Protocol summary
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Study aim
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compare the effectiveness of a school-based education by peer group vs health practitioner on PMS severity in adolescnt
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Design
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a three-armed parallel-group non-randomized non-masked clinical trial with the comparison group of 90 participants
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Settings and conduct
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In all of the 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 to peer educators(6 sessions) and then to intervention groups simultaneously by midwife counselor and peer educators six online sessions (60 min) in WhatsApp. After the intervention, the DRSP questionnaire will be completed in two consecutive periods by the students of the 3 groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria :
single; moderate to severe PMS according to the (PSST); regular menstrual periods (21 to 35 days); not a professional athlete
, The satisfaction of students and their parents to attend the study, Regular menstruation for 21to35 days
Exclusion criteria:
use of therapies due to PMS; hormonal or psychiatric drug intake affecting PMS; diagnosis of a chronic disease; and occurrence of unfortunate/stressful events for adolescents or their family in the last six months and during the study.
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Intervention groups
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1-First Intervention Group (IG1) : peer-group education
2- Second Intervention Group (IG2) : health practitioner group education
3- Comparison Group (CG)
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Main outcome variables
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1- PMS severity: primary outcome;
2- PMDD frequency: secondary outcome;
3- General Health status: secondary outcome.
General information
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Reason for update
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(1) The research team decides to conduct the study with new approaches in clinical trial studies, so the initial version will be changed in some areas.
(2) Due to the prevalence of coronary heart disease, school closures, and the impossibility of holding face-to-face sessions, the research team decided to hold distance learning sessions (online).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150608022609N5
Registration date:
2019-08-04, 1398/05/13
Registration timing:
prospective
Last update:
2020-09-16, 1399/06/26
Update count:
2
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Registration date
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2019-08-04, 1398/05/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Mazandaran University of Medical Sciences
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Expected recruitment start date
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2020-04-04, 1399/01/16
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Expected recruitment end date
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2020-08-31, 1399/06/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A Comparison between the Effects of School-based Education Programs provided by Peer Group versus Health Practitioners on Premenstrual Syndrome in Adolescents
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Public title
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Effect of peer education on premenstrual syndrome
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
single
satisfaction of students and their parents attending the study,
, regular period of menstruation from 21 to 35 days
moderate to severe PMS according to the Premenstrual Syndrome Screening Tool (PSST)
not a professional athlete
Exclusion criteria:
use of therapies due to PMS, at baseline and during the study
hormonal or psychiatric drug intake affecting PMS, at baseline and during the study
diagnosis of a chronic disease
occurrence of unfortunate/stressful events for adolescents or their family in the last six months and during the study
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Age
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From 16 years old to 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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1- from purposefully selected high schools in Iran’s educational system 2- Randomization at school level (using a random number table) and Allocated to peer-group education (IG1), health practitioner group education (IG2) and comparison group (CG). 3- Random selection of the eligible students in each group based on the required sample size, n=30, (using the built-in random number generator in Microsoft Excel)
Ethics committees
1
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Ethics committee
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Approval date
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2017-07-23, 1396/05/01
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Ethics committee reference number
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Ir.mazums.REC.1396.9188
Health conditions studied
1
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Description of health condition studied
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Premenstrual syndrome
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ICD-10 code
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N94.3
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ICD-10 code description
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Premenstrual tension syndrome
Primary outcomes
1
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Description
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severity of premenstrual syndrome
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Timepoint
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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.
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Method of measurement
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Premenstrual Symptoms Screening Tool (PSST) AND Daily Record of Severity of Problems Chart (DRSP)
Secondary outcomes
1
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Description
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frequency of PMDD
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Timepoint
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At the baseline and after the intervention.
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Method of measurement
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PSST questionnaire
2
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Description
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General Health score
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Timepoint
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At the baseline and after the intervention.
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Method of measurement
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General Health Questionnaire- 28 Items (GHQ-28)
Intervention groups
1
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Description
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Intervention group (1): Training of peer educators: At first, ten eligible volunteer students will be selected as potential peer educators to educate their peers. They will educate about life skills (include problem-solving, critical thinking, effective communication skills, decision-making, creative thinking, interpersonal relationship skills, self-awareness building skills, empathy, and coping with stress and emotions), puberty, menarche, physiology of menstruation, PMS, and its management (such as dietary changes and the use of aerobic exercise) by PI during six face-to-face 60-minutes sessions, in 3 weeks (twice a week). In the following, six of them who are qualified from school staff as well as PI's point of view will be select as peer educators to implement the intervention. The PI is a Master of Science degree student in midwifery and counseling. Peer group education: Participants in this group (IG1, n=30, three subgroups with ten members) educated by two peer educators in each subgroup in six-60-minutes sessions for 3 weeks (twice a week) which will be supervised by the PI. The sessions will be in form of online in WhatsApp application and include: voice records, audio PowerPoint, short video clips, educational pamphlets, and at the end of every session, sometime will be dedicated to question and answer. The content of sessions will include issues like puberty, menarche and menstrual cycles, PMS, and its management.
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Category
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Lifestyle
2
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Description
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Intervention Group (2): Health practitioner education: Simultaneously with the peer group education, participants in IG2 (n=30) will be educated by a health practitioner in six-60-minutes sessions for 3 weeks (twice a week). The content and delivery route of each session will be similar in two intervention groups.
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Category
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Lifestyle
3
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Description
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Comparison group: The CG (n=30), as well as IGs, will receive school routine education provided by school counselors. In the Iranian educational system, in each school, a counselor position has been defined that she usually answers students' questions in many different areas as well as menstrual concerns.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All data and effects are shared after being unidentifiable and ethical.
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When the data will become available and for how long
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Starting the access period from 2020
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To whom data/document is available
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Researchers working in academia and academia
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Under which criteria data/document could be used
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Analysis and modification of data and other documentation is not permitted
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From where data/document is obtainable
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Farzaneh Babapour
f.bbp1991@gmail.com
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What processes are involved for a request to access data/document
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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
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Comments
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