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IRCT20240717062449N1 IRCT 2024-07-25 Tarbiat Modares University Investigating the Effect of a Mental Health-Based Educational Intervention on the Quality of Life of Girls with Primary Dysmenorrhea Investigating the Effect of Mental Health-Based Educational Intervention Compared to a Control Group on the Quality of Life of Secondary School Girls with Primary Dysmenorrhea 2024-10-05 anticipated 100 Complete https://irct.ir/trial/78034 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Prior to the intervention study, a descriptive-analytical study will be conducted to identify eligible participants. Similarly, in the intervention phase of the study, pre-test questionnaires will be administered to both the control and intervention groups simultaneously to ensure the equivalence of the two groups in terms of the relevant variables. Based on the results of the pre-test, the level of significance and impact of each mental health component (depression, anxiety, and stress) on the quality of life of girls with primary dysmenorrhea will be determined. After the completion of the educational intervention, following the recommendations of scientific sources, the follow-up and study questionnaires will be completed by the intervention and control groups in the first and third menstrual cycles after the last day of the intervention. Weekly follow-up sessions will be conducted with the intervention group to assess adherence to the program and answer questions, Randomization description: Eligible students identified in the first phase of the study will be selected using multistage random sampling and according to the sample size, and will be divided into intervention and control groups using block randomization. There will be 50 participants in each group, for a total of 100 participants. To avoid contamination between groups, the control and intervention groups will be selected from different schools, Blinding description: In this study, since the control and intervention groups are from separate schools, the students will not be aware of their allocation to either the control or intervention group. Additionally, as participants will be identified by code, the data analysts and outcome assessors will be blinded to the names of the participants and the control and intervention groups. N/A Primary dysmenorrhea. Intervention 1: Intervention group:The researcher will introduce themselves and the research goals to the students and provide the necessary explanations. It is important to note that the interests of the students, the analysis of preliminary data, the conditions of the school and the respected teachers, and the opinion of the research group will be considered in the design and implementation of the educational sessions. This will be decided during the course of the research. The intervention group will receive the necessary training on primary dysmenorrhea and preventive behaviours based on mental health. This program may include topics such as: education on the causes and mechanisms of dysmenorrhea, relaxation techniques such as deep breathing, and anxiety and stress management. Weekly follow-up sessions will be conducted with the intervention group to assess adherence to the program and answer questions. Intervention 2: Control group: The control group will consist of 50 female high school students who will not receive any intervention during the study period. They will complete the research questionnaires before the intervention, during the first and third menstrual cycles after the intervention, and the results will be compared and statistically analyzed with the results of the intervention group. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome, can be shared. When: The start of the access period will be 6 months after the publication of the results. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: The data will be sent by official request through academic or organizational e-mail of researchers after confirming and identifying the identity of the sender. Where to obtain: It can be reached through the researcher's email: pegah.teimouri@modares.ac.ir and also through the supervisor's email, Dr. Sedigheh Sadat Tavafian: tavafian@modares.ac.ir. How to obtain: Applicants can apply to receive the results 6 months after the publication of the results by email, and a response will be given one week to ten days after sending the email. Comments:
public Sedigheh Sadat Tavafian
Jalal Al Ahmad, Nasr Bridge, Tarbiat Modares University, Faculty of Medical Sciences, Department of Health Education
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 4547 tavafian@modares.ac.ir Tarbiat Modares University scientific Sedigheh Sadat Tavafian
Jalal Al Ahmad Highway, Nasr Bridge, Faculty of Medical Sciences, Tarbiat Modares University, Department of Health Education
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 4547 tavafian@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Age group 14 to 19 years Registration in second secondary schools Informed and written consent of the student and one of their parents to participate in the study Experience any degree (mild, moderate, severe) of primary dysmenorrhea according to the questionnaire Having a regular menstrual cycle with intervals of 21 to 35 days and duration of 3 to 10 days for at least the last six months Experiencing at least 3 painful menstrual periods in the past 6 months Experience any degree of stress, anxiety and depression according to the questionnaire 14 years 19 years Female Student unwillingness to participate in the study History of reproductive system diseases, surgeries and known chronic diseases Use of birth control pills in the last 6 months Suffering from hormonal disorders or irregular menstruation Having pelvic infections Burning, itching or abnormal vaginal discharge Participation in professional sports activities Complaints of any other pelvic pain as reported by the student History of using psychoactive drugs N94.4 Primary dysmenorrhea Prevention Prevention Intervention group:The researcher will introduce themselves and the research goals to the students and provide the necessary explanations. It is important to note that the interests of the students, the analysis of preliminary data, the conditions of the school and the respected teachers, and the opinion of the research group will be considered in the design and implementation of the educational sessions. This will be decided during the course of the research. The intervention group will receive the necessary training on primary dysmenorrhea and preventive behaviours based on mental health. This program may include topics such as: education on the causes and mechanisms of dysmenorrhea, relaxation techniques such as deep breathing, and anxiety and stress management. Weekly follow-up sessions will be conducted with the intervention group to assess adherence to the program and answer questions. Control group: The control group will consist of 50 female high school students who will not receive any intervention during the study period. They will complete the research questionnaires before the intervention, during the first and third menstrual cycles after the intervention, and the results will be compared and statistically analyzed with the results of the intervention group. Depression score in the 21-question depression, anxiety and stress questionnaire. Timepoint: Before the intervention, the first and third menstrual cycles after the educational intervention. Method of measurement: 21-question depression, anxiety and stress questionnaire. Anxiety score in the 21-question depression, anxiety and stress questionnaire. Timepoint: Before the intervention, the first and third menstrual cycles after the educational intervention. Method of measurement: 21-question depression, anxiety and stress questionnaire. Stress score in the 21-question depression, anxiety and stress questionnaire. Timepoint: Before the intervention, the first and third menstrual cycles after the educational intervention. Method of measurement: 21-question depression, anxiety and stress questionnaire. Menstrual pain score. Timepoint: Before the intervention, the first and third menstrual cycles after the educational intervention. Method of measurement: Visual analog scale. Quality of life score. Timepoint: Before the intervention, the first and third menstrual cycles after the educational intervention. Method of measurement: 12-question quality of life questionnaire. Tarbiat Modares University Approved 2024-06-24 Ethics Committee of Tarbiat Modares University Jalal Al Ahmad Highway, Nasr Bridge, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)