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Protocol summary
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 three stages (day 0-30-60) their depression is measured.
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 three stages (day 0-30) their depression is measured.
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 three stages (day 0-30-60) their depression is measured.
بیماران مراجعه کننده به کلینیک اعصاب و روان وابسته به دانشگاه علوم پزشکی اراک که اختلال افسردگی آنها بر اساس ملاک های تشخیص DSMVITR و پس از معاینه توسط روانپزشک قطعی شده باشد،به صورت تصادفی دردو گروه قرار میگیرند. و در سه مرحله (روز 0-30-60) افسردگی آن ها سنجیده میشود.
بیماران مراجعه کننده به کلینیک اعصاب و روان وابسته به دانشگاه علوم پزشکی اراک که اختلال افسردگی آنها بر اساس ملاک های تشخیص DSMVITR و پس از معاینه توسط روانپزشک قطعی شده باشد،به صورت تصادفی دردو گروه قرار میگیرند. و در سه مرحله (روز 0-30) افسردگی آن ها سنجیده میشود.
بیماران مراجعه کننده به کلینیک اعصاب و روان وابسته به دانشگاه علوم پزشکی اراک که اختلال افسردگی آنها بر اساس ملاک های تشخیص DSMVITR و پس از معاینه توسط روانپزشک قطعی شده باشد،به صورت تصادفی دردو گروه قرار میگیرند. و در سه مرحله (روز 0-30-60) افسردگی آن ها سنجیده میشود.
Primary outcomes
#1
Before the intervention, after one month, after two months
Before the intervention, after one month,
Before the intervention, after one month, after two months
قبل از شروع مداخله ، بعد از یک ماه ، بعد از دو ماه
قبل از شروع مداخله ، بعد از یک ماه
قبل از شروع مداخله ، بعد از یک ماه ، بعد از دو ماه
Secondary outcomes
#1
Before the intervention, one month after the intervention, two months after the intervention
Before the intervention, one month after the intervention
Before the intervention, one month after the intervention, two months after the intervention
قبل از مداخله ، یک ماه بعد از مداخله ، دو ماه بعد از مداخله
قبل از مداخله ، یک ماه بعد از مداخله
قبل از مداخله ، یک ماه بعد از مداخله ، دو ماه بعد از مداخله
Intervention groups
#1
Intervention group: The intervention group is taught to perform aromatherapy for two months, 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 and 60 days after the intervention
Intervention group: The intervention group is taught to perform aromatherapy for two months, 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
Intervention group: The intervention group is taught to perform aromatherapy for two months, 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 and 60 days after the intervention
گروه مداخله: به گروه مداخله آموزش داده می شود که رایحه درمانی را به مدت دو ماه انجام دهند به این ترتیب که 2 قطره از اسانس گل رز 2% محصول شرکت باریج اسانس با قطره چکان بر روی گاز 10 × 10 سانتی متر ریخته و آن را به فاصله 20 سانتی متری بینی آزمودنی ها و برروی پیراهن آن ها متصل می شود و بیماران آن را به مدت 20 دقیقه استنشاق می کنند. این کار را روزانه دوبار انجام می دهند. میزان بهبودی افسردگی بر اساس پرسشنامه بک در 30 و 60 روز بعد از مداخله ارزیابی خواهد شد
گروه مداخله: به گروه مداخله آموزش داده می شود که رایحه درمانی را به مدت دو ماه انجام دهند به این ترتیب که 2 قطره از اسانس گل رز 2% محصول شرکت باریج اسانس با قطره چکان بر روی گاز 10 × 10 سانتی متر ریخته و آن را به فاصله 20 سانتی متری بینی آزمودنی ها و برروی پیراهن آن ها متصل می شود و بیماران آن را به مدت 20 دقیقه استنشاق می کنند. این کار را روزانه دوبار انجام می دهند. میزان بهبودی افسردگی بر اساس پرسشنامه بک در 30 روز بعد از مداخله ارزیابی خواهد شد
گروه مداخله: به گروه مداخله آموزش داده می شود که رایحه درمانی را به مدت دو ماه انجام دهند به این ترتیب که 2 قطره از اسانس گل رز 2% محصول شرکت باریج اسانس با قطره چکان بر روی گاز 10 × 10 سانتی متر ریخته و آن را به فاصله 20 سانتی متری بینی آزمودنی ها و برروی پیراهن آن ها متصل می شود و بیماران آن را به مدت 20 دقیقه استنشاق می کنند. این کار را روزانه دوبار انجام می دهند. میزان بهبودی افسردگی بر اساس پرسشنامه بک در 30 و 60 روز بعد از مداخله ارزیابی خواهد شد
#2
Control group: The control group is taught to perform aromatherapy for two months, 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 and 60 days after the intervention
Control group: The control group is taught to perform aromatherapy for two months, 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
Control group: The control group is taught to perform aromatherapy for two months, 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 and 60 daysday after the intervention
گروه کنترل: به گروه کنترل آموزش داده می شود که رایحه درمانی را به مدت دو ماه انجام دهند به این ترتیب که 2 قطره از آب مقطر رز 2% محصول شرکت باریج اسانس با قطره چکان بر روی گاز 10 × 10 سانتی متر ریخته و آن را به فاصله 20 سانتی متری بینی آزمودنی ها و برروی پیراهن آن ها متصل می شود و بیماران آن را به مدت 20 دقیقه استنشاق می کنند. این کار را روزانه دوبار انجام می دهند. میزان بهبودی افسردگی بر اساس پرسشنامه بک در 30 و 60 روز بعد از مداخله ارزیابی خواهد شد
گروه کنترل: به گروه کنترل آموزش داده می شود که رایحه درمانی را به مدت دو ماه انجام دهند به این ترتیب که 2 قطره از آب مقطر رز 2% محصول شرکت باریج اسانس با قطره چکان بر روی گاز 10 × 10 سانتی متر ریخته و آن را به فاصله 20 سانتی متری بینی آزمودنی ها و برروی پیراهن آن ها متصل می شود و بیماران آن را به مدت 20 دقیقه استنشاق می کنند. این کار را روزانه دوبار انجام می دهند. میزان بهبودی افسردگی بر اساس پرسشنامه بک در30 روز بعد از مداخله ارزیابی خواهد شد
گروه کنترل: به گروه کنترل آموزش داده می شود که رایحه درمانی را به مدت دو ماه انجام دهند به این ترتیب که 2 قطره از آب مقطر رز 2% محصول شرکت باریج اسانس با قطره چکان بر روی گاز 10 × 10 سانتی متر ریخته و آن را به فاصله 20 سانتی متری بینی آزمودنی ها و برروی پیراهن آن ها متصل می شود و بیماران آن را به مدت 20 دقیقه استنشاق می کنند. این کار را روزانه دوبار انجام می دهند. میزان بهبودی افسردگی بر اساس پرسشنامه بک در 30 و 60در30 روز بعد از مداخله ارزیابی خواهد شد
Recruitment centers
#1
Name of recruitment center - English: درمانگاه های اعصاب و روان دانشگاه علوم پزشکی اراک
Name of recruitment center - Persian: Neuropsychological clinics of Arak University of Medical Sciences
Full name of responsible person - English: علی جدیدی
Full name of responsible person - Persian: Ali jadidi
Street address - English: Faculty of Nursing and Midwifery.Basij Square.Taleghani Street.Arak
Street address - Persian: اراک، خیابان طالقانی، میدان بسیج، دانشکده پرستاری و مامایی.
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3813944438
Phone: +98 86 3417 3524
Fax:
Email: jadidi@arakmu.ac.ir
Web page address:
Name of recruitment center - English: Neuropsychological clinics of Arak University of Medical Sciences
Name of recruitment center - Persian: درمانگاه های اعصاب و روان دانشگاه علوم پزشکی اراک
Full name of responsible person - English: Ali jadidi
Full name of responsible person - Persian: علی جدیدی
Street address - English: Faculty of Nursing and Midwifery.Basij Square.Taleghani Street.Arak
Street address - Persian: اراک، خیابان طالقانی، میدان بسیج، دانشکده پرستاری و مامایی.
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3813944438
Phone: +98 86 3417 3524
Fax:
Email: jadidi@arakmu.ac.ir
Web page address:
Name of recruitment center - English: Neuropsychological clinics of Arak University of Medical Sciences Name of recruitment center - Persian: درمانگاه های اعصاب و روان دانشگاه علوم پزشکی اراک Name of recruitment center - Persian: Neuropsychological clinics of Arak University of Medical Sciences Full name of responsible person - English: علی جدیدیAli jadidi Full name of responsible person - Persian: Ali jadidiعلی جدیدی Street address - English: Faculty of Nursing and Midwifery.Basij Square.Taleghani Street.Arak Street address - Persian: اراک، خیابان طالقانی، میدان بسیج، دانشکده پرستاری و مامایی. City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3813944438 Phone: +98 86 3417 3524 Fax: Email: jadidi@arakmu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: علی جدیدی
Full name of responsible person - Persian: Ali jadidi
Street address - English: Arak University of Medical Sciences.Alam El Hadi Stret
Street address - Persian: خیابان علم الهدی، دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3813944438
Phone: +98 86 3417 3524
Fax:
Email: jadidi@arakmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali jadidi
Full name of responsible person - Persian: علی جدیدی
Street address - English: Arak University of Medical Sciences.Alam El Hadi Stret
Street address - Persian: خیابان علم الهدی، دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 3813944438
Phone: +98 86 3417 3524
Fax:
Email: jadidi@arakmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: علی جدیدیAli jadidi Full name of responsible person - Persian: Ali jadidiعلی جدیدی Street address - English: Arak University of Medical Sciences.Alam El Hadi Stret Street address - Persian: خیابان علم الهدی، دانشگاه علوم پزشکی اراک City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 3813944438 Phone: +98 86 3417 3524 Fax: Email: jadidi@arakmu.ac.ir Web page address:
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 three 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 two months, 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
Acronym
IRCT registration information
IRCT registration number:IRCT20220703055351N2
Registration date:2023-04-21, 1402/02/01
Registration timing:prospective
Last update:2023-05-01, 1402/02/11
Update count:2
Registration date
2023-04-21, 1402/02/01
Registrant information
Name
Mahsa Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 1221 9498
Email address
smahsahosseini99@gmail.com
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
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)
Single 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3813944438
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 two months, 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 two months, 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
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuropsychological clinics of Arak University of Medical Sciences
Full name of responsible person
Ali jadidi
Street address
Faculty of Nursing and Midwifery.Basij Square.Taleghani Street.Arak
City
Arak
Province
Markazi
Postal code
3813944438
Phone
+98 86 3417 3524
Email
jadidi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali jadidi
Street address
Arak University of Medical Sciences.Alam El Hadi Stret
City
Arak
Province
Markazi
Postal code
3813944438
Phone
+98 86 3417 3524
Email
jadidi@arakmu.ac.ir
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
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali jadidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery. Basij Square.Taleghani Street.Arak
City
Arak
Province
Markazi
Postal code
3813944438
Phone
+98 86 3417 3524
Email
jadidi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali jadidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery.Basij Square,Taleghani Street.Arak
City
Arak
Province
Markazi
Postal code
3813944438
Phone
+98 86 3417 3524
Email
jadidi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahsa Hosseini
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery.Basij Square.Taleghani Street.Arak
City
Arak
Province
Markazi
Postal code
3813944438
Phone
009832218498
Email
mahsahoseiny2018@gmail.com
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