Protocol summary

Summary
This study will be conducted on 186 students of in Arak University of Medical Sciences. Sampling methods is convenient in the girl's dormitory. After approval of ethics committee and obtaining written consent from the students, they are assessed by anxiety test one week before the intervention. If anxiety is proven, they randomly assigned in intervention or control groups. In case group Aromatherapy will be performed with essence of lavender .Samples will inhale 5-6 drops of lavender essential oil concentration of 10% .So that a box with some cotton dipped in essence place at a distance of 70-10 cm and it is inhaled during sleep for five minutes (once per night) . Intervention, one week before the test started and after that anxiety once will assess after 7 night following inhalation . In the control group does not perform such an intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105101557N4
Registration date: 2011-06-25, 1390/04/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-06-25, 1390/04/04
Registrant information
Name
Katayon Vakilian
Name of organization / entity
Arak University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3502
Email address
k_vakili@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-01-19, 1390/10/29
Expected recruitment end date
2013-01-18, 1391/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Essence of Lavender in Anxiety Test in female student in Medical science of Arak University
Public title
The effect of Essence of Lavender in Anxiety Test in female student in Medical science of Arak University
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Unmarried, female students, residential in dormitory and associate and bachelor's degree; no history of mental illness and depression, acute stress (such as crises such as lost relatives and close friends ..), lack of family problems like divorce, which requires having anxiety with medical treatment at least three months before study and not having the test at the time of acute disease such as influenza and chronic diseases (diabetes ..) Exclusion Criteria: Being roommate of two study participants.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 186
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Sience and Health Service of Arak University
Street address
Medical Sience and Health Service of Arak University-Pardis-Arak
City
Arak
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90-105-4

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
At first assess before inhalation, after that evalute 7 night after inhalation
Method of measurement
Anxiety Test Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Case group: inhalation of lavender essence % 10 concentrate every night for 7 night for 5 minute.
Category
Treatment - Drugs

2

Description
Control group: Without any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical Science and Health Service of Arak University
Full name of responsible person
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medical science and Health service OF Arak University-Pardis-Sardasht,Arak
Full name of responsible person
Changiz Ashtiyan
Street address
Medical science and Health service OF Arak University-Pardis-Sardasht,Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical science and Health service OF Arak University-Pardis-Sardasht,Arak
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
Medical science and Health Service Of Arak University
Full name of responsible person
Katayon Vakilian
Position
Faculty Member
Other areas of specialty/work
Street address
Medical science and Health Service Of Arak University-Pardis-Sardasht Arak
City
Arak
Postal code
Phone
+98 86 1417 3502
Fax
+98 86 1417 3524
Email
cattyv2002@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical science and Health Service Of Arak University
Full name of responsible person
Katayon Vakilian
Position
Faculty Member
Other areas of specialty/work
Street address
Medical science and Health Service Of Arak University-Pardis -Sardasht Arak
City
Arak
Postal code
Phone
+98 86 1417 3502
Fax
+98 86 1417 3524
Email
Cattyv2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical Science and Health Service Of Arak University
Full name of responsible person
Katayon Vakilian
Position
Faculty Member
Other areas of specialty/work
Street address
Medical Science and Health Service Of Arak University-Pardis -Sardasht-Arak
City
Arak
Postal code
Phone
+98 86 1417 3502
Fax
Email
cattyv2002@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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