Protocol summary

Study aim
Determining the effect of aromatherapy on test anxiety of Nursing student
Design
Clinical trail with parallel control group , double-blind, randomized
Settings and conduct
The study was conducted in Karaj and in the Islamic Azad University of Nursing
Participants/Inclusion and exclusion criteria
absence of olfactory disturbances, asthma, allergies, rhinitis, upper respiratory tract infections, pregnancy, neurological or psychological problems.
Intervention groups
Before the OSCE , students in the experimental and control groups were quarantined in two classes. Demographic information form and the Sarason test anxiety questionnaire were filled out by both groups. The inhalation aromatherapy was performed for the students of the experimental group. a mixture of lavender, rosemary and peppermint oil was used for experimental group. It should be noted that for the intervention group, the person who did not participate in the intervention was given three drops of rosemary oil, three drops of rosemary and three drops of mint on the disposable non-absorbent tissue in such a way that it was not recognizable to the presenter and also to the people being studied. Each student was given a napkin to inhale. No intervention was performed on the control group students.
Main outcome variables
test anxiety after aromatherapy

General information

Reason for update
Acronym
OSCE
IRCT registration information
IRCT registration number: IRCT20200620047843N1
Registration date: 2020-08-26, 1399/06/05
Registration timing: retrospective

Last update: 2020-08-26, 1399/06/05
Update count: 0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
maryam khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4444 1048
Email address
m.khosravi@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-27, 1398/11/07
Expected recruitment end date
2020-01-27, 1398/11/07
Actual recruitment start date
2020-01-27, 1398/11/07
Actual recruitment end date
2020-01-27, 1398/11/07
Trial completion date
2020-01-27, 1398/11/07
Scientific title
Effect of Aromatherapy on test anxiety in objective structured clinical examinations, among nursing student.
Public title
Effect of Aromatherapy on test anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nursing students of the 8th semester of the Islamic Azad University, Karaj Branch Age limit 20-35 years
Exclusion criteria:
Suffering from asthma Suffering from allergies Suffering from rhinitis Suffering from upper respiratory tract infections psychological problems pregnancy
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study was simple with random allocation Based on the list of nursing students and using a table of random numbers, the first number selected from the list of students' class was placed in the experimental group and thus the second number was placed in the control group. The samples were divided into two groups until the number of samples was completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Prior to the OSCE exam, students in the experimental and control groups were quarantined in two separate classes. Considering the size of the class, three drops of lavender, rosemary and peppermint oil were poured on a non-absorbent cloth by a person who did not participate in the intervention and placed on each student's chair. It was placed at a distance of 15-20 cm from the student's nose. After placing the fabrics, we waited 15 minutes for the scent to spread evenly in the space, after which the students were led into the classroom. In such a way that the type of inhaled material on the fabric could not be identified and no intervention was done for the control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University science and research branchcenter
Street address
Alborz Province, Karaj, Rajai Shahr، Moazzen Boulevard
City
Tehran
Province
Tehran
Postal code
1473856314
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.IAU.SRB.REC.1398.174

Health conditions studied

1

Description of health condition studied
test anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
score of test anxiety in sarason questioner
Timepoint
At the beginning of the study (before the intervention) and 15 minutes after the intervention
Method of measurement
Sarason's test anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, the demographic information form and the Saranson exam anxiety questionnaire were first filled by students. The aromatherapy was then performed for 15 minutes. The inhalation aromatherapy was performed for the students of the experimental group. In order to perform aromatherapy in this study, a mixture of lavender, rosemary and mint oil was used. Considering the class size, three drops of lavender, rosemary and mint oil were poured on a non-absorbent cloth and placed on each student's chair. It was possible to be 15-20 cm away from the student's nose. After placing the fabrics, we waited 15 minutes for the scent to spread evenly throughout the space, after which the students were led into the classroom. Fifteen minutes after the aromatherapy, Saranson's anxiety test questionnaire was refilled by the students.
Category
Treatment - Other

2

Description
Control group: No intervention was performed for control group students
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Karaj Branch, Faculty Of Medical Sciences
Full name of responsible person
Maryam Khosravi
Street address
Alborz Province, Karaj, Rajai Shahr، Moazzen Boulevard
City
Karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3441 8163
Email
Info@kiau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Sabet
Street address
Alborz Province, Karaj, Rajai Shahr، Moazzen Boulevard
City
Karaj
Province
Alborz
Postal code
1473856314
Phone
+98 21 4444 1048
Email
Maryamkhosravi669@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Khosravi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Alborz Province, Karaj, Rajai Shahr، Moazzen Boulevard
City
Tehran
Province
Tehran
Postal code
1473856314
Phone
+98 21 4444 1048
Email
Maryamkhosravi669@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Khosravi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Alborz Province, Karaj, Rajai Shahr، Moazzen Boulevard
City
Tehran
Province
Tehran
Postal code
1473856314
Phone
+98 21 4444 1048
Email
Maryamkhosravi669@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Khosravi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Alborz Province, Karaj, Rajai Shahr، Moazzen Boulevard
City
Tehran
Province
Tehran
Postal code
1473856314
Phone
+98 21 4444 1048
Email
Maryamkhosravi669@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the publication of the article, confidential information such as the details of the participants will be deleted and other information will be provided to the researchers.
When the data will become available and for how long
after publishing the article
To whom data/document is available
Medical and nursing specialists
Under which criteria data/document could be used
Medical and nursing specialists can access data for academic purposes
From where data/document is obtainable
Refer to the email of the corresponding author
What processes are involved for a request to access data/document
Official and academic email to the corresponding author
Comments
no
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