Protocol summary

Study aim
The Effect of Aromatherapy with the Essential Oil of Granium on Premenstrual Syndrome in Students of Gonabad University of Medical Sciences
Design
This trial has two parallel groups, including the geranium essential oil group and the placebo group. The sample size estimated for this study is 60 people who will be divided randomly into two groups by simple random sampling.
Settings and conduct
This study will be conducted blindly in Gonabad University of Medical Sciences. In this study, researchers are unaware of the allocation of individuals to the geranium essential oils and placebo. Data collection is also based on a demographic information form, a screening tool for symptoms before Menstruation and General Health Questionnaire
Participants/Inclusion and exclusion criteria
Desire to participate in the plan, non-use of vitamin supplements, non-use of hormonal drugs at least 2 months ago, menstrual periods between 24 and 35 days, lack of underlying illness such as diabetes, thyroid disorders, or any mental disorder, business Scores higher than 20 from the screening questionnaire for premenstrual symptoms, gaining score less than 23 from the general health questionnaire, entry criteria Unwillingness to cooperate, stressful events during the cycle and intervention, changes in the menstrual cycle that reduce the period to less than 24 days or increase to over 35 days, changes in the menstrual cycle leading to Reduce the number of bleeding days to less than 3 days or increase it to more than 7 days. Occurrence such as marriage, surgery, at least 3 months before the start of the study, sensitivity to the essential oil of the herb, exit criteria
Intervention groups
In the intervention group, the essential oil of the geranium plant with a concentration of 0.5% will be used. In the control group, the drug (sweet almond oil) will be used
Main outcome variables
of Granium on Premenstrual Syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181029041495N2
Registration date: 2019-03-18, 1397/12/27
Registration timing: retrospective

Last update: 2019-03-18, 1397/12/27
Update count: 0
Registration date
2019-03-18, 1397/12/27
Registrant information
Name
Mohsen Aliakbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5733 2028
Email address
aliakbari.m.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-08, 1397/07/16
Expected recruitment end date
2019-01-14, 1397/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Aromatherapy with the Essential Oil of Geranium on Premenstrual Syndrome in Students of Gonabad University of Medical Sciences
Public title
The effect of geranium essential oil on premenstrual syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the plan Not using vitamin supplements No use of hormonal medications at least 2 months ago The length of the menstrual period is between 24 and 35 days Lack of underlying disease, such as diabetes, thyroid gland disorders, or any mental disorder Earning score above 20 from the screening questionnaire for symptoms of premenstrual syndrome Earn less than 23 points from the General Health Questionnaire
Exclusion criteria:
Unwillingness to cooperate Occurrence of stressful events during the cycle and intervention Changes in the menstrual cycle that result in a decrease in the duration of the period to less than 24 days or increase to more than 35 days. Changes in the menstrual cycle that lead to a reduction in the number of bleeding days to less than 3 days or an increase of more than 7 days. Occurrence such as marriage, surgery, at least 3 months before the start of the study Sensitivity to essential oil of geranium
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the method of permutation blocks (30 blocks, dual) was used. For this purpose, the letter A represents the group of geranium and letter B, representing the control group, and there were two possible cases of AB and BA. Then the contract is closed if, in the random numbers table, the number of pairs is replaced by AB, and if the number is the case, the BA substitution of the patients in the groups is performed. In this case, if in the random numbers table, the number of paired numbers entering the study was placed in the geranium group and the next person was placed in the control group. In the random numbers table, if the odd number came from the BA permutation block, that is, the first patient in the control group and the second patient in the geranium group. All numbers were randomly selected using random numbers. It should be noted that the direction and direction of movement in the random numbers table were determined in advance. This work continued until the determination of 30 double blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the blinding of samples and researchers, the essential oils are presented in a dish of the same color and shape. For intervention, twice a day, 10 drops of essential oil are poured onto cotton and pinched with a pin at a distance of 30 cm from the nose, and the subject will breathe in for a period of 5 minutes with ordinary breathing.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad,Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-02-12, 1397/11/23
Ethics committee reference number
IR.GMU.REC.1397.099

Health conditions studied

1

Description of health condition studied
Granium on Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Granium on Premenstrual Syndrome
Timepoint
Before and after two consecutive menstrual cycles
Method of measurement
Demographic data form, Premenstrual symptoms screening tool and General Health Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In order to interfere with the essential oil of the geranium herb with a concentration of 0.05% from Barij Essen. Each person will be given 5 ml of essential oil for one month. Twice a day, 10 drops of essential oil will be poured on cotton and pinched with a pin at a distance of 30 cm from the nose, and will inhale the fragrances every 5 minutes with ordinary breathing.
Category
Prevention

2

Description
Control group: In order to interfere with the sweet odorless sweet almond oil from Barís Essence, the company bought. Each person will be given 5 ml of almond oil for one month. Twice a day, 10 drops of oil will be poured on cotton and pinched with a pin at a distance of 30 cm from the nose, and will breathe the personally breathable scent every 5 minutes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fajr University of Medical Sciences Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Gholamian
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 3028
Email
gholamian1998@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Sajjadi
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Sajjadi.sal@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Ggholamian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
gholamian1998@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences,Asian Roads,Gonabad,Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeh@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohsen Aliakbari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads,Gonabad,Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
mohsenaliakbari1998@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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