Protocol summary

Study aim
determining the effect of aromatherapy with damask rose essence on OSCE-related anxiety in anesthesia, operating room, and nursing students of Jahrom University of Medical Sciences
Design
Two parallel group randomised trial، blinded، through census and random number table, on 76 students, two stages of pre-test and post-test
Settings and conduct
This semi-experimental study will be conducted in Jahrom University of Medical Sciences. Students will be assigned to two intervention and control groups, and the level of anxiety before and after the intervention will be determined and compared. After obtaining informed consent and completing the demographic information form, both groups will move to two separate places, and the TAS questionnaire will be completed for the first time. Then, cotton soaked with two drops of 40% damask rose essence and distilled water (placebo) will be given to the intervention and control groups, respectively to inhale. The container of distilled water and damask rose essence is the same without a specification label, and labels A (damask rose essence) and B (distilled water) will be used to distinguish them. Then, the post-test (TAS Questionnaire the second time) will be completed 5 minutes after the end of the intervention.
Participants/Inclusion and exclusion criteria
Willingness to participate in research and complete the consent form, desire to smell damask rose, not having: diagnosed mental illness, history of anxiety disorders, disturbance in the sense of smell, chronic migraine headaches, chronic diseases including cardiovascular disease, epilepsy, skin disease, and allergy, allergy to the smell of plants
Intervention groups
intervention group: aromatherapy using essence of damask rose (inhalation of two drops of 40% damask rose essence ) control group: placebo (inhalation of two drops of distilled water)
Main outcome variables
anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210502051161N2
Registration date: 2024-02-04, 1402/11/15
Registration timing: prospective

Last update: 2024-02-04, 1402/11/15
Update count: 0
Registration date
2024-02-04, 1402/11/15
Registrant information
Name
Hamidreza Nejati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5372 3872
Email address
hamidrezaa891425@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-25, 1403/03/05
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating of the effect of aromatherapy with Damask Rose essence on the anxiety caused by the OSCE in anesthesia, operating room and nursing students
Public title
investigating the effect of aromatherapy with Damask Rose essence on students' anxiety caused by the OSCE test
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a diagnosed mental illness Not having a history of anxiety disorders Absence of disturbance in the sense of smell Absence of chronic migraine headaches Absence of underlying diseases including cardiovascular disease, epilepsy, skin disease and allergy No history of allergy to the smell of plants Willingness to participate in research and complete written informed consent to participate in the study The desire to smell the smell of roses
Exclusion criteria:
Leaving the exam site for any reason during the study intervention Lack of motivation of the research unit to continue cooperation Taking drugs that affect anxiety Use of perfume Incomplete completion of questionnaires Students with underlying diseases/asthma or seasonal allergies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research was simple with random allocation, in which based on the list of operating room, anesthesia and nursing students using a table of random numbers, the first selected number from the class list of students was placed in the test group and so on. The second number was placed in the control group. Allocation of samples in two groups continued until the number of samples was completed
Blinding (investigator's opinion)
Double blinded
Blinding description
The students of the test and control groups are placed in two separate places. In the test group, two drops of 40% rose essence are poured on cotton and given to the test group. For students in the control group, two drops of distilled water will be poured on the cotton as a placebo and will be provided to them. The bottle containing distilled water and rose essence will be of the same shape and none of them will have a specification label and will be marked with labels A (Damask rose essence) and B (distilled water) to distinguish them. Then the students are asked to inhale it from a distance of 5 cm for 10 minutes. In order to carry out this intervention and control the duration of inhalation, two people will be present in the room as observers, so that the observers after Delivery of cotton soaked with essential oil or distilled water to the students, they are informed that they will start inhalation and they will monitor the students using a timer for ten minutes. After ten minutes, the supervisors ask the students to stop inhalation and put the inhaled cotton balls in the bags placed on the chair handle. The intervention will be done before the start of the Asci test during the pre-test quarantine. And it is done first on the control group and then on the students of the test
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 Motahari Blvd., after Nursing Faculty, Jahrom University of Medical Sciences, Pardis site
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2023-06-13, 1402/03/23
Ethics committee reference number
IR.JUMS.REC.1402.021

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
The score obtained from the TAS questionnaire
Timepoint
Immediately before and five minutes after aromatherapy
Method of measurement
TAS questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before the intervention, the students of the test group are asked to answer Sarason's test anxiety questionnaire. In the test group, two drops of 40% rosehip essence, belonging to Barij Essan Company of Kashan, are poured on the cotton and given to the test group. Then the students are asked to smell it from a distance of 5 cm for 10 minutes. In order to carry out this intervention and control the duration of inhalation, two people will be present in the room as observers, in such a way that the observers after delivery Cottons soaked with essence are given to the students, they are informed that they will start inhalation and they will monitor the students using a timer for ten minutes. After ten minutes, the supervisors ask the students to stop inhalation and put the inhaled cotton balls in the bags placed on the chair handle. The intervention before the start of the Ascii test will be done during the pre-test quarantine. Then the test (Sarason Anxiety Questionnaire for the second time) will be completed 5 minutes after the end of the intervention, with the announcement of the supervisors.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahrom University of Medical Sciences
Full name of responsible person
Hamidreza Nejati
Street address
Jahrom University of Medical Sciences, end of Ostad Motahhari Blvd.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Fax
Email
Hamidrezaa891425@Gmail.com
Web page address
http://www.jums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Amir Abdoli
Street address
Jahrom University of Medical Sciences, end of Ostad Motahhari Blvd.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
info@gmail.com
Web page address
http://www.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
Hamidreza Nejati
Position
surgical Technologist
Latest degree
Master
Other areas of specialty/work
Operating room
Street address
Ostad Motahari St., Jahrom University of Medical Sciences, Pardis site
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 74 1484 6199
Email
Hamidrezaa891425@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Bahareh Mahdood
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Operating Room Training
Street address
Jahrom University of Medical Sciences, end of Ostad Motahhari Blvd.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
baharehmahdood68@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Hamidreza Nejati
Position
Surgical Technologist
Latest degree
Master
Other areas of specialty/work
Operating Room
Street address
Jahrom University of Medical Sciences, end of Ostad Motahhari Blvd.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
Hamidrezaa891425@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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