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The effect of rose water aromatherapy on stress, anxiety, depression and Compassion Fatigue in Babol pre hospital emergency organization staffs

Protocol summary

Study aim
Determining the effect of aromatherapy with rose water on stress, anxiety, depression and compassion-induced fatigue in pre hospital emergency personnel
Design
A control trial with a control group, with parallel, randomized, phase three groups on 70 pre-hospital staff, will use coin toss to randomize pre-hospital bases.
Settings and conduct
The researcher referred to the Babol Pre-Hospital Emergency Organization and the samples will be selected according to the inclusion criteria. Demographic, questionnaire, anxiety and depression questionnaires will complement compassion fatigue. In the experimental group, 5 drops of rose essential oil (Kashan Barich Essential Oil Company) and in the placebo group, 5 drops of distilled water are poured on the palms of the personnel. They are then asked to place their hands in front of their noses and take ten deep breaths in two minutes. This will be done in three shifts over the course of a week. After one week of intervention, the above questionnaires will be completed again by both groups.
Participants/Inclusion and exclusion criteria
At least one year of experience in pre -hospital work, no olfactory dysfunction based on self-reported personnel, no history of asthma, allergies and chronic diseases, no stressful events in the last three months based on self-reported personnel, no use of Sedatives and narcotics
Intervention groups
In the experimental group, 5 drops of rose essential oil (Kashan Barich Essential Oil Company) and in the placebo group, 5 drops of distilled water are poured on the palms of pre-hospital emergency personnel. They are then asked to place their hands in front of their noses and take ten deep breaths in two minutes. This will be done in three shifts over the course of a week.
Main outcome variables
Determining the level of stress, anxiety, depression in pre-hospital staff

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042617N3
Registration date: 2021-09-02, 1400/06/11
Registration timing: prospective

Last update: 2021-09-02, 1400/06/11
Update count: 0
Registration date
2021-09-02, 1400/06/11
Registrant information
Name
Parvin ََAziznejadroshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0597
Email address
aziznejadroshan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rose water aromatherapy on stress, anxiety, depression and Compassion Fatigue in Babol pre hospital emergency organization staffs
Public title
The effect of rose water aromatherapy on stress, anxiety, depression and Compassion Fatigue in pre hospital emergency organization staffs
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have one year of experience in pre -hospital emergency
Exclusion criteria:
Having a history of asthma, allergies and chronic diseases Stressful events such as divorce and the death of loved ones for any reason in the past three months Existence of olfactory disorder based on staff self-declaration Use of benzodiazepines, sedatives and narcotics
Age
From 23 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
There are fourteen pre-hospital emergency bases (road and city) affiliated to Babol University of Medical Sciences in Babol city. First, twelve bases are randomly selected and then randomly divided into two groups of intervention and control based on coin toss, and their members are entered into the study as a sample.
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2021-08-08, 1400/05/17
Ethics committee reference number
IR. MUBABOL. REC .1400. 014

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
P91.4
ICD-10 code description
Neonatal cerebral depression

2

Description of health condition studied
Stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

3

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

4

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

Primary outcomes

1

Description
Stress score on Depression, Anxiety, Stress Scale - 21 (DASS -21)
Timepoint
At the beginning of the study and one week after starting aromatherapy with rose
Method of measurement
DASS-21 questionnaire

2

Description
Anxiety score on DASS-21
Timepoint
At the beginning of the study and one week after starting aromatherapy with rose
Method of measurement
DASS-21 questionnaire

3

Description
Depression score on DASS-21
Timepoint
At the beginning of the study and one week after starting aromatherapy with rose
Method of measurement
DASS-21 questionnaire

Secondary outcomes

1

Description
Compassion fatigue score
Timepoint
At the beginning of the study and one week after starting aromatherapy with rose
Method of measurement
Figley Compassion Fatigue Questionnaire

Intervention groups

1

Description
Intervention group: 5 drops of rose essential oil (from Barich Essential Oil Company of Kashan) are poured on the palms of pre-hospital emergency personnel and they are asked to hold their hands in front of their noses and take ten deep breaths in two minutes. This will be done in three shifts over the course of a week
Category
Prevention

2

Description
Control group: 5 drops of distilled water are poured on the palms of pre-hospital emergency personnel and they are asked to hold their hands in front of their noses and take ten deep breaths in two minutes. This will be done in three shifts over the course of a week.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol Pre-Hospital Emergency Organization
Full name of responsible person
Dr. Abolghasem laali
Street address
Pre-Hospital Emergency Organization، University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3220 0901
Email
edwin.laali@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
ِDr. Reza Ghadimi
Street address
Gangafros
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Web page address
http://research.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Parvin Aziznejadroshan
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gangafros
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0597
Email
aziznejadroshan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parvin Aziznejadroshan
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gangafros
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 2597
Email
aziznejadroshan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parvin Aziznejadroshan
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gangafros
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0597
Email
aziznejadroshan@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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