: being allergic to perfumes or any other sensitivity; chronic respiratory disease; underlying diseases.
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan university of medical sciences
Street address
Golestan university of medical science, Gorgan
City
Gorgan
Postal code
Approval date
2010-01-09, 1388/10/19
Ethics committee reference number
01388.010.019

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder

Primary outcomes

1

Description
anxiety
Timepoint
before surgery
Method of measurement
Spielberger questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: 40 mg Lavender essential oil 100% which will be smelled for 1 hour before operation.
Category
Treatment - Drugs

2

Description
Control: 2cc Distilled water and a small amount of lemon juice with a concentration of 1% which will be smelled for 1 hour before operation.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dezyani hospital
Full name of responsible person
Street address
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Mohamad Ali Vakili
Street address
Third floor, Golestan university of medical sciences, , Gorgan
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
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
Kazem Kazemejad
Position
anesthesiology
Other areas of specialty/work
Street address
Faculty of Health Sciences, Golestan university of medical sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 1654
Fax
Email
kazemnejad1341@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Mohamad Aryaie
Position
Master
Other areas of specialty/work
Street address
Third floor, Golestan university of medical sciences, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1442 4377
Fax
Email
m_aryaie2009@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Amin Hassanzad
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
hassanzad_amin@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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