Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000239864
Ethics application status
Approved
Date submitted
7/01/2020
Date registered
8/03/2021
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Date results provided
8/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
effects of lavender breathing on work stress and job satisfaction in health professionals
Scientific title
examine effects of lavender oil inhalation on work stress and job satisfaction in health professionals.
Secondary ID [1] 300195 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Work stress 315751 0
Condition category
Condition code
Mental Health 314033 314033 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stage 1 (at the beginning of the work shift on Monday): The intervention, placebo and control groups were administered General Characteristics Form, Work Stress Scale and Minnesota Satisfaction Questionnaire .
Stage 2 (from the beginning of the work shift on Monday to the end of the work shift on Friday): The intervention group was asked to breathe deeply three drops of lavender oil put on a diffuser ten times at the beginning of their work shifts every day. Then this diffuser was placed on the participant’s work desks . By this means, the participants breathed the lavander oil aroma spreading withinside the room in which they worked overtime. The placebo group was asked to breathe deeply placebo ten times in a diffuser containing three drops of distilled water added light yellow food dye (since lavender oil is light yellow). Then this diffuser was placed on the participant’s work desks . By this means, the participants breathed the distilled water aroma spreading withinside the room in which they worked overtime. The control group was not exposed to any interventions and continued to perform their daily routine work.
Stage 3 (at the end of the work shift on Friday): The intervention, placebo and control groups were administered General Characteristics Form, Work Stress Scale and Minnesota Satisfaction Questionnaire .
All the participants were told to come to work every day for five days, not to stay out of their room for more than two hours including lunch break and not to ventilate their room.

The primary components of lavender oil used in research are linalool (39%) and linalyl acetate (35%). Other components include limonene, 1,8-cineole, beta-ocimene, 3-octanon cymene, butanoic acid, camphor, beta-caryophyllene, beta-farnesene, borneol. The resulting vapour has fragrance at a level detectable to the average person. Brief descriptions were used to monitor adherence to the intervention.
Intervention code [1] 316471 0
Prevention
Comparator / control treatment
Placebo and control group
The placebo group was asked to inhale placebo ten times in a diffuser containing three drops of distilled water added light yellow food dye (since lavender oil is light yellow). A diffuser was also put on the desks of each participants, which allowed them to inhale the placebo throughout the day. The control group was not exposed to any interventions and continued to perform their daily routine work.
Control group
Placebo

Outcomes
Primary outcome [1] 322441 0
Work stress levels was measured with Work Stress Scale .
Timepoint [1] 322441 0
at the beginning of the work shift on Monday
at the end of the work shift on Friday
Primary outcome [2] 322442 0
Job satisfaction levels was measured with Minnesota Satisfaction Questionnaire
Timepoint [2] 322442 0
at the beginning of the work shift on Monday
at the end of the work shift on Friday
Secondary outcome [1] 378552 0
None
Timepoint [1] 378552 0
None

Eligibility
Key inclusion criteria
working in family healthcare centers (family physicians and other health professionals)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
having a respiratory diseases,
having a hypotension,
having a pregnant,
having a problems with smelling
having an allergy to lavender smell

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/07/2018
Date of last participant enrolment
Anticipated
Actual
29/10/2018
Date of last data collection
Anticipated
Actual
9/11/2018
Sample size
Target
96
Accrual to date
Final
108
Recruitment outside Australia
Country [1] 22206 0
Turkey
State/province [1] 22206 0
Kahramanmaras

Funding & Sponsors
Funding source category [1] 304630 0
University
Name [1] 304630 0
Adnan Menderes University
Country [1] 304630 0
Turkey
Primary sponsor type
University
Name
Adnan Menderes University
Address
Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country
Turkey
Secondary sponsor category [1] 304925 0
Individual
Name [1] 304925 0
Keziban AMANAK
Address [1] 304925 0
Faculty of Health Sciences, Midwifery Department, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country [1] 304925 0
Turkey
Secondary sponsor category [2] 304926 0
Individual
Name [2] 304926 0
Sündüz Özlem Altinkaya
Address [2] 304926 0
Faculty of Health Sciences, Midwifery Department, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country [2] 304926 0
Turkey
Secondary sponsor category [3] 304927 0
Individual
Name [3] 304927 0
Mine Gökduman Keles
Address [3] 304927 0
Faculty of Health Sciences, Midwifery Department, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country [3] 304927 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305050 0
The ethical committee for clinical research of Health Sciences Faculty at Adnan Menderes University
Ethics committee address [1] 305050 0
Ethics committee country [1] 305050 0
Turkey
Date submitted for ethics approval [1] 305050 0
24/05/2018
Approval date [1] 305050 0
30/05/2018
Ethics approval number [1] 305050 0
2018/34

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70326 0
Dr Keziban AMANAK
Address 70326 0
Faculty of Health Sciences, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin.
Country 70326 0
Turkey
Phone 70326 0
+90 256 213 8866
Fax 70326 0
Email 70326 0
[email protected]
Contact person for public queries
Name 70327 0
Keziban Amanak
Address 70327 0
Faculty of Health Sciences, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin
Country 70327 0
Turkey
Phone 70327 0
+90 256 213 8866
Fax 70327 0
Email 70327 0
[email protected]
Contact person for scientific queries
Name 70328 0
Keziban Amanak
Address 70328 0
Faculty of Health Sciences, Adnan Menderes University, Kepez Area, Central Campus, 09100, Aydin
Country 70328 0
Turkey
Phone 70328 0
+90 256 213 8866
Fax 70328 0
Email 70328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.