Effectiveness of a mental health-based educational intervention on the quality of life of secondary school girls with primary dysmenorrhea: a study protocol for a randomized controlled trial

Effectiveness of a mental health-based educational intervention on the quality of life of secondary school girls with primary dysmenorrhea: a study protocol for a randomized controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effectiveness of a mental health-based educational intervention on the quality of life of secondary school girls with primary dysmenorrhea: a study protocol for a randomized controlled trial Seyedeh-Pegah Teimouri, Sedighe Sadat Tavafian, Mohammad Hossein Delshad This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5381565/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Dysmenorrhea, the most common menstruation-related problem in adolescents, is a medical term for painful menstrual periods that can be primary or secondary. Primary dysmenorrhea is characterized by painful uterine contractions caused by shedding of the endometrium. There is a positive correlation between the levels of depression, anxiety, and stress experienced by adolescents and the severity of primary dysmenorrhea, and the increase in the severity of dysmenorrhea leads to a decrease in the quality of life. Therefore, adolescents should be educated to develop good lifestyle habits to relieve dysmenorrhea symptoms and further improve their quality of life. Methods This randomized controlled trial (RCT) will be conducted in two phases: The first phase is a descriptive-analytical study. Initially, research questionnaires will be distributed to collect data on demographic variables, menstrual pain severity, depression, anxiety, and stress assessment, as well as health-related quality of life assessment for girls aged 14 to 19. In the second phase of the study, a multi-stage random sampling method will be employed to select intervention and control groups from among the students of each school. The selection will be based on the conducted descriptive-analytical study and the specified inclusion criteria. A pre-test will be conducted to ensure the equivalence of the two groups (control and intervention) concerning the relevant variables. We will then proceed to design and implement the educational program in the intervention group. The results will be compared and evaluated in two phases (the first and third menstrual cycles) following the intervention in both the intervention and control groups. Discussion The present study will evaluate the effects of a mental health-based educational intervention on the quality of life in high school girls suffering from primary dysmenorrhea. The study will first identify key predictors of mental health in primary dysmenorrhea and then design a tailored intervention. Trial registration ClinicalTrials.gov IRCT20240717062449N1. Registered on 25 July 2024 with the IRCTID. Health Education Adolescent Dysmenorrhea Menstruation Mental Health Quality of Life Figures Figure 1 Background Primary dysmenorrhea refers to the painful menstrual cycles that involve cramping in the lower abdomen before or during menstruation period in the absence of any pelvic pathology and are often accompanied by symptoms such as headache, nausea, vomiting, and muscle cramps[ 1 ]. Worldwide, the prevalence of primary dysmenorrhea among women of reproductive age is about 50–90%[ 2 ]. This condition becomes more common during adolescence and tends to decline with advancing age and higher parity[ 2 , 3 ]. Dysmenorrhea is the most prevalent gynecological complaint reported by Iranian women and girls. While several studies have examined its prevalence in Iran, the combined findings indicate that approximately 71% of Iranian girls and women experience primary dysmenorrhea[ 4 ]. Primary dysmenorrhea significantly compromises health-related quality of life (HRQOL), leading to limitations in daily activities, absenteeism, and reduced academic or work performance. Studies indicate that Primary dysmenorrhea is a primary cause of school or work absenteeism among young females, with reported rates ranging from 14–51%. Furthermore, Primary dysmenorrhea has a notable negative impact on HRQOL and productivity, even beyond physical symptoms[ 5 , 6 ]. The pathophysiology of dysmenorrhea is still unclear, but current research strongly suggests that prostaglandins, particularly prostaglandin F2alpha (PGF2α), play a central role in exacerbating the pain experienced during primary dysmenorrhea[ 7 ]. In addition, several factors are related to primary dysmenorrhea, including biological factors such as the age of menarche, whether early or late menarche, bleeding intensity and family history of dysmenorrhea[ 8 , 9 ]. Lifestyle related factors such as nutrition, physical activity and smoking and alcohol consumption[ 10 ]. Psychological factors, such as depression, anxiety, and stress, are closely linked to the experience of primary dysmenorrhea, with research indicating a heightened risk of these mental health issues among individuals with recurrent menstrual discomfort[ 11 , 12 ]. There is a positive correlation between the severity of dysmenorrhea and the level of psychological distress experienced by females[ 13 ]. To effectively address primary dysmenorrhea, it is imperative to increase awareness of its psychological dimensions among students, healthcare professionals, and physicians, and to implement comprehensive management strategies that include psychological interventions, counseling, and pharmacological treatments, thereby mitigating the associated psychological distress[ 14 ]. Psychological interventions targeting cognitive, emotional, and behavioral aspects of dysmenorrhea have demonstrated effectiveness in reducing pain and improving overall well-being[ 15 ]. Education, as a fundamental pillar in changing inappropriate behaviours, plays a vital role in promoting individual health. Regular and targeted educational programs, coupled with accurate teachings, can be effective in altering attitudes, raising awareness, and enhancing the understanding of health-related issues within the target community[ 16 ]. Given the limitations of existing programs for preventing menstrual pain and the fact that adolescents with dysmenorrhea experience higher levels of stress and anxiety compared to healthy individuals, and that increased severity of dysmenorrhea leads to further increases in these problems and a decrease in quality of life, this study aims to design and evaluate a needs-based mental health educational intervention, to improve the quality of life in adolescents with primary dysmenorrhea. Method Study design In this protocol, a double-blind, a randomized control trial (RCT) (control: intervention = 50%:50%), parallel controlled with voluntary participation, and 3 months follow-up will be done. Study setting The present study will be conducted in Gilan province, located in the north of Iran. Iran is a country which is divided into 31 provinces. The first level of country subdivisions of Iran is the provinces[17]. Eligible participants will be selected from Girls aged 14 to 19 studying in public high schools of Rudbar county. The study protocol approved by the Ethics Committee of Tarbiat Modares University and registered in the Iranian Registry of Clinical Trials with the number IRCT20240717062449N1. The enrollment, interview, intervention, and evaluation schedule is shown in Table 1. This protocol was developed and reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [18]. To achieve the objective of the study, the following two phases will be considered (Table 2). Phase 1: Descriptive study The researcher will introduce themselves and the objectives of the study to the students, provide necessary explanations for answering the questions, and collect demographic information using the questionnaires. The visual analogue scale (VAS) for pain, the DASS-21 for depression, anxiety, and stress, and the SF-12 for health-related quality of life will be completed. After completing the questionnaires, the data will be analyzed using appropriate statistical methods to identify mental health predictors of primary dysmenorrhea. Phase 2: The randomized controlled trial Randomized controlled trials (RCTs) are considered the gold standard for determining whether a cause-and-effect relationship exists between an intervention and its outcome. By conducting a well-designed RCT, researchers can generate reliable evidence about the effectiveness and safety of a particular intervention[19]. The flow chart of the randomized controlled protocol is shown in Fig. 1 Eligibility criteria Given that the mean age of menarche among Iranian girls is 12.81 years[20]. Since the onset of menarche is primarily influenced by geographical factors, and the mean age of menarche in northern Iran and the province of Gilan, where the present study will be conducted, was observed to be 12.99 ± 1.33 years[21], and primary dysmenorrhea typically begins six to twelve months after menarche, coinciding with the establishment of ovulatory cycles[22]. As a result, participants will be exclusively girls between 14 and 19 years old. There are certain inclusion criteria for the study. Inclusion criteria include Enrollment in secondary schools in Rudbar County, Informed consent from the student, Experience of any degree (mild, moderate, severe) of primary dysmenorrhea based on the Visual Analog Scale (VAS), Regular menstrual cycles for at least the past six months, Experience of at least 3 painful menstrual periods in the past six months, Experience of any degree of stress, anxiety, and depression based on the questionnaire. Exclusion criteria include Unwillingness or withdrawal from participating in the study, Absence from any of the educational sessions, Change of residence,Incomplete responses to questionnaires , History of reproductive system diseases, surgeries, and known chronic diseases, Hormonal disorders, Pelvic infections, Burning, itching, or abnormal vaginal discharge, Participation in professional sports activities, Complaints of any other pain in the pelvic area as reported by the student and History of using medications affecting the psyche. Intervention The intervention protocol Based on the review of literature, results from the descriptive-analytical study, the latest information from credible scientific sources such as the World Health Organization and the Ministry of Health of Iran, pre-tests, and expert opinions, appropriate educational content will be designed for use in the educational intervention. The educational intervention content will include simple and clear information about primary dysmenorrhea and preventive behaviors based on mental health to improve menstrual pain and quality of life in adolescents.This program may include topics such as the causes and mechanisms of dysmenorrhea, relaxation techniques like deep breathing, and anxiety and stress management. Meanwhile, the control group will not receive any education. After the educational intervention, follow-up and study questionnaires will be completed by the intervention and control groups during the first and third menstrual cycles after the last day of the intervention, as recommended by scientific sources. Weekly follow-up sessions will be held to assess adherence to the program and answer questions for the intervention group. The research team will decide on the dimensions of preventive actions and the necessary points to mention regarding primary dysmenorrhea, as well as the format (in-person or virtual sessions) and methods of intervention based on the results from the data analysis of the first phase of the study. However, it is expected that lecture sessions, group discussions, and educational materials such as pamphlets and instructional videos will be utilized, and this content will be made available to students through accessible social media platforms. It may take 4 to 6 weeks to complete. Recruitment Before recruiting students, the project researchers will present introductory letters and obtain permission from the selected county schools, as well as discuss the project and its requirements. Eligible girls aged 14 to 19 who meet the entry criteria will be included in the study. To prevent any influence between groups, the control group and the intervention group will be selected from different schools. We expect to enroll participants consecutively during a 30-day recruitment period. Eligible students will then be directly informed about the study's objectives and benefits. Potential harms or adverse effects of participating in this study have not been identified. However, if any side effects occur, participants will be promptly assisted. After the completion of the educational intervention and upon confirmation of its effectiveness, the educational materials will also be provided to the control group. Outcomes The main outcome of the present study includes the reduction of depression, anxiety, and stress scores, measured using the 21-item Depression, Anxiety, and Stress Scales (DASS-21) before the intervention, as well as during the first and third menstrual cycles following the educational intervention. Additionally, another outcome of this study is the improvement of quality of life scores, measured using the 12-item Short Form Health Survey (SF-12) before the intervention, as well as during the first and third menstrual cycles after the educational intervention. The secondary outcome of the study involves the reduction of menstrual pain scores, measured using the Visual Analog Scale (VAS) before the intervention, and during the first and third menstrual cycles following the educational intervention. Sample size Considering that the average total number of second secondary female students studying in Rudbar county is about 470 people, sample size was estimated 211 people using Cochran’s formula and considering the type I error (0.05). However, taking into account the 10% possible dropout, it was estimated 235 people in phase 1. Furthermore, considering that the objectives of the present study is to examine the impact of a mental health-based educational intervention on the quality of life of high school girls suffering from primary dysmenorrhea in the Rudbar County of Gilan, and that the individuals are independent of one another, the required sample size for each group (intervention and control) in the second phase of the study will be determined based on similar studies[23]. According to the Pocock's formula, a total of 41 individuals will be needed for each group, with an allowance for a 10% dropout rate, resulting in 45 individuals per group, totaling 90 participants. This sample size was considered sufficient to test the difference between groups at power (80%) and alpha (0.05). Sampling To prevent inter-group influence, different schools will be randomly assigned to either the control group or the intervention group. Schools will be randomly allocated to the control and intervention groups by throwing dice. Then, a list of students who met the entry criteria based on the first phase of the study will be prepared. The required sample size will be randomly selected from each school using a table of random numbers and will be divided into the intervention and control groups using paired blocks. The randomization unit is the school.To ensure allocation concealment, sealed opaque envelopes will be used. The investigator will create the allocation sequence, enroll participants, and assign them to different interventions. Blinding In this study, since the control and intervention groups are in separate schools, students will be unaware of how they were assigned to the control or intervention group. Given that participants will be identified by a code, the individuals analyzing the data and outcomes will be blind to the participants' names and the control and intervention groups. The main researcher of the study will not be blinded. Emergency unblinding is not anticipated. However, in exceptional cases where compelling reasons arise, such as for recruitment purposes, the principal investigator may authorize unblinding. Any deviations from the protocol should be documented in the trial database. Participants personal data is assingned a unique identifier, securely stored in a protected format, and accessible exclusively to the principal investigator. Identifiable information about participants is not disclosed in any manuscripts, reports, or research presentations. Data that will be entered into SPSS will be double checked to promote data quality. Instruments The data collection tools will include a demographic information questionnaire (demographic variables), Visual Analog Scale (VAS) for evaluating menstrual pain, the Depression, Anxiety, and Stress Scale (DASS-21), and the Health-Related Quality of Life Questionnaire (SF-12). The questionnaires will be completed by two groups at all three stages (before the intervention, during the first and third menstrual cycles after the educational intervention). Table 3 shows the general characteristics of the aforementioned instruments. Data analysis The data obtained from the questionnaires will be analyzed using descriptive statistical methods (mean, ratio, frequency, and correlation) and inferential statistical methods (independent t-test, dependent t-test, correlation, and analysis of covariance) if the data is normally distributed. If the data is not normally distributed, appropriate non-parametric methods will be employed for analysis. Subsequently, the obtained information will be analyzed using SPSS ver. 26 software. The difference between the means of the independent groups will also be calculated at 95% confidence interval. P-value < 0.05 will be considered as the statistically significant level. No replacement of study subjects or imputation of missing data will be carried out. Dissemination policy Trial results will be submitted to peer-reviewed journals for publication. Part of the data, such as information regarding the main outcome, can be shared. Discussion The present study focuses on examining the impact of a mental health-based educational intervention on the quality of life in high school girls suffering from primary dysmenorrhea. Given the fact that existing studies acknowledge a lack of sufficient information among girls regarding dysmenorrhea and optimal management methods, and that the information and interventions provided sometimes do not align with the needs of adolescents, it is recommended, based on these studies, that educational programs and interventions be incorporated into educational settings such as schools to address primary dysmenorrhea, modifiable and preventable risk factors, and self-management support. This would help prevent unnecessary interruptions in daily activities[5]. Adolescents are the future leaders and assets of every nation. Undoubtedly, planning for their health is considered a form of investment in national development[24]. Given the importance of maintaining and enhancing the health of adolescent girls in promoting preventive behaviors and reducing painful menstruation, various researchers around the world have emphasized the significance of this issue, albeit separately or by referring to one or two preventive behaviors in this context[25, 26]. Considering that, according to the research group's search, published studies in Iran and globally have not covered certain preventive behaviors, such as approaches to improving mental health despite their importance, we aim to address this gap in our study. The results of previous studies highlight the importance of cost-effective and reliable educational programs on dysmenorrhea, which can be utilized to alleviate symptoms, reduce the use of analgesics, and enhance knowledge regarding primary dysmenorrhea[2, 27]. Therefore, by educating and providing appropriate solutions to girls suffering from primary dysmenorrhea in the context of promoting a healthy lifestyle and subsequently improving their quality of life, significant assistance can be offered to these individuals. Additionally, this approach can help reduce stigma, fear, and shame surrounding menstruation, educate on positive management strategies, and encourage adolescents to seek help for their menstrual concerns. Although numerous studies have been conducted in Iran and various countries regarding the reduction of menstrual pain, many of these studies have not adequately assessed the most significant factors influencing menstrual pain and the needs of the target population in designing intervention programs. Therefore, this study aims to first conduct a descriptive-analytical study to identify the most significant predictors related to mental health in primary dysmenorrhea, and subsequently design and implement an appropriate intervention. Individual, social, and cultural factors such as lifestyle, social support, and societal attitudes towards menstrual pain can significantly influence research outcomes. Another limitation of the present study include the use of a self reporting tool that results will be inevitably affected by the memory error, lack of clarity, and individual biases. This study will evaluate the effect of a mental health-based educational intervention on the quality of life of girls suffering from primary dysmenorrhea in northern Iran. If reported to be effective, this intervention could become an important tool for for alleviating menstrual pain, reducing related disabilities and absences, and boosting productivity and overall well-being among these adolescent girls. Trial status This is the first version of the protocol on 28 October 2024. Recruitment is expected to be completed by January 2025. Abbreviations VAS Visual analog scale HRQOL Health-related quality of life Declarations Acknowledgements The authors would like to express their sincere gratitude to the female high school students of Rudbar County and to the Department of Education of Gilan Province, Iran. Authors’ contributions The initial draft was edited by SP.T,and SS.T. The draft was re-edited and approved by SS.T,and MH.D. Authors read and approved the final revised manuscript. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Availability of data and materials Non-applicable participant-level data will not be shared. Ethics approval and consent to participate This study has received the Code of Ethics in Research from the Research Council of Tarbiat Modares University under the number IR.MODARES.REC.1403.042 and the Clinical Trial Code from the Clinical Trial Center of Iran. Informed consent will be obtained from all study participants, clearly specifying how their data will be used and protected. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. References ACOG. ACOG Committee Opinion No. 760: dysmenorrhea and endometriosis in the adolescent. Obstet Gynecol. 2018;132(6):e249-58. Al Ajeel LY, Chong MC, Tang LY, Wong LP, Al Raimi AM. The effect of health education on knowledge and self-care among Arabic schoolgirls with primary dysmenorrhea in Malaysia. The Journal for Nurse Practitioners. 2020;16(10):762-7. Wong CL. Health-related quality of life among Chinese adolescent girls with Dysmenorrhoea. Reproductive Health. 2018;15:1-10. Kharaghani R, Damghanian M. The prevalence of dysmenorrhea in Iran: a systematic review and meta-analysis. 2017. Karout S, Soubra L, Rahme D, Karout L, Khojah HM, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC women's health. 2021;21:1-14. Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HM. Primary dysmenorrhea: pathophysiology, diagnosis, and treatment updates. Korean journal of family medicine. 2022;43(2):101. Fajrin I, Alam G, Usman AN. Prostaglandin level of primary dysmenorrhea pain sufferers. Enfermería Clínica. 2020;30:5-9. Francavilla R, Petraroli M, Messina G, Stanyevic B, Bellani AM, Esposito SM, Street ME. Dysmenorrhea: Epidemiology, Causes and Current State of the Art for Treatment. Clinical and Experimental Obstetrics & Gynecology. 2023;50(12):274. Habibi N, Huang MSL, Gan WY, Zulida R, Safavi SM. Prevalence of primary dysmenorrhea and factors associated with its intensity among undergraduate students: a cross-sectional study. Pain Management Nursing. 2015;16(6):855-61. Tsonis O, Gkrozou F, Barmpalia Z, Makopoulou A, Siafaka V. Integrating Lifestyle Focused Approaches into the Management of Primary Dysmenorrhea: Impact on Quality of Life. International Journal of Women's Health. 2021;13(null):327-36. Bajalan Z, Moafi F, MoradiBaglooei M, Alimoradi Z. Mental health and primary dysmenorrhea: a systematic review. Journal of Psychosomatic Obstetrics & Gynecology. 2019;40(3):185-94. Pakpour AH, Kazemi F, Alimoradi Z, Griffiths MD. Depression, anxiety, stress, and dysmenorrhea: a protocol for a systematic review. Systematic Reviews. 2020;9:1-6. 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Trials. 2023;24(1):377. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine. 2013;158(3):200-7. Bhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta obstetricia et gynecologica Scandinavica. 2018;97(4):380-7. Bahrami N, Soleimani MA, Chan YH, Ghojazadeh M, Mirmiran P. Menarche age in Iran: A meta-analysis. Iranian journal of nursing and midwifery research. 2014;19(5):444-50. Asgharnia M, Faraji R, Sharami H, Yadak M, Oudi M. A study of menarcheal age in Northern Iran (Rasht). Oman medical journal. 2009;24(2):95. Kulkarni A, Deb S. Dysmenorrhoea. Obstetrics, Gynaecology & Reproductive Medicine. 2019;29(10):286-91. Rezaei M, Solaimani L, Mohammadinia N. Effect of Educational Intervention Based on PRECEDE Model on Improving Menstrual Health Behaviors Among Female Students. Shiraz E-Medical Journal. 2022;23(12). Panjalipour S, Bostani Khalesi Z, Rezaei Chamani S, Kazemnejad Leili E. Prioritizing the Healthcare Needs of Adolescent Girls in Iran. Journal of Guilan University of Medical Sciences. 2020;29(3):58-71. Li AD, Bellis EK, Girling JE, Jayasinghe YL, Grover SR, Marino JL, Peate M. Unmet needs and experiences of adolescent girls with heavy menstrual bleeding and dysmenorrhea: a qualitative study. Journal of pediatric and adolescent gynecology. 2020;33(3):278-84. Cholbeigi E, Rezaienik S, Safari N, Lissack K, Griffiths MD, Alimoradi Z. Are health promoting lifestyles associated with pain intensity and menstrual distress among Iranian adolescent girls? BMC pediatrics. 2022;22(1):574. Yilmaz B, Sahin N. The effects of a dysmenorrhea support program on university students who had primary dysmenorrhea: a randomized controlled study. Journal of pediatric and adolescent gynecology. 2020;33(3):285-90. Tables Tables 1 to 3 are available in the Supplementary Files section. Supplementary Files SPIRITchecklist.p.teimouri.docx TAbles123.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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12:52:10","extension":"html","order_by":22,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":115919,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-5381565/v1/cca7ae58a75d500d8ed87f6e.html"},{"id":94859303,"identity":"90f57507-9a63-47b0-823b-7eed761e4888","added_by":"auto","created_at":"2025-10-31 12:52:09","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":396315,"visible":true,"origin":"","legend":"\u003cp\u003eThe flow chart of the randomized controlled protocol\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-5381565/v1/d4129af2a7da4ddff7697c1b.jpeg"},{"id":106961646,"identity":"77dd7482-d7ba-48ac-afbd-2dd0d2552dde","added_by":"auto","created_at":"2026-04-15 09:26:26","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":945163,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5381565/v1/46dbb7ab-8419-48e1-b243-e58716dbd099.pdf"},{"id":94985511,"identity":"e9ae3c93-bbee-47cb-8e11-d31c1ab16ae9","added_by":"auto","created_at":"2025-11-03 06:58:19","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":47026,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITchecklist.p.teimouri.docx","url":"https://assets-eu.researchsquare.com/files/rs-5381565/v1/c67dd48551be724deac95b88.docx"},{"id":94859305,"identity":"d0159bc0-8d43-4be4-b968-bceaa29f38a3","added_by":"auto","created_at":"2025-10-31 12:52:09","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":22996,"visible":true,"origin":"","legend":"","description":"","filename":"TAbles123.docx","url":"https://assets-eu.researchsquare.com/files/rs-5381565/v1/fb25751714837c6a7e2301e0.docx"}],"financialInterests":"","formattedTitle":"Effectiveness of a mental health-based educational intervention on the quality of life of secondary school girls with primary dysmenorrhea: a study protocol for a randomized controlled trial","fulltext":[{"header":"Background","content":"\u003cp\u003ePrimary dysmenorrhea refers to the painful menstrual cycles that involve cramping in the lower abdomen before or during menstruation period in the absence of any pelvic pathology and are often accompanied by symptoms such as headache, nausea, vomiting, and muscle cramps[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Worldwide, the prevalence of primary dysmenorrhea among women of reproductive age is about 50\u0026ndash;90%[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. This condition becomes more common during adolescence and tends to decline with advancing age and higher parity[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Dysmenorrhea is the most prevalent gynecological complaint reported by Iranian women and girls. While several studies have examined its prevalence in Iran, the combined findings indicate that approximately 71% of Iranian girls and women experience primary dysmenorrhea[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePrimary dysmenorrhea significantly compromises health-related quality of life (HRQOL), leading to limitations in daily activities, absenteeism, and reduced academic or work performance. Studies indicate that Primary dysmenorrhea is a primary cause of school or work absenteeism among young females, with reported rates ranging from 14\u0026ndash;51%. Furthermore, Primary dysmenorrhea has a notable negative impact on HRQOL and productivity, even beyond physical symptoms[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe pathophysiology of dysmenorrhea is still unclear, but current research strongly suggests that prostaglandins, particularly prostaglandin F2alpha (PGF2α), play a central role in exacerbating the pain experienced during primary dysmenorrhea[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn addition, several factors are related to primary dysmenorrhea, including biological factors such as the age of menarche, whether early or late menarche, bleeding intensity and family history of dysmenorrhea[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Lifestyle related factors such as nutrition, physical activity and smoking and alcohol consumption[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Psychological factors, such as depression, anxiety, and stress, are closely linked to the experience of primary dysmenorrhea, with research indicating a heightened risk of these mental health issues among individuals with recurrent menstrual discomfort[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. There is a positive correlation between the severity of dysmenorrhea and the level of psychological distress experienced by females[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eTo effectively address primary dysmenorrhea, it is imperative to increase awareness of its psychological dimensions among students, healthcare professionals, and physicians, and to implement comprehensive management strategies that include psychological interventions, counseling, and pharmacological treatments, thereby mitigating the associated psychological distress[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Psychological interventions targeting cognitive, emotional, and behavioral aspects of dysmenorrhea have demonstrated effectiveness in reducing pain and improving overall well-being[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eEducation, as a fundamental pillar in changing inappropriate behaviours, plays a vital role in promoting individual health. Regular and targeted educational programs, coupled with accurate teachings, can be effective in altering attitudes, raising awareness, and enhancing the understanding of health-related issues within the target community[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Given the limitations of existing programs for preventing menstrual pain and the fact that adolescents with dysmenorrhea experience higher levels of stress and anxiety compared to healthy individuals, and that increased severity of dysmenorrhea leads to further increases in these problems and a decrease in quality of life, this study aims to design and evaluate a needs-based mental health educational intervention, to improve the quality of life in adolescents with primary dysmenorrhea.\u003c/p\u003e"},{"header":"Method","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this protocol, a double-blind, a randomized control trial (RCT) (control: intervention = 50%:50%), parallel controlled with voluntary participation, and 3\u0026nbsp;months follow-up will be done.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy setting\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe present study will be conducted in Gilan province, located in the north of Iran. Iran is a country which is divided into 31 provinces. The first level of country subdivisions of Iran is the provinces[17]. Eligible participants will be selected from Girls aged 14 to 19 studying in public high schools of Rudbar county. The study protocol approved by the Ethics Committee of Tarbiat Modares University and registered in the Iranian Registry of Clinical Trials with the number\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eIRCT20240717062449N1. The enrollment, interview, intervention, and evaluation schedule is shown in Table 1. This protocol was developed and reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [18]. To achieve the objective of the study, the following two phases will be considered\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003e(Table 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePhase 1: Descriptive study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe researcher will introduce themselves and the objectives of the study to the students, provide necessary explanations for answering the questions, and collect demographic information using the questionnaires. The visual analogue scale (VAS) for pain, the DASS-21 for depression, anxiety, and stress, and the SF-12 for health-related quality of life will be completed. After completing the questionnaires, the data will be analyzed using appropriate statistical methods to identify mental health predictors of primary dysmenorrhea.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePhase 2: The randomized controlled trial\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRandomized controlled trials (RCTs) are considered the gold standard for determining whether a cause-and-effect relationship exists between an intervention and its outcome. By conducting a well-designed RCT, researchers can generate reliable evidence about the effectiveness and safety of a particular intervention[19].\u0026nbsp;The flow chart of the randomized controlled protocol is shown in Fig. 1\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGiven that the mean age of menarche among Iranian girls is 12.81 years[20]. Since the onset of menarche is primarily influenced by geographical factors, and the mean age of menarche in northern Iran and the province of Gilan, where the present study will be conducted, was observed to be 12.99 \u0026plusmn; 1.33 years[21], and \u0026nbsp;primary dysmenorrhea typically begins six to twelve months after menarche, coinciding with the establishment of ovulatory cycles[22]. As a result, participants will be exclusively girls between 14 and 19 years old. There are certain inclusion criteria for the study. Inclusion criteria include\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eEnrollment in secondary schools in Rudbar County,\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eInformed consent from the student, Experience of any degree (mild, moderate, severe) of primary dysmenorrhea based on the Visual Analog Scale (VAS), Regular menstrual cycles for at least the past six months, Experience of at least 3 painful menstrual periods in the past six months, Experience of any degree of stress, anxiety, and depression based on the questionnaire. Exclusion criteria include\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eUnwillingness or withdrawal from participating in the study, Absence from any of the educational sessions, Change of residence,Incomplete responses to questionnaires\u003cstrong\u003e,\u0026nbsp;\u003c/strong\u003eHistory of reproductive system diseases, surgeries, and known chronic diseases, Hormonal disorders, Pelvic infections, Burning, itching, or abnormal vaginal discharge, Participation in professional sports activities, Complaints of any other pain in the pelvic area as reported by the student and History of using medications affecting the psyche.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention protocol\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eBased on the review of literature, results from the descriptive-analytical study, the latest information from credible scientific sources such as the World Health Organization and the Ministry of Health of Iran, pre-tests, and expert opinions, appropriate educational content will be designed for use in the educational intervention. The educational intervention content will include simple and clear information about primary dysmenorrhea and preventive behaviors based on mental health to improve menstrual pain and quality of life in adolescents.This program may include topics such as the causes and mechanisms of dysmenorrhea, relaxation techniques like deep breathing, and anxiety and stress management. Meanwhile, the control group will not receive any education. After the educational intervention, follow-up and study questionnaires will be completed by the intervention and control groups during the first and third menstrual cycles after the last day of the intervention, as recommended by scientific sources. Weekly follow-up sessions will be held to assess adherence to the program and answer questions for the intervention group.\u003c/p\u003e\n\u003cp\u003eThe research team will decide on the dimensions of preventive actions and the necessary points to mention regarding primary dysmenorrhea, as well as the format (in-person or virtual sessions) and methods of intervention based on the results from the data analysis of the first phase of the study. However, it is expected that lecture sessions, group discussions, and educational materials such as pamphlets and instructional videos will be utilized, and this content will be made available to students through accessible social media platforms. It may take 4 to 6 weeks to complete.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBefore recruiting students, the project researchers\u0026nbsp;will present introductory letters and obtain permission from the selected county schools, as well as discuss the project and its requirements.\u0026nbsp;Eligible girls aged 14 to 19 who meet the entry criteria will be included in the study. To prevent any influence between groups, the control group and the intervention group will be selected from different schools. We expect to enroll participants consecutively during a 30-day recruitment period. Eligible students will then be directly informed about the study\u0026apos;s objectives and benefits.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePotential harms or adverse effects of participating in this study have not been identified. However, if any side effects occur, participants will be promptly assisted. After the completion of the educational intervention and upon confirmation of its effectiveness, the educational materials will also be provided to the control group.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe main outcome of the present study includes the reduction of depression, anxiety, and stress scores, measured using the 21-item Depression, Anxiety, and Stress Scales (DASS-21) before the intervention, as well as during the first and third menstrual cycles following the educational intervention.\u003c/p\u003e\n\u003cp\u003eAdditionally, another outcome of this study is the improvement of quality of life scores, measured using the 12-item Short Form Health Survey (SF-12) before the intervention, as well as during the first and third menstrual cycles after the educational intervention.\u003c/p\u003e\n\u003cp\u003eThe secondary outcome of the study involves the reduction of menstrual pain scores, measured using the Visual Analog Scale (VAS) before the intervention, and during the first and third menstrual cycles following the educational intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsidering that the average total number of second secondary female students studying in Rudbar county is about 470 people, sample size was estimated 211 people using Cochran\u0026rsquo;s formula and considering the type I error (0.05). However, taking into account the 10% possible dropout, it was estimated 235 people in phase 1.\u003c/p\u003e\n\u003cp\u003eFurthermore, considering that the objectives of the present study is to examine the impact of a mental health-based educational intervention on the quality of life of high school girls suffering from primary dysmenorrhea in the Rudbar County of Gilan, and that the individuals are independent of one another, the required sample size for each group (intervention and control) in the second phase of the study will be determined based on similar studies[23]. According to the Pocock\u0026apos;s formula, a total of 41 individuals will be needed for each group, with an allowance for a 10% dropout rate, resulting in 45 individuals per group, totaling 90 participants. This sample size was considered sufficient to test the difference between groups at power (80%) and alpha (0.05).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSampling\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo prevent inter-group influence, different schools will be randomly assigned to either the control group or the intervention group. Schools will be randomly allocated to the control and intervention groups by throwing dice. Then, a list of students who met the entry criteria based on the first phase of the study\u0026nbsp;will be prepared. The required sample size will be randomly selected from each school using a table of random numbers and will be divided into the intervention and control groups using paired blocks.\u0026nbsp;The randomization unit is the school.To ensure allocation concealment, sealed opaque envelopes will be used. The investigator \u0026nbsp;will create the allocation sequence, enroll participants, and assign them to different interventions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBlinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this study, since the control and intervention groups are in separate schools, students will be unaware of how they were assigned to the control or intervention group. Given that participants will be identified by a code, the individuals analyzing the data and outcomes will be blind to the participants\u0026apos; names and the control and intervention groups. The main researcher of the study will not be blinded.\u003c/p\u003e\n\u003cp\u003eEmergency unblinding is not anticipated. However, in exceptional cases where compelling reasons arise, such as for recruitment purposes, the principal investigator may authorize unblinding. Any deviations from the protocol should be documented in the trial database.\u003c/p\u003e\n\u003cp\u003eParticipants personal data is assingned a unique identifier, securely stored in a protected format, and accessible exclusively to the principal investigator. Identifiable information about participants is not disclosed in any manuscripts, reports, or research presentations. Data that will be entered into SPSS will be double checked to promote data quality.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInstruments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data collection tools will include a demographic information questionnaire (demographic variables), Visual Analog Scale (VAS) for evaluating menstrual pain, the Depression, Anxiety, and Stress Scale (DASS-21), and the Health-Related Quality of Life Questionnaire (SF-12). The questionnaires will be completed by two groups at all three stages (before the intervention, during the first and third menstrual cycles after the educational intervention). Table\u0026nbsp;3 shows the general characteristics of the aforementioned instruments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data obtained from the questionnaires will be analyzed using descriptive statistical methods (mean, ratio, frequency, and correlation) and inferential statistical methods (independent t-test, dependent t-test, correlation, and analysis of covariance) if the data is normally distributed. If the data is not normally distributed, appropriate non-parametric methods will be employed for analysis. Subsequently, the obtained information will be analyzed using SPSS ver. 26 software.\u003c/p\u003e\n\u003cp\u003eThe difference between the means of the independent groups will also be calculated at 95% confidence interval. P-value \u0026lt; 0.05 will be considered as the statistically significant level. No replacement of study subjects or imputation of missing data will be carried out.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination policy\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTrial results will be submitted to peer-reviewed journals for publication. Part of the data, such as information regarding the main outcome, can be shared.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe present study focuses on examining the impact of a mental health-based educational intervention on the quality of life in high school girls suffering from primary dysmenorrhea. Given the fact that existing studies acknowledge a lack of sufficient information among girls regarding dysmenorrhea and optimal management methods, and that the information and interventions provided sometimes do not align with the needs of adolescents, it is recommended, based on these studies, that educational programs and interventions be incorporated into educational settings such as schools to address primary dysmenorrhea, modifiable and preventable risk factors, and self-management support. This would help prevent unnecessary interruptions in daily activities[5].\u003c/p\u003e\n\u003cp\u003eAdolescents are the future leaders and assets of every nation. Undoubtedly, planning for their health is considered a form of investment in national development[24]. Given the importance of maintaining and enhancing the health of adolescent girls in promoting preventive behaviors and reducing painful menstruation, various researchers around the world have emphasized the significance of this issue, albeit separately or by referring to one or two preventive behaviors in this context[25, 26]. Considering that, according to the research group\u0026apos;s search, published studies in Iran and globally have not covered certain preventive behaviors, such as approaches to improving mental health despite their importance, we aim to address this gap in our study.\u003c/p\u003e\n\u003cp\u003eThe results of previous studies highlight the importance of cost-effective and reliable educational programs on dysmenorrhea, which can be utilized to alleviate symptoms, reduce the use of analgesics, and enhance knowledge regarding primary dysmenorrhea[2, 27].\u003c/p\u003e\n\u003cp\u003eTherefore, by educating and providing appropriate solutions to girls suffering from primary dysmenorrhea in the context of promoting a healthy lifestyle and subsequently improving their quality of life, significant assistance can be offered to these individuals. Additionally, this approach can help reduce stigma, fear, and shame surrounding menstruation, educate on positive management strategies, and encourage adolescents to seek help for their menstrual concerns.\u003c/p\u003e\n\u003cp\u003eAlthough numerous studies have been conducted in Iran and various countries regarding the reduction of menstrual pain, many of these studies have not adequately assessed the most significant factors influencing menstrual pain and the needs of the target population in designing intervention programs. Therefore, this study aims to first conduct a descriptive-analytical study to identify the most significant predictors related to mental health in primary dysmenorrhea, and subsequently design and implement an appropriate intervention.\u003c/p\u003e\n\u003cp\u003eIndividual, social, and cultural factors such as lifestyle, social support, and societal attitudes towards menstrual pain can significantly influence research outcomes. Another limitation of the present study include the use of a self reporting tool that results will be inevitably affected by the memory error, lack of clarity, and individual biases.\u003c/p\u003e\n\u003cp\u003eThis study will evaluate the effect of a mental health-based educational intervention on the quality of life of girls suffering from primary dysmenorrhea in northern Iran. If reported to be effective, this intervention could become an important tool for for alleviating menstrual pain, reducing related disabilities and absences, and boosting productivity and overall well-being\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eamong these adolescent girls.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is the first version of the protocol on 28 October 2024. Recruitment is expected to be completed by January 2025.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eVAS \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Visual analog scale\u003c/p\u003e\n\u003cp\u003eHRQOL \u0026nbsp; \u0026nbsp;Health-related quality of life\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to express their sincere gratitude to the female high school students of Rudbar County and to the Department of Education of Gilan Province, Iran.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe initial draft was edited by SP.T,and SS.T. The draft was re-edited and approved by SS.T,and MH.D. Authors read and approved the final revised manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNon-applicable participant-level data will not be shared.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study has received the Code of Ethics in Research from the Research Council of Tarbiat Modares University under the number IR.MODARES.REC.1403.042 and the Clinical Trial Code from the Clinical Trial Center of Iran. Informed consent will be obtained from all study participants, clearly specifying how their data will be used and protected.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Not applicable.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;The authors declare that they have no competing interests.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eACOG. ACOG Committee Opinion No. 760: dysmenorrhea and endometriosis in the adolescent. Obstet Gynecol. 2018;132(6):e249-58.\u003c/li\u003e\n\u003cli\u003eAl Ajeel LY, Chong MC, Tang LY, Wong LP, Al Raimi AM. The effect of health education on knowledge and self-care among Arabic schoolgirls with primary dysmenorrhea in Malaysia. The Journal for Nurse Practitioners. 2020;16(10):762-7.\u003c/li\u003e\n\u003cli\u003eWong CL. Health-related quality of life among Chinese adolescent girls with Dysmenorrhoea. Reproductive Health. 2018;15:1-10.\u003c/li\u003e\n\u003cli\u003eKharaghani R, Damghanian M. The prevalence of dysmenorrhea in Iran: a systematic review and meta-analysis. 2017.\u003c/li\u003e\n\u003cli\u003eKarout S, Soubra L, Rahme D, Karout L, Khojah HM, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC women\u0026apos;s health. 2021;21:1-14.\u003c/li\u003e\n\u003cli\u003eItani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HM. Primary dysmenorrhea: pathophysiology, diagnosis, and treatment updates. Korean journal of family medicine. 2022;43(2):101.\u003c/li\u003e\n\u003cli\u003eFajrin I, Alam G, Usman AN. Prostaglandin level of primary dysmenorrhea pain sufferers. Enfermer\u0026iacute;a Cl\u0026iacute;nica. 2020;30:5-9.\u003c/li\u003e\n\u003cli\u003eFrancavilla R, Petraroli M, Messina G, Stanyevic B, Bellani AM, Esposito SM, Street ME. Dysmenorrhea: Epidemiology, Causes and Current State of the Art for Treatment. Clinical and Experimental Obstetrics \u0026amp; Gynecology. 2023;50(12):274.\u003c/li\u003e\n\u003cli\u003eHabibi N, Huang MSL, Gan WY, Zulida R, Safavi SM. Prevalence of primary dysmenorrhea and factors associated with its intensity among undergraduate students: a cross-sectional study. Pain Management Nursing. 2015;16(6):855-61.\u003c/li\u003e\n\u003cli\u003eTsonis O, Gkrozou F, Barmpalia Z, Makopoulou A, Siafaka V. Integrating Lifestyle Focused Approaches into the Management of Primary Dysmenorrhea: Impact on Quality of Life. International Journal of Women\u0026apos;s Health. 2021;13(null):327-36.\u003c/li\u003e\n\u003cli\u003eBajalan Z, Moafi F, MoradiBaglooei M, Alimoradi Z. Mental health and primary dysmenorrhea: a systematic review. Journal of Psychosomatic Obstetrics \u0026amp; Gynecology. 2019;40(3):185-94.\u003c/li\u003e\n\u003cli\u003ePakpour AH, Kazemi F, Alimoradi Z, Griffiths MD. Depression, anxiety, stress, and dysmenorrhea: a protocol for a systematic review. Systematic Reviews. 2020;9:1-6.\u003c/li\u003e\n\u003cli\u003eRogers SK, Ahamadeen N, Chen CX, Mosher CE, Stewart JC, Rand KL. Dysmenorrhea and psychological distress: a meta-analysis. Archives of Women\u0026apos;s Mental Health. 2023;26(6):719-35.\u003c/li\u003e\n\u003cli\u003eAdib-Rad H, Kheirkha F, Faramarzi M, Omidvar S, Basirat Z, Ahmadi MH. Primary dysmenorrhea associated with psychological distress in medical sciences students in the North of Iran: A cross-sectional study. International Journal of Fertility \u0026amp; Sterility. 2022;16(3):224.\u003c/li\u003e\n\u003cli\u003eRogers SK, Galloway A, Hirsh AT, Zapolski T, Chen CX, Rand KL. Efficacy of psychological interventions for dysmenorrhea: a meta-analysis. Pain Medicine. 2023;24(9):1086-99.\u003c/li\u003e\n\u003cli\u003eGlanz K, Rimer BK, Viswanath K. Health behavior: Theory, research, and practice: John Wiley \u0026amp; Sons; 2015.\u003c/li\u003e\n\u003cli\u003eHosseini ZS, Tavafian SS, Ahmadi O, Maghbouli R. Effectiveness of a theory-based educational intervention on work-related musculoskeletal disorders preventive behaviors among assembly-line female workers: a study protocol for a randomized controlled trial. Trials. 2023;24(1):377.\u003c/li\u003e\n\u003cli\u003eChan A-W, Tetzlaff JM, Altman DG, Laupacis A, G\u0026oslash;tzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine. 2013;158(3):200-7.\u003c/li\u003e\n\u003cli\u003eBhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta obstetricia et gynecologica Scandinavica. 2018;97(4):380-7.\u003c/li\u003e\n\u003cli\u003eBahrami N, Soleimani MA, Chan YH, Ghojazadeh M, Mirmiran P. Menarche age in Iran: A meta-analysis. Iranian journal of nursing and midwifery research. 2014;19(5):444-50.\u003c/li\u003e\n\u003cli\u003eAsgharnia M, Faraji R, Sharami H, Yadak M, Oudi M. A study of menarcheal age in Northern Iran (Rasht). Oman medical journal. 2009;24(2):95.\u003c/li\u003e\n\u003cli\u003eKulkarni A, Deb S. Dysmenorrhoea. Obstetrics, Gynaecology \u0026amp; Reproductive Medicine. 2019;29(10):286-91.\u003c/li\u003e\n\u003cli\u003eRezaei M, Solaimani L, Mohammadinia N. Effect of Educational Intervention Based on PRECEDE Model on Improving Menstrual Health Behaviors Among Female Students. Shiraz E-Medical Journal. 2022;23(12).\u003c/li\u003e\n\u003cli\u003ePanjalipour S, Bostani Khalesi Z, Rezaei Chamani S, Kazemnejad Leili E. Prioritizing the Healthcare Needs of Adolescent Girls in Iran. Journal of Guilan University of Medical Sciences. 2020;29(3):58-71.\u003c/li\u003e\n\u003cli\u003eLi AD, Bellis EK, Girling JE, Jayasinghe YL, Grover SR, Marino JL, Peate M. Unmet needs and experiences of adolescent girls with heavy menstrual bleeding and dysmenorrhea: a qualitative study. Journal of pediatric and adolescent gynecology. 2020;33(3):278-84.\u003c/li\u003e\n\u003cli\u003eCholbeigi E, Rezaienik S, Safari N, Lissack K, Griffiths MD, Alimoradi Z. Are health promoting lifestyles associated with pain intensity and menstrual distress among Iranian adolescent girls? BMC pediatrics. 2022;22(1):574.\u003c/li\u003e\n\u003cli\u003eYilmaz B, Sahin N. The effects of a dysmenorrhea support program on university students who had primary dysmenorrhea: a randomized controlled study. Journal of pediatric and adolescent gynecology. 2020;33(3):285-90.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 3 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Health Education, Adolescent, Dysmenorrhea, Menstruation, Mental Health, Quality of Life","lastPublishedDoi":"10.21203/rs.3.rs-5381565/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5381565/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eDysmenorrhea, the most common menstruation-related problem in adolescents, is a medical term for painful menstrual periods that can be primary or secondary. Primary dysmenorrhea is characterized by painful uterine contractions caused by shedding of the endometrium. There is a positive correlation between the levels of depression, anxiety, and stress experienced by adolescents and the severity of primary dysmenorrhea, and the increase in the severity of dysmenorrhea leads to a decrease in the quality of life. Therefore, adolescents should be educated to develop good lifestyle habits to relieve dysmenorrhea symptoms and further improve their quality of life.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis randomized controlled trial (RCT) will be conducted in two phases: The first phase is a descriptive-analytical study. Initially, research questionnaires will be distributed to collect data on demographic variables, menstrual pain severity, depression, anxiety, and stress assessment, as well as health-related quality of life assessment for girls aged 14 to 19. In the second phase of the study, a multi-stage random sampling method will be employed to select intervention and control groups from among the students of each school. The selection will be based on the conducted descriptive-analytical study and the specified inclusion criteria. A pre-test will be conducted to ensure the equivalence of the two groups (control and intervention) concerning the relevant variables. We will then proceed to design and implement the educational program in the intervention group. The results will be compared and evaluated in two phases (the first and third menstrual cycles) following the intervention in both the intervention and control groups.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThe present study will evaluate the effects of a mental health-based educational intervention on the quality of life in high school girls suffering from primary dysmenorrhea. The study will first identify key predictors of mental health in primary dysmenorrhea and then design a tailored intervention.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eClinicalTrials.gov IRCT20240717062449N1. Registered on 25 July 2024 with the IRCTID.\u003c/p\u003e","manuscriptTitle":"Effectiveness of a mental health-based educational intervention on the quality of life of secondary school girls with primary dysmenorrhea: a study protocol for a randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-31 12:52:04","doi":"10.21203/rs.3.rs-5381565/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"640604d3-064f-49b4-916d-285adb7870cb","owner":[],"postedDate":"October 31st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-04-15T06:59:19+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-31 12:52:04","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5381565","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5381565","identity":"rs-5381565","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}