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Investigation the effect of inhalation aromatherapy with blending essential oil of Lavender and Rose on test anxiety level in nursing student of Hormozgan university of medical scineces, 2017

Protocol summary

Summary
Objectives: This study will be done to investigate the effect of aromatherapy on test anxiety level of the nursing students of Hormozgan University of Medical Sciences by using a blend of lavender and rose essential oil. Design: Parallel. Setting and conduct: This study is a two-group randomized clinical trial. The participants will be 70 nursing students of Hormozgan University of Medical Sciences that have the inclusion criteria and will take their final examination on individual, family, and community health nursing. Having obtained the participants’ consent, they will randomly be divided into two equal-in-number groups. One will receive a blend of lavender and rose essential oil, while the other group will receive sesame oil. The physiological parameters will be recorded before the treatment, 15 minutes after it, and at the end of the examination, using the STAI anxiety questionnaire. Participants including: The criteria include the subjects tendency to participate in the study; the subjects not having impaired sense of smell; the subjects not reporting having asthma and allergies to flowers, respiratory disease, heart problems, epilepsy, skin diseases, and psychological disorders; the subjects not using aromatherapy and other complementary medicine techniques such as progressive muscle relaxation, music therapy and the like for a period of six weeks before their examination to reduce test anxiety; and the subjects not using anti-anxiety drugs and herbal medicines for a period of six weeks before their examination. The Exclusion criteria: the firm's unwillingness to continue the study; the subjects showing signs of allergy to rose and lavender essential oil during the study or feeling bad during the treatment; The appearance of any symptoms in the subjects resulting in their inability to continue the experiment. Intervention: The experimental group will receive a 10% blend of rose (3 drops) and lavender (7 drops), while the control group will receive 10 drops of odorless sesame oil on a piece of non-absorbent fabric attached to the arms of their chairs. Main outcome measures: Anxiety, physiological parameters including systolic blood pressure, diastolic blood pressure, respiration, and pulse.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041533430N1
Registration date: 2017-05-31, 1396/03/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Narges Hashemi
Name of organization / entity
Hormozgan University of Medical Scienses.
Country
Iran (Islamic Republic of)
Phone
+98 31 5240 5202
Email address
ahemi94nm106@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hormozgan University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of inhalation aromatherapy with blending essential oil of Lavender and Rose on test anxiety level in nursing student of Hormozgan university of medical scineces, 2017
Public title
Investigation the effect of inhalation aromatherapy on test anxiety level
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The subjects should tend to participate in the study; The subjects should not have impaired sense of smell; The subjects should not have asthma and allergies to flowers, respiratory disease, heart problems, epilepsy, skin diseases, and psychological disorders; The subjects should not have used aromatherapy and other complementary medicine techniques such as progressive muscle relaxation, music therapy and the like to reduce test anxiety for a period of six weeks before their examination. And finally, the subjects should not have used anti-anxiety drugs and herbal medicines during that period. Exclusion criteria: The firm's unwillingness to continue participating in the study; The subjects showing signs of allergy to rose and lavender essential oil during the study or feeling bad during the treatment; The appearance of any physical symptoms in the subjects resulting in their inability to continue the experiment.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Vice chancellor for research, SHahid Mohammadi Hospital, Islamic Republic of Iran Blvd, Bandar Abbas, Hormozgan, Iran.
City
Bandar Abbas
Postal code
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
HUMS.REC.1396.005

Health conditions studied

1

Description of health condition studied
Test anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is

Primary outcomes

1

Description
Test anxiety
Timepoint
Before the intervention, 15 min after the intervention, at the and of the exam.
Method of measurement
Spielberger state-trait

Secondary outcomes

1

Description
Systolic BP
Timepoint
Before the intervention, 15 minutes after the intervention, at the end of the exam.
Method of measurement
Manometer

2

Description
Diastolic BP
Timepoint
Before the intervention, 15 minutes after the intervention, at the end of the exam.
Method of measurement
Manometer

3

Description
Pulse rate
Timepoint
Before the intervention, 15 minutes after the intervention, at the end of the exam.
Method of measurement
CHronometer

4

Description
Breath rate
Timepoint
Before the intervention, 15 minutes after the intervention, at the end of the exam.
Method of measurement
CHronometer, Chest movement

Intervention groups

1

Description
Intervention 1: In the experimental group, the demographic and STAI anxiety questionnaires will be completed, and the physiological parameters will be recorded before the treatment. Fifteen minutes before the students’ entrance, 3 drops of rose essential oil 10% and 7 drops of lavender essential oil 10%, on a piece of non-absorbent fabric will be attached to the arms of their chairs. Before the treatment, 15 minutes after it, and at the end of the examination, the anxiety inventory STAI and the physiological parameters will be measured. The pads will not be removed from the chairs and no more drops will be added until the exam session ends.
Category
Prevention

2

Description
Intervention 2: In the placebo group, the demographic and the STAI anxiety questionnaires will be completed, and the physiological parameters will be recorded before the treatment. Fifteen minutes before the students’ entrance, 10 drops of sesame oil on a piece of non-absorbent fabric will be attached to the arms of their chairs. Fifteen minutes after the students’ entrance, the STAI anxiety questionnaire will be completed again and the physiological parameters will be measured. The pads will not be removed from the chairs and no more drops will be added until the exam session ends.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of nursing and midwifery of Hormozgan University of Medical Sciences
Full name of responsible person
Narges Hashemi
Street address
Nursing group, Faculty of nursing and midwifery, Resalat Jonubi street, Bandar Abbas, Hormozgan, Iran.
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hormozgan University of Medical Sciences
Full name of responsible person
Doctor Teamur Aghamolaei
Street address
Islamic Republic of Iran Blvd, SHahid Mohammadi Hospital, Vice chancellor for research.
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hormozgan 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
Faculty of nursing and midwifery
Full name of responsible person
Narges Hashemi
Position
Master of nursing studen
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Resalat Jonubi, Bandar Abbas, Hormozgan, Iran.
City
Bandar Abbas
Postal code
Phone
+98 31 5240 5202
Fax
Email
setare137093@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of nursing and midwifery
Full name of responsible person
Narges Hashemi
Position
Master of nursing student
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Resalat Jonubi street, Bandar Abbas, Hormozgan, Iran.
City
Bandar Abas
Postal code
Phone
+98 31 5240 5202
Fax
Email
setare137093@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
faculty of nursing and midwifery
Full name of responsible person
Narges Hashemi
Position
Master of nursing student
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Resalat Jonubi street, Bandar Abbas, Hormozgan, Iran,
City
Bandar Abas
Postal code
Phone
+98 31 5240 5202
Fax
Email
Setare137093@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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