The effect of aromatherapy with sour lemon essential oil on the level of occupational stress and occupational fatigue among operating room technologists
The effect of aromatherapy with sour lemon essential oil on the level of occupational stress and occupational fatigue among operating room technologists
Design
A double-blind randomized clinical trial with two control and experimental groups.
The control group smell placebo and the experimental group smell lemon essential oil.
The sample size is 206 people, including 103 people in the test group and 103 people in the control group.
At first, the hospitals will be randomly placed in two test and control groups using the tap or line method, and then a target-based easy sampling will be done as a quota among the target hospitals in Isfahan city.
Settings and conduct
Aromatherapy with lemon essential oil in the experimental group and the use of placebo in the control group.Aromatherapy at the beginning of technologists' shift for half an hour in three consecutive shifts in selected hospitals in Isfahan.Double-blind researcher and data analyst
Participants/Inclusion and exclusion criteria
Operating room technologists with consent
Intervention groups
Aromatherapy will be in the the beginning of the technologists' shift. The experimental group will be taught to pour four drops of lemon essential oil made by Barij Essential Oil Company on 5:5 medical gas and put it inside their mask for half an hour.the control group will be taught to pour four drops of distilled water on the gas and place it inside their mask for half an hour. Duration of aromatherapy will be in three consecutive morning shifts in one week for 30 minutes. Questionnaires will be completed by two groups before aromatherapy, after the last aromatherapy and ten days and seventeen days after the last aromatherapy.
Main outcome variables
The results of this study will show whether aromatherapy with lemon has an effect on occupational stress and fatigue of operating room technologists or not.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240624062247N1
Registration date:2024-08-10, 1403/05/20
Registration timing:registered_while_recruiting
Last update:2024-08-10, 1403/05/20
Update count:0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Soheila Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 7153
Email address
bakhtiari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-09-10, 1403/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with sour lemon essential oil on the level of occupational stress and occupational fatigue among operating room technologists
Public title
effect of aromatherapy with sour lemon essential oil on the level of occupational stress and occupational fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a history of olfactory disorders based on self-report
Not taking sedative or anti-anxiety drugs based on self-report
Not having a history of allergy to the smell of plants based on self-report
Not having a history of migraine and chronic headaches based on self-report
Not having a history of anxiety disorders based on self-report
The absence of an unfortunate incident within a month before the intervention
Not having liver and kidney problems
Not using cigarettes, alcohol and drugs
Not using perfume or cologne by the person during the intervention days
Exclusion criteria:
1. Unwillingness to cooperate
2. History of sensitivity to scent
3. Disturbance in the sense of smell
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
206
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the hospitals will be randomly placed in two test and control groups using the tap or line method, and then a target-based easy sampling will be done as a quota among the target hospitals in Isfahan city.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is not aware of the contents of the aromatherapy bottles that are prepared by the second research associate. Non-transparent sealed envelopes (A, B envelopes) are prepared by the second research associate.
The data analyst is unaware of the relevance of the data to the test and control group
Placebo
Used
Assignment
Parallel
Other design features
The study includes two control and experimental groups. The experimental group smelled lemon essential oil and the control group smelled placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Medicine - Isfahan University of Medical Sciences
Street address
Building No. 4,Research and Technology Vice-Chancellor ., Isfahan University of Medical Sciences and Health Care Services,Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.MUI.MED.REC.1403.118
Health conditions studied
1
Description of health condition studied
the effect of lemon essential oil on occupational stress
ICD-10 code
Z56.3
ICD-10 code description
Stressful work schedule
2
Description of health condition studied
the effect of lemon essential oil on occupational fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
Primary outcomes
1
Description
The average job stress score in Gary Taft and Anderson's Nursing Stress Questionnaire
Timepoint
before the start of the study and three days after the intervention and ten days and seventeen days after the intervention
Method of measurement
Gerry-Taft and Anderson job stress questionnaire
Secondary outcomes
1
Description
The average score of occupational fatigue in the recovery questionnaire of occupational fatigue/excessive fatigue
Timepoint
before the study and three days, ten days and seventeen days after performing aromatherapy with lemon essential oil
Method of measurement
Occupational Fatigue/ Exhaustion Recovery Scale
Intervention groups
1
Description
Intervention group: The use of lemon essential oil is 2%, which is produced by Barij Essential Oil Company. This essential oil is poured on medical gas and placed inside the mask, and it is inhaled by operating room technologists in three consecutive shifts in one week, each time for 30 minutes.
Category
Rehabilitation
2
Description
Control group: The use of distilled water as a placebo, which is poured on medical gas and placed inside the mask, is inhaled by operating room technologists in three consecutive shifts in one week, each time for 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Zahra Shirani
Street address
Al-Zahra Hospital,Soffeh Boulevard.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 0000
Email
dean@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
Building No. 4,Research and Technology Vice-Chancellor ., Isfahan University of Medical Sciences and Health Care Services,Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research and Technology Center of Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Soheila Bakhtiari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Operation room
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
bakhtiari@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Soheila Bakhtiari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Operation room
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
bakhtiari@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Soheila Bakhtiari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Operation room
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
bakhtiari@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 1 month after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use in alignment research
From where data/document is obtainable
Dr Soheila Bakhtiari
bakhtiari@nm.mui.ac.ir
What processes are involved for a request to access data/document
Coordinating with the project manager and explaining the reasons for the need for data