Protocol summary

Summary
Objective: This study investigated the effects of oil of rose water, the exam anxiety is designed. Study design: simple Randomized, double-blind, placebo-controlled, study population: Paramedical College students living in dormitories. Main inclusion criteria: complete satisfaction to participate in the study and having enough power olfactory (smell is not deaf). Main exclusion criteria: allergy to perfumes and any other allergic asthma, chronic respiratory diseases, underlying disease (heart, blood pressure, etc.), anxiety disorders, according judgeship a clinical psychologist. Sample size: 80 students of the Faculty of Paramedical at the dormitory. Before starting the study under the supervision of a clinical psychologist and screening anxiety for Students interested in participating in the study using questionnaires can by VAS So will exclude from the study that participants with severe anxiety disorders. The night before the exam in the intervention group for 60 seconds will inhale the the essential oil of rose water And for persistence some of it the with applicator will be applied to the forehead students.And the control group in the same way with distilled water is colorless and odorless given to smell. Anxiety levels, blood pressure and heart rate are measured before and after the intervention. (C) the time intervention: intervention period beginning second semester of final exam study 2014-15 (d) Primary outcomes: test anxiety

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201403099697N3
Registration date: 2015-06-29, 1394/04/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Fozieh Bakhsha
Name of organization / entity
Golestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 3253 8011
Email address
bakhsha@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of essential oil of of rose water, the anxiety level students, School of Paramedical Sciences, Gorgan
Public title
Effect of essential oil of of rose water, the anxiety level students, School of Paramedical Sciences, Gorgan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: complete satisfaction to participate in the study; having enough power olfactory (smell is not deaf) will be. Major of Exclusion criteria: allergy to perfumes and any other type of asthma and allergies; chronic respiratory diseases; underlying disease (heart, blood pressure, etc.).
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, km 4 road Sari Gorgan, Gorgan, Golestan , Iran
City
Gorgan
Postal code
49341-74515
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
27962893111902

Health conditions studied

1

Description of health condition studied
anxity exam
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
anxity exam
Timepoint
Before the intervention and 30 minutes after the intervention
Method of measurement
Sarason Test Anxiety Scale

Secondary outcomes

1

Description
blood presure
Timepoint
Before the intervention and 30 minutes after the intervention
Method of measurement
According Mm hg By using Mercury sphygmomanometer

2

Description
pulse rate
Timepoint
Before the intervention and 30 minutes after the intervention
Method of measurement
From the measurement of the radial pulse in 60 seconds

Intervention groups

1

Description
The night before the exam in the intervention group Once a for 60 seconds will inhale the the essential oil of rose water And for persistence some of it the with applicator will be applied to the forehead students. Anxiety levels, blood pressure and heart rate are measured before and30 minutes later the intervention.
Category
Prevention

2

Description
The night before the exam placebo in the same shape, size and Methods as with intervention group Once a for 60 seconds by participants will smell And using an applicator for the will be applied to a person's forehead. Anxiety levels, blood pressure and heart rate are measured before and30 minutes later the intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Student Dormitory
Full name of responsible person
fozieh bakhsha
Street address
Third alley dormitories Martyrs December 5, December 5th Street, Gorgan, Golestan.
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Masoud khoshnia, Director of Vice Chancellor Research and Technology
Street address
Vice Chancellor for Research and Technology, Golestan University of Medical Sciences, km 4 road Sari Gorgan, Gorgan, Golestan, Iran
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
Fozieh Bakhsha
Position
MSc in Anesthesia,Instracter of Paramedical School
Other areas of specialty/work
Street address
Department of Anesthesiology, Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Km 4 road Sari-Gorgan, Gorgan, Golestan, Iran
City
Gorgan
Postal code
74515-49341
Phone
+98 17538011
Fax
+98 17 3242 3630
Email
Bakhsha@goums.ac.ir؛ Bakhsha_fo@yahoo.com؛ Bakhshafo@gmail .com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Fozieh Bakhsha
Position
MSc in Anesthesia, Instructor of Paramed
Other areas of specialty/work
Street address
Department of Anesthesiology, Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Km 4 road Sari-Gorgan, Gorgan, Golestan, Iran
City
Gorgan
Postal code
74515-49341
Phone
+98 17 3253 8011
Fax
+98 17 3242 3630
Email
Bakhsha@goums.ac.ir؛ Bakhsha_fo@yahoo.com؛ Bakhshafo@gmail .com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Fozieh Bakhsha
Position
MSc of Nurse Anesthesiology,Instructor, Director of Nure Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Faculty of Paramedical Sciences, Golestan University of Medical Sciences, Km 4 road Sari-Gorgan, Gorgan, Golestan, Iran
City
Gorgan
Postal code
74515-49341
Phone
+98 17 3253 8011
Fax
+98 17 3242 3630
Email
Bakhsha@goums.ac.ir؛ Bakhsha_fo@yahoo.com؛ Bakhshafo@gmail .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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