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The effect of inhalation aroma with rosemary oils on stress, anxiety and job fatigue in emergency medical technicians

Protocol summary

Study aim
Investigating the effect of Rosemary oil inhalation on stress, anxiety and occupational fatigue of EMS personnel
Design
Clinical trials with control group, with parallel groups, randomized.The sample size will be totally 30 person at each group.8 bases will be selected.Then the numbers of the bases will be put into the container.By coin tossing, a number goes out of the container at the same time.Eventually and the bases will be in the groups.
Settings and conduct
At first, the cream chest badges made of linen, with the size of 3x5cm, will stuck to the uniform of the subjects.Then, the rosemary oil were made in the form of 20cc sprays, provide for group. Then, the groups will ask to spray 2 puffs of the essential oils on their badges exactly at 8 O’clock every morning . The essential oils will apply from 8 to 10 O’clock (2 hour) at 3 shifts per week for one month.The researcher will remind the subjects of the intervention .Finally, immediately and 30 days after the intervention, questionnaire will re-complete.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Do not use of anti-anxiety and anti-depressant drugs, Do not use perfumes and fragrances during the intervention,Lack of allergy and migraine and liver and kidney disease,No addiction ,health of the sense of smell.Exclusion criteria: history of allergies
Intervention groups
1-Intervention :The Badges will be installed within thirty centimeters of the nose.At 8:00 am, spray content will spray on the Badges.The badges will apply from 8 to 10 O’clock, 3 shifts per week for one month. Control:It will be exactly the same as the intervention group.Only in the sprays, the refined sweet almond oil Will be placed.
Main outcome variables
stress؛anxiety؛occupational Fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190515043601N1
Registration date: 2019-07-10, 1398/04/19
Registration timing: registered_while_recruiting

Last update: 2019-07-10, 1398/04/19
Update count: 0
Registration date
2019-07-10, 1398/04/19
Registrant information
Name
Hossein Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1427
Email address
hosseinrahimi92@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation aroma with rosemary oils on stress, anxiety and job fatigue in emergency medical technicians
Public title
The effect of inhalation aroma with rosemary oils on stress, anxiety and job fatigue in emergency medical technicians
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
EMS personnel of the Birjand city Non-use of anti-anxiety and anti-depressant drugs-. Do not use perfume during the intervention No drug addiction No history of liver and kidney diseases healthy olfactory
Exclusion criteria:
history of any allergies
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
in order to sampling, firstly, from eight pre-hospital emergency Base of Birjand were selected by available sampling method and according to the entrance criteria, 60 individuals (on average from 7 to 8 personnel from each base) were selected. Bases randomly placed in intervention and control groups by using coin toss.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand university of Medical science
Street address
ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-02-13, 1397/11/24
Ethics committee reference number
IR.BUMS.REC.1397.352

Health conditions studied

1

Description of health condition studied
stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

2

Description of health condition studied
occupational Fatigue
ICD-10 code
ICD-10 code description

3

Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Stress, anxiety, depression,Occupational fatigue
Timepoint
Before, immediately and one month after the intervention
Method of measurement
DASS42 questionnaire,Fatigue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Initially, 25% Rosemary Essence was purchased from tabib daroo Company in Kashan. The intervention group inhaled Rosemary.The intervention group received 5 × 3 cm cotton badges and spray containing 20 ml Rosemary essential oils,the sprays were united and solidified.The badges were placed at a distance of 30 centimeters from the nose,on the uniform of technicians.In the intervention group, 2 puff (one cc) of spray contents were sprayed for one month, three shifts per week and two hours per shift.The researcher reminded using spray during the intervention by telephone and Auto Sms Reminder application.Eventually, immediately and 30 days after the intervention, the questionnaires were completed again.
Category
Treatment - Drugs

2

Description
Control group:Initially, Refined Sweet Almond Oil will purchas from tabib daroo Company in Kashan. The control group inhaled Refined Sweet Almond Oil .Thecontrol group received 5 × 3 cm cotton badges and spray containing 20 ml Refined Sweet Almond Oil ,the sprays were united and solidified.The badges were placed at a distance of 30 centimeters from the nose,on the uniform of technicians.In the control group, 2 puff (one cc) of spray contents were sprayed for one month, three shifts per week and two hours per shift.The researcher reminded using spray during the intervention by telephone and Auto Sms Reminder application.Eventually, immediately and 30 days after the intervention, the questionnaires will complete again.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pre-hospital emergency in Birjand city
Full name of responsible person
mohamad reza hosseini
Street address
ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Email
mohamadrezahoseiniems@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Hossein Dehghani FIroozabadi
Street address
ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Email
drdehghani@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
hossein Rahimi
Position
faculty member of Birjand university of medical science
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Faculty member of Birjand university of medical science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Email
Hosseinrahimi92@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
faculty member of BUMS
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Only available upon request by the BUMS and ethics committee
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
The whole potential data will publish,after being unidentifiable
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data from this research can be used in meta-analyzes and other studies. There is no limit to the use of data.
From where data/document is obtainable
hosseinrahimi92@yahoo.com requesting data is only possible through email queries.
What processes are involved for a request to access data/document
information will be provided in consultation with the Ethics Committee and the Research Deputy of Research at Birjand University of Medical Sciences after receiving the requested information. It may take up to 2 weeks.
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