IRCT | The effect of aromatherapy with lavender oil and citrus limon on undergraduate students of the faculty of nursing and para-medicine anxiety before the post-internship Objective Structured Clinical Examination test (OSCE)

Protocol summary

Study aim: Determining and comparing the effect of aromatherapy with lavender and citrus limon essential oil on the anxiety of undergraduate students of nursing and paramedical faculties before the objective structured clinical examination (OSCE) at the end of the course at Jahrom University of Medical Sciences in the academic year 2023-2024
Design: A clinical trial has two intervention groups and one control group, with parallel groups, three-blinded, Census sampling method with random allocation by throwing dice
Settings and conduct: This study will be conducted in the Faculty of Nursing and Paramedicine of Jahrom University of Medical Sciences and the participants will be asked to be in classes according to the division. Sarason's anxiety questionnaire and vital signs will be recorded before entering the class, 15 minutes after being placed in the class and at the end of the test.
Participants/Inclusion and exclusion criteria: lack of respiratory allergies, lack of olfactory disorders, mental health, not using other stress reduction methods such as drug therapy, music therapy, etc., informed consent to participate in the study
Intervention groups: This study has three groups, intervention group with lavender, intervention group with citrus limon and control group. Each group is placed in a classroom that is completely clean and well ventilated. A few minutes before the groups are placed in the classes, a napkin containing 3 drops of the relevant essential oil will be placed on each chair. In the control group, 3 drops of distilled water will be placed on the napkins. Before entering classes,15 minutes after the participants are placed in the classes, and at the end of the test, data will be collected.
Main outcome variables: Test anxiety score before the intervention, 15 minutes after and after the test

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20130718014049N11

Registration date: 2024-01-07, 1402/10/17

Registration timing: registered_while_recruiting

Last update: 2024-01-07, 1402/10/17

Update count: 0
Registration date: 2024-01-07, 1402/10/17

Registrant information: Name

Ali Abbasi Jahromi

Name of organization / entity

Jahrom University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 79 1334 1501

Email address

abbasija@jums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-12-31, 1402/10/10
Expected recruitment end date: 2024-07-20, 1403/04/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of aromatherapy with lavender oil and citrus limon on undergraduate students of the faculty of nursing and para-medicine anxiety before the post-internship Objective Structured Clinical Examination test (OSCE)

Public title: The effect of aromatherapy with lavender oil and Citrus Limon on undergraduate students anxiety before the post-internship Objective Structured Clinical Examination test (OSCE)
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

All final year undergraduate students of nursing and paramedical faculties Consent to participate in the study

Exclusion criteria:

Having a respiratory sensitivity to the scent of lavender and citrus limon Having olfactory disorders Use of sedative drugs Using stress-reducing methods such as music therapy and... Having anxiety disorders
Age: From 18 years old to 25 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Outcome assessor
Data analyser

Sample size

Target sample size: 80

Randomization (investigator's opinion)

Randomized

Randomization description

The division will be random allocation based on the class list in such a way that the students number 1, 2 and 3 of the list of each class will be divided into the intervention group with lavender and the intervention group with citrus lemon and control, by throwing a dice and randomly. The rest of the students will be systematically divided into the above groups. Numbers 1 and 4 of the dice will be assigned to the intervention group with lavender, numbers 2 and 5 of the dice will be assigned to the intervention group with citrus lemon, and numbers 3 and 6 of the dice will be assigned to the control group. This process will be done for all groups.

Blinding (investigator's opinion)

Triple blinded

Blinding description

This is a triple-blind study, the nature of the essential oil is unknown to the study participant, Outcome assessor, and the data analyst.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Jahrom University of Medical Sciences

Street address

Ostad motahhary Blvd, Jahrom University of Medical Sciences

City

Jahrom

Province

Fars

Postal code

7414846199
Approval date: 2023-12-16, 1402/09/25
Ethics committee reference number: IR.JUMS.REC.1402.096

Health conditions studied

1

Description of health condition studied: Anxiety of undergraduate students before the Objective Structured Clinical Examination (OSCE) test at the end of the course
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Test anxiety score
Timepoint: Before the intervention, 15 minutes after the intervention, after the test
Method of measurement: Sarason questionnaire

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group:At the beginning of the research, the students' demographic information questionnaire will be filled and for the first time, Sarason's anxiety and vital signs questionnaire will be completed by each student. Then, the intervention group will be placed in a classroom that has been completely cleaned and properly ventilated. A tissue paper with 3 drops of lavender essential oil will be placed on each chair. The distance between these tissue papers and the nose of the participants will be 15 cm. 15 minutes after the placement of the students in the class, the Sarason and vital signs questionnaire will be completed again by the students, and finally, for the third time and after the test, the Sarason and vital signs questionnaire will be completed by each student after the test. Vital signs will be measured by Saadat model vital signs monitor and will be announced to the students.
Category: Treatment - Other

2

Description: Intervention group:At the beginning of the research, the students' demographic information questionnaire will be filled and for the first time, Sarason's anxiety and vital signs questionnaire will be completed by each student. Then, the intervention group will be placed in a classroom that has been completely cleaned and properly ventilated. A tissue paper with 3 drops of Citrus Limon L will be placed on each chair. The distance between these tissue papers and the nose of the participants will be 15 cm. 15 minutes after the placement of the students in the class, the Sarason and vital signs questionnaire will be completed again by the students, and finally, for the third time and after the test, the Sarason and vital signs questionnaire will be completed by each student after the test. Vital signs will be measured by Saadat model vital signs monitor and will be announced to the students.
Category: Treatment - Other

3

Description: Intervention group:At the beginning of the research, the students' demographic information questionnaire will be filled and for the first time, Sarason's anxiety and vital signs questionnaire will be completed by each student. Then, the intervention group will be placed in a classroom that has been completely cleaned and properly ventilated. A tissue paper with 3 drops of distilled water will be placed on each chair. The distance between these tissue papers and the nose of the participants will be 15 cm. 15 minutes after the placement of the students in the class, the Sarason and vital signs questionnaire will be completed again by the students, and finally, for the third time and after the test, the Sarason and vital signs questionnaire will be completed by each student after the test. Vital signs will be measured by Saadat model vital signs monitor and will be announced to the students.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Jahrom University of Medical Sciences

Full name of responsible person

Razieh Emadabadi

Street address

Ostad Motahari Blvd,Jahrom University of Medical sciences

City

Jahrom

Province

Fars

Postal code

7414846199

Phone

+98 71 5434 0405

Email

r.emadi69@gmail.com

1

Sponsor: Name of organization / entity

Jahrom University of Medical Sciences

Full name of responsible person

Amir Abdoli

Street address

Ostad Motahari Blvd, Jahrom University of Medical Sciences

City

Jahrom

Province

Fars

Postal code

7414846199

Phone

+98 71 5444 0821

Email

a.abdoli@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Jahrom University of Medical Sciences
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

Jahrom University of Medical Sciences

Full name of responsible person

Ali Abbasi jahromi

Position

Instructor, faculty member

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

Ostad Motahari Blvd, Jahrom University of Medical Sciences

City

Jahrom

Province

Fars

Postal code

7414846199

Phone

+98 71 5434 0406

Email

aliabbasijahromi@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Jahrom University of Medical Sciences

Full name of responsible person

Ali Abbasi jahromi

Position

Instructor, faculty member

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

Ostad Motaharie Blvd, Jahrom University of Medical Sciences

City

Jahrom

Province

Fars

Postal code

7414846199

Phone

+98 71 5434 0406

Email

aliabbasijahromi@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Jahrom University of Medical Sciences

Full name of responsible person

Razieh EmadAbadi

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Anesthesiology

Street address

Ostad Motaharie Blvd, Jahrom University of Medical Sciences

City

Jahrom

Province

Fars

Postal code

7414846199

Phone

+98 71 5434 0406

Email

r.emadi69@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: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document: IPD collected for the primary outcome measure only
When the data will become available and for how long: Six months after printing results
To whom data/document is available: Only available for people working in academic institutions
Under which criteria data/document could be used: Only scientific and practical use is allowed
From where data/document is obtainable: Jahrom University of Medical Sciences
What processes are involved for a request to access data/document: Apply to university and receive information
Comments

The effect of aromatherapy with lavender oil and citrus limon on undergraduate students of the faculty of nursing and para-medicine anxiety before the post-internship Objective Structured Clinical Examination test (OSCE)