Comparison of the Effect of Melissa Officinalis Capsules and Health Care Educational Program on the Severity of the Symptoms of Premenstrual Syndrome in High School Girl Students in Shiraz
This is a randomized clinical controlled trial. Goal of study: to evaluate the effect of Melissa officinalis capsules and health care educational program on the severity of the symptoms of premenstrual syndrome of 200 girl students selected from 5 high schools of Shiraz. After obtaining informed consent, the students, who meet inclusion criteria, are randomly assigned to four groups (two experimental groups and two control groups). The first experimental group receives herbal capsules and the second experimental group attends health care educational program.Since the researcher supervise the performance of the participants of the control group, they are not allowed to take other medications during the intervention period. The participants in the first experimental group receive the medication for a 3-month period (they take 2 capsules daily for 3 months) and those in the second experimental group attend an educational program consisted of six two-hour educational sessions. Data are collected using General Health Questionnaire, awareness and insight and Premenstrual Syndrome Screening Questionnaire. The questionnaires are completed by the participants of experimental groups before, immediately after and every month after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060717998N1
Registration date:2014-08-16, 1393/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-16, 1393/05/25
Registrant information
Name
Mansoreh Dehghani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 718219532
Email address
dehghani-ma@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Expected recruitment start date
2004-01-21, 1382/11/01
Expected recruitment end date
2014-08-06, 1393/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Melissa Officinalis Capsules and Health Care Educational Program on the Severity of the Symptoms of Premenstrual Syndrome in High School Girl Students in Shiraz
Public title
The Effect of Melissa Officinalis Capsules and Health Care Educational Program on the Severity of the Symptoms of Premenstrual Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study, obtaining informed consent from the parents of the students, not being in any stressful situation at the time of enrollment or during the study, presence in the educational sessions, not consuming vitamin supplements at the time of enrollment, not consuming hormonal medications such as contraceptives for at least 2 months before or during the study, a menstrual period of 3 to 7 days, lack of any underlying diseases such as thyroid diseases, diabetes mellitus and psychiatric disease. Exclusion criteria: the children’s willingness to leave the study, the request of the parents for exclusion of their children from the study, occurrence of a stressful event for the students or their parents during the study, absence of more than 2 sessions in group interactions and not compensating for missed sessions by participating in the sessions of other groups, consuming any medications during the study, any changes in the menstrual period (less than 3 days and more than 7 days), any changes in menstrual cycle length (less than 24 days and more than 35 days) and having stress during the study or in the last 3 months (such as death of the relatives, marriage or undergoing any surgical procedure).
Age
From 76 years old to 72 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
800
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences Shiraz, Zand Blvd.
City
Shiraz
Postal code
7193613119
Approval date
2013-12-16, 1392/09/25
Ethics committee reference number
CT-92-335154
Health conditions studied
1
Description of health condition studied
Premensstural Syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Mental and emotional symptoms of premenstrual syndrome
Timepoint
In the second step before the intervention and at the end of each month after the intervention (for 3 months)
Method of measurement
Premenstrual Syndrome Screening Questionnaire
2
Description
Physical symptoms of premenstrual syndrome
Timepoint
In the second step before the intervention and at the end of each month after the intervention (for 3 months
Method of measurement
Premenstrual Syndrome Screening Questionnaire
Secondary outcomes
1
Description
Individual's general health especially mental health
Timepoint
Before the intervention
Method of measurement
General Health Questionnaire (G.H.Q)
Intervention groups
1
Description
In the control group who receive placebo: The participants take a dosage of 1200 mg per day taken as 2 capsules of 600 mg from the first day of the menstrual cycle for 3 cycles. Researcher calls the research unit at least 3 to 4 times and talks to them call them for guidance. Capsules are given to the students monthly. The participants complete the questionnaires at the end of each month.
Category
Placebo
2
Description
In the experimental group who attend health care educational program: The participants attend an educational program consisted of six two-hour educational sessions. The students complete the awareness and insight questionnaire once at the beginning of the program and once at the end of the 6th session.
Category
Prevention
3
Description
In the control group of the educational program: The participants only complete the awareness and insight questionnaire.
Category
N/A
4
Description
In the experimental group who receive Melissa officinalis capsules: The participants take a dosage of 1200 mg per day mg taken as 2 capsules of 600 mg from the first day of the menstrual cycle for 3 cycles. Researcher calls the research unit at least 3 to 4 times and talks to them call them for guidance. Capsules are given to the students monthly. The participants complete the questionnaires at the end of each month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Narjas High school
Full name of responsible person
Ms. Mesforosh
Street address
Somayeh st., Gas square, Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Tohid High school
Full name of responsible person
Ms. Ahmadi
Street address
Bahar intersection, Shiraz
City
Shiraz
3
Recruitment center
Name of recruitment center
Erfan High school
Full name of responsible person
Ms.Moghadam
Street address
Parbast bridge, Shiraz
City
Shiraz
4
Recruitment center
Name of recruitment center
Fateme-Al-Zahra High school
Full name of responsible person
Ms. Laila Balaghi
Street address
Darion
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Central building of Shiraz University of Medical Sciences Shiraz, Zand Blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Ms of Midwifery
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Nemazee square
City
Shiraz
Postal code
713451978
Phone
+98 71 1647 4254
Fax
Email
akbarzadehmarzieh@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Ms of Midwifery
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Nemazee square
City
Shiraz
Postal code
713451978
Phone
+98 71 1647 4254
Fax
Email
akbarzadehmarzieh@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mansoreh Dehghani
Position
Ms of Midwifery
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Nemazee square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1821 9532
Fax
Email
dehghani-ma@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)