Protocol summary
-
Study aim
-
So far, no specific complications have been observed in connection with the use of rose essential oil. Similarly, this drug has been used to reduce the symptoms of depression in animal models (21), but it has not been used to reduce the symptoms of depression in patients. Therefore, this study will be conducted with the aim of investigating the effect of rose essential oil on reducing depression symptoms in patients referred to the clinics of Arak University of Medical Sciences.
-
Design
-
This research is a double-blind randomized clinical trial with a parallel control group, which will use a coin toss for randomization
-
Settings and conduct
-
Patients referred to the neuropsychiatric clinic affiliated to Arak University of Medical Sciences, whose depression disorder has been determined based on DSMVITR diagnostic criteria and after examination by a psychiatrist, are randomly assigned to two groups. And in two stages (day 0-30) their depression is measured.
-
Participants/Inclusion and exclusion criteria
-
Age 18-70 years
Not having a psychotic phase
Absence of suicidal thoughts
No history of mental disorder
Not taking antidepressants
Absence of olfactory disorders
No history of allergy and eczema to rose
Being able to understand and write Persian language
-
Intervention groups
-
The people of the control and intervention groups are taught to perform aromatherapy for one month, in this way, 2 drops of 2% rose essence produced by Barij Essence Company for the intervention group and the same amount of distilled water for the control group, with The dropper is poured on a 10 x 10 cm gas and it is connected to a distance of 20 cm from the subject's nose and on their shirt, and the patients inhale it for 20 minutes. They do this twice a day. The recovery rate will be evaluated after the intervention
-
Main outcome variables
-
Depression, age, sex, marriage, education, job
General information
-
Reason for update
-
The request to update this protocol has various reasons, one of the most important of which is the disruption in sampling, which means that due to the long duration of the entire intervention, many participants did not finish the intervention at the beginning, and for this reason, the authors, citing Previous studies based on shorter intervention length (one month duration) decided to sample for the second time and with shorter intervention length. Therefore, please update the changes included in the method. The protocols with one month intervention and almost similar to the present study:
IRCTID: IRCT20190305042936N1
IRCTID: IRCT20230702058649N1
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20220703055351N2
Registration date:
2023-04-21, 1402/02/01
Registration timing:
prospective
Last update:
2024-12-09, 1403/09/19
Update count:
2
-
Registration date
-
2023-04-21, 1402/02/01
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2023-05-22, 1402/03/01
-
Expected recruitment end date
-
2024-01-21, 1402/11/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Investigating the effect of aromatherapy with rose essential oil on depression in patients referred to neurology clinics
-
Public title
-
Investigating the effect of aromatherapy with rose essential oil on depression in patients referred to neurology clinics
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age 18-70 years, no psychotic phase, no suicidal thoughts, no history of mental disorders, no use of antidepressants, no olfactory disorders, no history of rose allergy and eczema, able to understand and write Persian language.
Exclusion criteria:
Pregnancy, postpartum depression, reluctance to continue studying, olfactory disorders and complications caused by essential oil consumption, allergies
-
Age
-
From 18 years old to 70 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
80
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
In this research, coin tossing will be used for randomization. In this way, the first participant is placed randomly (coin toss) in one of the two intervention or control groups. In the next step, the participants will be distributed evenly between the two groups. In such a way that if the line comes for the first time and the researcher considers the line to be the entry into the control group, the subjects will be entered into the intervention group first and then the control group according to the order of entry into the study
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Blinding in this study will be double blind. In order to reduce the error and bias in this clinical study, the intervention and control group (participants) will be blinded to the type of intervention using a placebo. Also, the plan executives are not included in the process of intervention by conducting the intervention by a researcher other than the people who prepare the draft of the article.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2023-04-19, 1402/01/30
-
Ethics committee reference number
-
IR.ARAKMU.REC.1402.021
Health conditions studied
1
-
Description of health condition studied
-
Patients with depression
-
ICD-10 code
-
F33.0
-
ICD-10 code description
-
Major depressive disorder, recurrent, mild
Primary outcomes
1
-
Description
-
depression
-
Timepoint
-
Before the intervention, after one month,
-
Method of measurement
-
"Beck Depression Questionnaire"
Secondary outcomes
1
-
Description
-
Age, gender, marital status, occupation
-
Timepoint
-
Before the intervention, one month after the intervention
-
Method of measurement
-
Ask people
Intervention groups
1
-
Description
-
Intervention group: The intervention group is taught to perform aromatherapy for one month, in this way that 2 drops of 2% rose essential oil, a product of Barij Essential Oil Company, is poured with a dropper on a 10 x 10 cm gas. It is connected to a distance of 20 cm from the subject's nose and on their shirt, and the patients inhale it for 20 minutes. They do this twice a day. The recovery rate of depression will be evaluated based on the Beck questionnaire in 30 days after the intervention
-
Category
-
Treatment - Other
2
-
Description
-
Control group: The control group is taught to perform aromatherapy for one month, in this way, by pouring 2 drops of 2% rose water distilled from Barij Essense Company with a dropper on a 10 x 10 cm gas. It is connected to a distance of 20 cm from the subject's nose and on their shirt, and the patients inhale it for 20 minutes. They do this twice a day. The recovery rate of depression will be evaluated based on the Beck questionnaire in 30 day after the intervention
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Arak 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
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
-
There is no further information."
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Not applicable
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable