Comparison of the effect of education by peer group and counseling midwife on premenstrual syndrome in adolescent girls
Design
clinical trial with a control group and two parallel intervention groups was randomized
Settings and conduct
In all of Participants, the starting checklist has been checked and then qualified will complete Demographic, General Health and Menstrual Disease Prevention Tools questionnaires. people with PMS, the DRSP will be given up to 2 consecutive periods.Among the Sufferers 10 peer educators will be selected, then 30 people will be randomly selected in each group.PMS and its management according to the protocol designed for peer educators in 6 sessions and then the intervention group 1and2 simultaneously will be taught by the midwife of the counselor and peer educators in the course of 4 45-minute sessions at the school. After intervention, DRSP questionnaire will be completed in 2consecutive periods by the students of the 3 groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
11th Grade Secondary School of Mathematics and Humanities,Single
,severe or moderate premenstrual syndrome,Score 22 and less general health questionnaire,Satisfaction of students and their parents to attend the study,Regular menstruation for 21to35 days
Exclusion criteria:
Death of relatives,parental separation, severe crashes and extensive surgical in the last six months, Professional athletes, Taking, hormonal and psychiatric medications, Chronic diseases, cancers and, coagulation diseases, massage yoga.. are used
Intervention groups
30 grade 11high school students with premenstrual syndrome (PMS) are trained by Midwife Consultant (first intervention) and 30students trained by peer educator (second intervention) and 30 students that do not receive any intervention are the control group.
Main outcome variables
(Improving or worsening) symptoms of premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150608022609N5
Registration date:2019-08-04, 1398/05/13
Registration timing:prospective
Last update:2019-08-04, 1398/05/13
Update count:2
Registration date
2019-08-04, 1398/05/13
Registrant information
Name
Zohre Shahhosseini
Name of organization / entity
Mazandaran Univercity of Medical Science, Nasibe School Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.shahhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of education by counterpart and midwifery counselors on premenstrual syndrome in adolescent girls
Public title
Effect of peer education on premenstrual syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
single
premenstrual syndrome, moderate or severe according to PSST questionnaire
, score 22 and less according to general health questionnaire,
satisfaction of students and their parents attending the study,
, regular period of menstruation from 21 to 35 days
11th Secondary School of Humanities and Mathematics
Exclusion criteria:
Occurrence such as near deaths, parental separation, severe crashes and extensive surgical procedures over the past six months
Athletes are professional
. Use acupressure, massage and yoga
hormonal and psychiatric medications
chronic diseases such as irritable bowel syndrome, cancers and coagulation disorders
Age
From 16 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized assignment at school level: Among the three selected schools, we will randomly select the intervention school number 1, intervention number 2 and the observers group,the names of the three selected schools will be put in a black box which is completely out of seen. The names of schools which dropped out of the box will be respectively named intervention groups number 1,number 2 and observers group
Random assignment at the level of sample participants in the project: Among the screened persons with moderate to severe PMS level in each school, the number of needed samples (the first intervention group 30 persons, the second intervention 40persons, and 30 persons as observers ) We will select a simple randomization using the random numbers of Kendall and Smith. Each student with a moderate to severe PMS level will be given a code number (depending on whether the total number of people in the population is a two-digit or three-digit numbers, also the codes which assigned to the population must be the same; two-digit code like 01, 02, 03). To select sample individuals from the table, we start randomly from any part of the table. We will choose the start point by closing the eye and putting the finger on the table, and selecting the 2 or 3 adjacent digits in the row or column of the table, as needed. We remove the first two or three digits smaller than the population as the first sample, and ignore numbers larger than the size of the population. The chosen number will be actually the individual code number of the population which is chosen as a sample. We will continue to do this until the sample size being completed. Selection of samples for each of the three schools will be done separately from the screened persons. In intervention group number 2, at first, 10 peer educators will be separated from the screened persons, then we will select the rest of the samples as said before .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization using a black box (in the allocation of schools to the control group and interventions 1 and 2) - Simple randomization using random number table (in the selection of samples)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Sari Town, Amir Mazandarani Blvd, shahband St., Mehdi Abad, Nasibe Nursery School
City
Sar
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
Ir.mazums.REC.1396.9188
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Percentage of people with premenstrual syndrome
Timepoint
Daily record of severity of premenstrual syndrome's problems within 2 consecutive months ( 2menstrual cycles)before intervention and within 2 consecutive months( 2menstrual cycles) after the end of the intervention.
Method of measurement
Premenstrual Symptoms Screening Tool (PSST) AND Daily Record of Severity of Problems Chart (DRSP)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training by Midwife Consultant: The training is provided by the midwife of an information exchange between the educator and the general practitioner, with a duration of 4 sessions of 45 to 60 minutes.(Protocol C). The first session of the referral is the expression of the second goals of the menopausal process, the third is premenstrual syndrome and the fourth is the management of premenstrual syndrome.The training will be provided by the Midwife Consultant in the school to 30 students. Training for presentations with PowerPoint and training videos. At the end of the training sessions they will be given a pamphlet.
Category
Lifestyle
2
Description
Intervention group: In peer education ,At first researcher will learn about PMS information and manage it to peer educators in 6 sessions 45 to 60 minutes( Protocol A). The topic of the first session is referencing and the expression of goals, the second and third communication skills training, the fourth process of puberty and menstruation, the fifth of the premenstrual syndrome and the sixth of the management of premenstrual syndrome.Training will be provided by the peer group during 4 sessions of 45 to 60 minutes with the researcher's student (Protocol B). The topic of the first session is the expression of goals, the second is the process of puberty and menstruation, the third is the premenstrual syndrome and the fourth is the management of premenstrual syndrome. Each of the two peer educators is responsible for training to 10 participants (6 peer educators and 30 students). Training for presentations with PowerPoint and training videos. will be given at the end of the training pamphlets.
Category
Lifestyle
3
Description
Control group: No intervention has taken place.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sharif-al-olama high school
Full name of responsible person
Maryam Ghorbani
Street address
Shahband Ave.
City
Sari
Province
Mazandaran
Postal code
4811647366
Phone
+98 11 3332 2200
Email
Maryamghorbani@gmail.com
2
Recruitment center
Name of recruitment center
Navab eliye high school
Full name of responsible person
Mitra Naseri
Street address
Nader Ave, Jomhuri Ave.
City
Sari
Province
Mazandaran
Postal code
4849155356
Phone
+98 11 2227 3962
Email
Mitra-Naseri@yahoo.com
3
Recruitment center
Name of recruitment center
Valiyeasr high school
Full name of responsible person
Zeynab Ghoreyshi
Street address
Alley of Electric Power, Imam Square
City
Sari
Province
Mazandaran
Postal code
4811836542
Phone
+98 11 3336 0440
Email
Zeynab060@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Teacher's Square, Building No. 2 of the University
City
Sari
Province
Mazandaran
Postal code
3397148157
Phone
+98 11 3325 7230
Email
M.saeidi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data and effects are shared after being unidentifiable and ethical.
When the data will become available and for how long
Starting the access period from 2018
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Analysis and modification of data and other documentation is not permitted
From where data/document is obtainable
Farzaneh Babapour
f.bbp1991@gmail.com
What processes are involved for a request to access data/document
Send the email and complete introduction and request the requested file
Adaptation to the terms of submission by the Dedicated Information Engine
Posting if matching