Evaluation of the effect of rose essential oil and its comparison with the effect of lemongrass tea on reducing stress and depression in gynecology assistants
Comparing the level of anxiety and stress of gynecology assistants in two groups of inhaling rose essential oil and drinking lemongrass tea.
Design
Clinical trial, with parallel groups and crossover, unblinded, randomized, phase 3 on 40 subjects. Block randomization was used for randomization.
Settings and conduct
Obstetrics and Gynecology Assistants of Mahdieh Hospital in Tehran will participate in this project and will be randomly divided into two groups by random block method. The study will be cross-over.This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Obstetrics and Gynecology assistants
Exclusion criteria: Major anxiety disorder ,hypothyroidism
Intervention groups
group 1: is exposed to inhaling rose essential oil (Ide Daru Pars Company) for one minute a day for two weeks.
group 2: consumes lemon balm tea (Golkooh company) in the morning and in the evening for two weeks.
After two-week break, the intervention groups will receive type of treatment that they did not receive in the first phase.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220821055767N1
Registration date:2023-09-24, 1402/07/02
Registration timing:retrospective
Last update:2023-09-24, 1402/07/02
Update count:0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Somaye Fatali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
somayeh_fathali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of rose essential oil and its comparison with the effect of lemongrass tea on reducing stress and depression in gynecology assistants
Public title
Comparing the effects of rose and lemongrass in reducing stress and depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
gynecology assistants
Exclusion criteria:
Hypothyroidism
Major anxiety disorder
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Each person will consume one time of rose essential oil and one time of lemongrass tea while observing the washing period.
Randomization (investigator's opinion)
Randomized
Randomization description
The classification of the samples to the treatment groups will be done in a block randomization. The randomization unit is considered individual.
RAS statistical software (Random Allocation Software), the block randomization tool will also be used to determine the sequence of blocks. The size of the blocks is 4.The sealed enveloper will be used for allocation concealment. In the RAS software, we enter the size of the blocks along with the number of groups and the total sample size. Then, the software will provide us random blocks among all possible permutations of the same block size. The people who enter the study are assigned to two groups A and B based on these selection blocks. When all subjects are included in the study, we randomly assign indices B and A to one of the treatment groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee at the Shahid Beheshti University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, 5th Floor, Sanad Building, Shahid Beheshti University, next to the Taleghani Hospital, Shahid Abbas Arabi St. (Parvaneh), Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.228
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F06.32
ICD-10 code description
Mood disorder due to known physiological condition with major depressive-like episode
Primary outcomes
1
Description
depression
Timepoint
Before starting the intervention and 2 weeks later, after completing the intervention
Method of measurement
Beck depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: For two weeks, a person inhales 5 drops of Rose essential oil (Produced by Ide Daru Pars Company. Each 100 ml of product contains 2 ml of natural rose essence.) for one minute once a day. Then two weeks rest is given. In the next stage, people drink 1.5 grams of Golkooh lemon balm tea twice a day for two weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: For two weeks, twice a day, 1.5 grams of lemon balm (tea bags from Golkooh Company) are brewed for 5 minutes and consumed. Then two weeks rest is given. In the next stage, for two weeks, a person inhales 5 drops of Rose essential oil (Produced by Ide Daru Pars Company. Each 100 ml of product contains 2 ml of natural rose essence.) for one minute once a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Atefeh Moridi
Street address
Mahdieh Hospital, Shishehgar Khaneh St., Fadayian Islam Blvd., Shush Square
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdieh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Next to Ayatollah Taleghani Hospital, Arabi Ave, Daneshjoo Blvd, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Fatali
Position
physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mahdieh Hospital, Shishehgarkhaneh St , Fedayian Islam Blvd., Shush Square
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
+98 21 5506 2627
Email
somayeh_fathali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somaye Fatali
Position
Physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mahdieh Hospital, Shishehgar Khaneh St., Fadayian Islam Blvd., Shush Square
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
somayeh_fathali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somaye Fatali
Position
Physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mahdieh Hospital, Shishehgar Khaneh St., Fadayian Islam Blvd., Shush Square
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
somayeh_fathali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The questionnaires that the participants complete can be presented at the end of the study.
When the data will become available and for how long
After the completion of the project and 3 months after the publication of the results
To whom data/document is available
This information will be accessible to health researchers.
Under which criteria data/document could be used
The data can be reviewed to help conduct further studies or to summarize existing studies in this field.
From where data/document is obtainable
Office of vice-president for research at the Mahdieh Hospital
What processes are involved for a request to access data/document
First step, a written request must be made to the vice-president for research at hospital. If approved, the documents will be provided to the requester.