The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome: A Randomized Controlled Trial

The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome: 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 The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome: A Randomized Controlled Trial Aysel Akbeniz, Esra Sabancı Baransel This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9502810/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 Aim: This study aimed to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on premenstrual symptom severity, pre-pregnancy fear of childbirth, and psychological well-being in women experiencing Premenstrual Syndrome (PMS). Materials and Methods: This randomized controlled trial was conducted with 126 women experiencing PMS between June 2023 and November 2025 (MBSR group: n = 63; control group: n = 63). The intervention group participated in an 8-session online MBSR program, delivered twice weekly (40 minutes per session), while the control group received no intervention. Data were collected using the Premenstrual Syndrome Scale (PMSS), the Childbirth Fear – Prior to Pregnancy Scale (CF-PPS), and the Psychological Well-being Scale (PWBS). Between-group differences were analyzed using analysis of covariance (ANCOVA) adjusting for baseline values, and effect sizes were reported using partial eta-squared (η²). The trial was retrospectively registered (ClinicalTrials.gov, NCT06942169). Results: The MBSR intervention was associated with statistically significant improvements in all outcomes compared to the control group. Adjusted analyses indicated a significant reduction in premenstrual symptom severity (p < 0.001, η²=0.117) and fear of childbirth (p < 0.001, η²=0.125), as well as a significant increase in psychological well-being (p < 0.001, η²=0.285). These findings correspond to moderate effect sizes for PMSS and CF-PPS and a near-large effect size for PWBS. Conclusion: The findings suggest that MBSR may be an effective non-pharmacological intervention for reducing premenstrual symptoms, decreasing pre-pregnancy fear of childbirth, and improving psychological well-being in women experiencing PMS. However, the results should be interpreted with caution due to the short-term nature of the assessment and the absence of long-term follow-up data. MBSR Premenstrual Syndrome Childbirth Fear Psychological Well-being Figures Figure 1 Figure 2 Introduction Menstruation is a biological process that begins with puberty in women who are developing healthily, ensures fertility, and continues until menopause. During this process, some women experience a condition accompanied by physical and psychological symptoms in the late luteal phase of the menstrual cycle. This condition is called Premenstrual Syndrome (PMS) and is characterized by symptoms such as depressive mood, anxiety, irritability, fatigue, dizziness, changes in sleep and appetite, breast tenderness, and muscle and joint pain [ 1 , 2 ]. PMS is not only a physiological problem; it is a multifaceted condition that can negatively affect an individual's daily life activities, academic and professional performance, social relationships, and overall psychological well-being [ 3 , 4 ]. Psychological and behavioral changes associated with PMS can lead to increased anxiety and emotional instability in the individual. This situation can lead to the emergence or increase of fear of childbirth in the pre-pregnancy period. Anxiety, low stress tolerance, and intense emotional fluctuations accompanying PMS can negatively affect an individual's expectations and concerns about the birthing process. Studies show that women with high levels of anxiety and stress during the premenstrual period are more likely to develop fear and anxiety related to pregnancy and childbirth [ 5 , 6 ]. Therefore, PMS can be considered a decisive risk factor for prenatal psychological preparation and the perception of safe childbirth. In addition, the effects of PMS on psychological well-being are also important. Psychological well-being is a concept that holistically reflects an individual's positive emotional state, life satisfaction, self-efficacy perception, and capacity to cope with stress. The severity of PMS symptoms can negatively affect an individual's psychological well-being by increasing their stress and anxiety levels. PMS symptoms, particularly depressive mood, irritability, anxiety, and fatigue, can weaken an individual's self-esteem, limit daily functioning, and reduce their quality of life [ 7 , 8 ]. In this context, PMS is not only a condition with physiological symptoms but also one that has statistically significant effects on psychological well-being and prenatal trust. In recent years, psychosocial interventions aimed at managing stress and anxiety have emerged as effective methods in reducing PMS symptoms and related psychological problems. Among these interventions, Mindfulness-Based Stress Reduction (MBSR) programs aim to increase individuals' awareness levels, recognize automatic stress responses, strengthen emotion regulation skills, and improve psychological resilience. The positive effects of MBSR programs on depression, anxiety, stress, and psychological well-being have been supported by research conducted in various clinical and healthy populations [ 9 – 11 ]. In this context, MBSR has the potential to both reduce premenstrual symptoms and mitigate the negative effects of PMS on fear of childbirth and psychological well-being in women experiencing PMS. The literature suggests that MBSR strengthens individuals' psychological resources by reducing anxiety and stress levels, thus potentially having positive effects on fear of childbirth and overall psychological well-being. Therefore, systematically evaluating MBSR intervention in women experiencing PMS fills an important research gap in terms of both symptom management and support for psychological health. Given the aforementioned PMS-related symptoms, increased fear of childbirth, and negative effects on psychological well-being, researching non-pharmacological, holistic, and psychosocial interventions in women experiencing PMS is crucial. Previous studies have demonstrated that mindfulness-based interventions, including MBSR and mindfulness-based cognitive therapy, can effectively reduce premenstrual symptoms such as anxiety, irritability, and mood disturbances [ 12 – 14 ]. These studies primarily focused on symptom reduction and emotional regulation in women experiencing PMS or PMDD. However, the existing literature has largely overlooked the potential relationship between PMS-related psychological distress and pre-pregnancy fear of childbirth. In addition, few studies have examined the combined effects of mindfulness-based interventions on both symptom severity and broader psychological well-being outcomes within the same population. Therefore, the present study contributes to the literature by simultaneously evaluating the effects of an MBSR program on premenstrual symptoms, pre-pregnancy fear of childbirth, and psychological well-being in women experiencing PMS. By integrating these outcomes, this study provides a more comprehensive understanding of the psychosocial impact of MBSR in this population. This study aimed to determine the effects of Mindfulness-Based Stress Reduction (MBSR) training applied to women experiencing PMS on premenstrual symptom levels, pre-pregnancy fear of childbirth, and psychological well-being. Research hypotheses: H1: Premenstrual syndrome scores of women experiencing PMS who participate in the MBSR program will be significantly reduced compared to the control group. H2: Pre-birth fear scores of women experiencing PMS who participate in the MBSR program will be significantly reduced compared to the control group. H3: Psychological well-being scores of women experiencing PMS who participate in the MBSR program will be significantly increased compared to the control group. Materials and methods Study design This study was designed as a randomized-controlled study. The study procedures were approved by the Inonu University Scientific Research and Publication Ethics Committee (Decision No: 4615) and comply with the ethical guidelines outlined in the Helsinki Declaration. This study retrospectively registered Clinical Trials Protocol Registration and Results System (ClinicalTrials.gov), NCT06942169 (Date of registration: 22.01.2026). The retrospective registration was due to administrative and procedural delays at the study initiation stage and was not related to selective outcome reporting or post hoc modifications. No deviations from the original study protocol occurred during the conduct of the trial. In the trial registry, the primary and secondary outcomes were described in general terms, including “premenstrual syndrome severity,” “fear of childbirth,” and “psychological well-being.” In the present manuscript, these outcomes are operationalized using validated and widely used measurement instruments, namely the Premenstrual Syndrome Scale (PMSS), the Childbirth Fear–Prior to Pregnancy Scale (CF-PPS), and the Psychological Well-being Scale (PWBS). This reflects a clarification and specification of outcome assessment rather than a change in outcomes. No outcome switching occurred; all reported outcomes were prespecified in the trial registration, although described in less specific terms. Similarly, the intervention was registered broadly as a Mindfulness-Based Stress Reduction (MBSR) program. In this manuscript, detailed information regarding the intervention content, duration, and delivery format has been provided to enhance transparency and reproducibility. No substantive changes were made to the intervention protocol after study initiation. Furthermore, the study was conducted in accordance with Good Clinical Practice guidelines. All participants signed an informed consent form before starting the study. The study was conducted between June 2023 and November 2025 with women scoring 110 or higher on the PMSS scale. The sample size was calculated using G*Power software (version 3.1.9.2). The calculation was based on the total PMSS score reported by Arıöz and Ege [ 2 ], with an effect size (Cohen’s d) of 0.86 for the primary outcome (premenstrual syndrome severity). A two-tailed independent samples t-test was assumed, with a significance level of α = 0.05, statistical power of 0.95, and an allocation ratio of 1:1. According to the power analysis, the minimum required sample size was 60 participants per group. Considering a potential attrition rate of 5%, the total sample size was increased to 126 participants (63 in each group). The inclusion criteria for the study were: (1) being 18 years of age or older, (2) having regular menstruation (between 21–35 days), and (3) having a total PMS scale score of 110 or higher. The exclusion criteria included: (1) the presence of any gynecological disease (e.g., abnormal uterine bleeding, fibroids, ovarian cysts), and (2) the use of contraceptive pills. Participants who attended fewer than three MBSR sessions were considered non-adherent and were excluded from the final analysis. All participants were eligible at baseline, and adherence was monitored throughout the intervention period. No participants met the exclusion criteria during the intervention period, and all randomized participants were included in the final analysis. Trial setting This trial was conducted in Türkiye between June 2023 and November 2025 and all study procedures (baseline and post-intervention assessments and the MBSR sessions) were delivered online using Google Forms and Zoom, respectively. Randomization Participants were randomly assigned to either the MBSR group or the control group using simple randomization based on computer-generated random numbers, with a 1:1 allocation ratio. The allocation sequence was generated and managed by an independent researcher who was not involved in participant recruitment, intervention delivery, or outcome assessment. The allocation sequence was not accessible to the research team during the assignment process, ensuring allocation concealment. Following allocation, group assignments were necessarily known to the intervention providers due to the nature of the study design. The CONSORT flow diagram of the participants for each stage in this study is presented in Fig. 1 . Blinding Due to the nature of the mindfulness-based training program, participants and intervention providers were not blinded to group allocation. Outcome data were collected using self-report scales administered online. Interventions The intervention applied to the experimental group was a Mindfulness-Based Stress Reduction (MBSR) program based on the standard framework developed by Kabat-Zinn [ 9 ] and adapted by the researchers to suit the online delivery format and the specific characteristics of the study population. The program was delivered by a practitioner who had received formal training in mindfulness-based approaches. The intervention was conducted via Zoom and consisted of a total of eight sessions, each lasting 40 minutes and delivered twice a week. The intervention was delivered online to enhance accessibility and feasibility, allowing participants to attend sessions regardless of time and location constraints. Online delivery was also considered beneficial in improving participation rates and reducing potential barriers associated with face-to-face interventions. In addition, digital mindfulness-based interventions have been increasingly used in recent years and have demonstrated comparable effectiveness to in-person formats. The program maintained the core components of MBSR, including body scan, mindful breathing, awareness exercises, and emotional regulation practices. Minor adaptations were made to session duration and structure to enhance feasibility and participant engagement in the online setting. Following a preparatory session, participants were guided through structured mindfulness practices in each session, including introduction and awareness, body scan, raisin exercise, exiting autopilot, breath focus, sounds and thoughts meditation, emotional awareness, and mindfulness-based coping strategies. After each session, participants were assigned home practices such as body scan, breath awareness, and thought observation to support regular engagement. Participants in the control group received no intervention during the study period and only completed the pre-test assessment. After the completion of the intervention, post-test data were collected from both groups. At the end of the study, participants in the control group were provided with an informational booklet containing the training content. Data collection In the study, women who met the inclusion criteria and volunteered to participate were first administered the Premenstrual Syndrome Scale (PMSS). Women scoring 110 or higher on the PMSS were considered to be experiencing premenstrual syndrome. After identifying suitable participants, pre-tests were administered by the researchers via Google Forms. Both groups were administered the Demographic Information Form, the Premenstrual Syndrome Scale, the Pre-Pregnancy Fear of Childbirth Scale, and the Psychological Well-being Scale during the pre-test phase. Following the MBSR program in the experimental group, post-test data were collected from both groups. Throughout the research, researchers communicated online with participants, checking for missing or erroneous forms and making necessary corrections. Data were anonymized and securely stored in password-protected systems accessible only to the research team. Measures The Premenstrual Syndrome Scale (PMSS), developed by Gençdoğan, was used to determine premenstrual symptom levels. The Cronbach’s alpha reliability coefficient of the scale is reported as 0.75, while it was found to be 0.77 in this study. The Childbirth Fear – Prior to Pregnancy Scale (CF-PPS), developed by Stoll et al. [ 5 ] and adapted into Turkish by Taşhan and Uçar [ 6 ], was used to assess fear of childbirth. The Cronbach’s alpha was reported as 0.89 in the adaptation study, while it was found to be 0.82 in this study. The Psychological Well-being Scale (PWBS), developed by Diener et al. [ 7 ] and adapted into Turkish by Telef [ 10 ], was used to evaluate psychological well-being. The Cronbach’s alpha coefficient was 0.80 in the Turkish adaptation and 0.78 in this study. Outcome Measures The primary outcome of this randomized controlled trial was the change in total Premenstrual Syndrome Scale (PMSS) score from baseline to post-intervention. Secondary outcomes included changes in fear of childbirth and psychological well-being, assessed using the Childbirth Fear - Prior to Pregnancy Scale (CF-PPS) and the Psychological Well-being Scale (PWBS), respectively. All outcome measures were assessed at two time points: baseline (pre-test) and after completion of the 8-week Mindfulness-Based Stress Reduction (MBSR) program (post-test). For each outcome, changes from baseline to post-intervention were analyzed and compared between the MBSR and control groups. Harms Due to the non-pharmacological nature of the intervention, adverse events were not systematically assessed using a standardized reporting form. However, participants were encouraged to report any discomfort or unintended effects during the intervention period. No adverse events were reported by participants. Statistical analysis Statistical analyses were performed using IBM SPSS Statistics for Windows, Version 25.0. categorical variables were summarized as frequency and percentage, and quantitative variables as mean ± standard deviation. Descriptive statistics were used to summarize sociodemographic characteristics of the participants. In accordance with CONSORT recommendations, no inferential statistical tests were conducted to compare baseline characteristics between groups. Randomization was expected to ensure baseline comparability between groups. To evaluate the effect of the intervention, between-group comparisons were conducted using analysis of covariance (ANCOVA), adjusting for baseline values. Analyses were performed using post-test scores adjusted for pre-intervention values. Effect sizes were reported using partial eta-squared (η²). The significance level was set at p < 0.05. Analyses of PMS subdimensions were conducted as secondary exploratory analyses to provide a more detailed understanding of symptom changes. No formal correction for multiple comparisons was applied; therefore, these findings should be interpreted with caution. Protocol and Statistical Analysis Plan The trial protocol and statistical analysis plan are available from the corresponding author upon reasonable request. We used the CONSORT reporting guideline and completed the CONSORT checklist to improve the transparency and completeness of trial reporting (Fig. 1 ). Results The study was completed with a total of 126 participants (63 in the MBSR group and 63 in the control group). There were no missing outcome data, and all randomized participants completed the pre-test and post-test assessments. The sociodemographic characteristics of participants in the MBSR and control groups were comparable based on descriptive statistics (Table 1 ). In accordance with CONSORT recommendations, no inferential statistical tests were conducted to compare baseline characteristics. Table 1. Sociodemographic Characteristics of Women with Premenstrual Syndrome Table 1. Sociodemographic Characteristics of Women with Premenstrual Syndrome Characteristic MBSR group (n=63) Control group (n=63) n % n % Age 29.76±6.39 31.19±9.32 First menarche age 14.42±2.63 14.01±1.84 Educational level High school and below University and above 20 53 15.9 84.1 18 45 28.6 71.4 Marital status Married Single 34 29 54.0 46.0 32 31 50.8 49.2 Income situation Income less than expenses Income equal to expenses Income greater than expenses 16 40 7 25.4 63.5 11.1 22 33 8 34.9 52.4 12.7 Employment status Employed Unemployed 43 20 68.3 31.7 37 26 58.7 41.3 Table 2 Comparison of Outcome Measures Between the MBSR and Control Groups Treatment Group Pretest Mean (SD) Posttest Adjusted Mean (SD) P-Value Partial Eta 2 PMSS MBSR group 147.47 (41.66) 124.01 a (37.96) < .001 .117 Control group 150.65 (34.86) 145.36 a (16.95) CF-PPS MBSR group 43.82 (1.47) 35.14 a (1.40) < .001 .125 Control group 44.49 (1.48) 43.39 a (1.39) PWBS MBSR group 32.92 (13.05) 44.39 a (10.14) < .001 .285 Control group 34.61 (13.23) 34.38 a (10.15) PMSS: Premenstrual Syndrome Scale, CF-PPS: The Childbirth Fear - Prior to Pregnancy Scale, PWBS: Psychological Well-being Scale, SD: Standard Deviation a Adjusted post-test means were estimated using ANCOVA controlling for baseline values. Table 2 presents the findings regarding the pre- and post-intervention comparisons of the mean PMSS, CF-PPS, and PWBS scores of women in the MBSR and control groups. The findings show that the MBSR program provided a significant improvement in all variables. PMSS scores, which measure the severity of premenstrual syndrome, decreased from 147.47 to 124.01 in the MBSR group, while there was a limited decrease from 150.65 to 145.36 in the control group; this difference is statistically significant (p < .001) and shows a moderate effect size (η² = .117). Similarly, the CF-PPS score, which assesses fear of childbirth, decreased from 43.82 to 35.14 in the MBSR group, while only a small decrease was recorded in the control group (from 44.49 to 43.39); this result was also found to be significant (p < .001, η² = .125). The PWBS score, indicating psychological well-being, significantly increased from 32.92 to 44.39 in the MBSR group, while no improvement was observed in the control group (from 34.61 to 34.38). This increase is statistically significant (p < .001) and shows a relatively large effect size (η² = .285). Overall, the findings suggest that the MBSR intervention is associated with statistically significant improvements in premenstrual symptoms, fear of childbirth, and psychological well-being. Figure 2 illustrates the changes in PMS subdimensions across the study groups from baseline to post-intervention. Descriptively, greater reductions were observed in the MBSR group compared to the control group, particularly in depressive mood, anxiety, irritability, depressive thoughts, pain, and bloating. These analyses were conducted as exploratory, and the findings should be interpreted with caution due to the absence of correction for multiple comparisons. Therefore, these findings should be considered hypothesis-generating rather than confirmatory. Discussion One of the key contributions of this study is the simultaneous examination of premenstrual symptoms, pre-pregnancy fear of childbirth, and psychological well-being within a single randomized controlled design. This integrated approach extends the existing literature, which has predominantly focused on symptom reduction alone. The interpretation of the findings is based on between-group comparisons adjusted for baseline values, in line with recommended statistical approaches for randomized controlled trials. This randomized controlled trial investigated the effects of MBSR on premenstrual symptom severity, prenatal fear of childbirth, and psychological well-being in women experiencing PMS. The findings indicate that the MBSR intervention was associated with statistically significant improvements across all primary and secondary outcomes. The moderate effect sizes observed for PMSS and CF-PPS, together with the near-large effect size for PWBS, suggest that the intervention is associated with improvements of moderate to large magnitude. The findings of this study indicate that the MBSR intervention led to a statistically significant reduction in premenstrual symptom severity compared to the control group, based on adjusted between-group comparisons. The observed moderate effect size further supports the effectiveness of the intervention. These findings are consistent with previous studies reporting that mindfulness-based interventions reduce PMS symptoms and associated psychological distress [ 12 – 14 ]. Exploratory analyses suggested greater improvements in emotional and somatic PMS symptoms in the MBSR group, particularly in depressive mood, anxiety, irritability, depressive thoughts, pain, and bloating. However, as no correction for multiple comparisons was applied, these findings should be interpreted cautiously. This pattern may be explained by the fact that MBSR primarily targets cognitive and emotional regulation processes. Mindfulness practices are known to reduce rumination and stress reactivity while enhancing emotional awareness and self-regulation [ 11 ]. However, symptoms more strongly influenced by biological and circadian mechanisms, such as sleep and appetite, may require longer-term or multimodal interventions. Similarly, a statistically significant reduction in fear of childbirth was observed in the MBSR group compared to the control group. The moderate effect size suggests that the intervention had a meaningful impact on anticipatory childbirth-related concerns. Fear of childbirth is associated with cognitive-emotional processes such as catastrophizing, intolerance of uncertainty, and perceived loss of control. Mindfulness-based interventions may reduce perceived threat by fostering non-judgmental awareness and acceptance of internal experiences. Previous studies conducted with pregnant populations have shown that mindfulness-based programs reduce fear of childbirth and improve psychological outcomes [ 15 , 16 ]. The present findings extend this evidence to the pre-pregnancy period, suggesting a potential preventive role of MBSR. In terms of psychological well-being, the findings indicate a statistically significant improvement in the MBSR group compared to the control group, with a relatively large effect size. However, this finding should be interpreted with caution. In particular, the use of self-reported measures and the potential influence of expectancy effects may have contributed to an overestimation of the observed effect. Previous literature has reported that mindfulness-based interventions can produce small to moderate, and in some cases large, improvements in psychological well-being [ 17 , 11 ]. Therefore, although the findings are generally consistent with the literature, further studies incorporating objective measures and long-term follow-up are needed to confirm the robustness of these effects. Another important consideration is that fear of childbirth was assessed in a non-pregnant population. Therefore, the findings reflect anticipatory perceptions rather than experiences related to actual pregnancy. It is possible that fear levels may differ among women who are actively planning pregnancy compared to those who are not, which was not assessed in the present study. Future research may benefit from considering pregnancy intention as a stratification variable. Overall, the findings suggest that MBSR may be a useful psychosocial intervention for improving both symptom-related and broader psychological outcomes in women experiencing PMS. However, given the multifactorial nature of PMS, such interventions should be considered as part of a comprehensive approach that may include lifestyle modifications, medical treatment, and long-term behavioral support. Limitations The study has some limitations. First, the intervention effects are based only on short-term (pre-test–post-test) measurements. The lack of long-term follow-up data limits inferences about the sustainability of the MBSR program's effects. Future studies are recommended to evaluate the medium- and long-term effects of the intervention with follow-up measurements. Second, the fact that the intervention was conducted online may have had a limiting effect on group interaction, therapeutic bonding, and application intensity compared to face-to-face applications. Therefore, direct generalization of the findings to face-to-face MBSR programs should be considered with caution. Another limitation of this study is the lack of blinding of participants and intervention providers due to the nature of the MBSR program. This may have introduced potential biases such as expectancy effects and reporting bias. In addition, all outcome measures were based on self-reported instruments, which may be subject to social desirability bias. Furthermore, the absence of an active control group limits the ability to distinguish the specific effects of the MBSR intervention from non-specific factors such as attention and participation effects. However, the use of a randomized controlled design, validated measurement tools, and the reporting of effect sizes strengthens the internal validity of the study and partially mitigates these limitations. Finally, the fact that the sample consisted of women with PMS severity above a certain threshold (PMSS ≥ 110) who voluntarily participated in the study may limit the generalizability of the findings to women with milder PMS symptoms or to different sociocultural contexts. Conclusion In conclusion, this study suggests that MBSR may be an effective non-pharmacological approach for reducing premenstrual symptoms, decreasing pre-pregnancy fear of childbirth, and improving psychological well-being in women experiencing PMS. However, given the short-term nature of the assessment and the absence of long-term follow-up data, these findings should be interpreted with caution. MBSR may be considered a promising supportive intervention within women's health services, but further research with longer follow-up periods and diverse populations is needed to confirm its long-term effectiveness and clinical applicability. Declarations Author Contribution AA: Conceptualization, Methodology, Investigation, Data curation, Formal analysis, Writing – original draft, Writing – review & editing, Supervision.ESB: Methodology, Investigation, Data curation, Validation, Writing – review & editing. Data Availability The data that support the findings of this study are available from the corresponding author upon reasonable request. The data are not publicly available due to ethical restrictions and to protect the privacy and confidentiality of the participants. References Arenliu A, Krasniqi S, Ibrahimi A (2016) Premenstrual syndrome and its impact on daily life. Health Psychol Res 4(2):123–130. 10.4081/hpr.2016.123 Arıöz N, Ege E (2013) Premenstrual syndrome: prevalence and severity in Turkish women. J Clin Nurs 22(7–8):1056–1064. 10.1111/jocn.12135 Evliyaoğlu O, Yılmaz H, Kaya A (2010) The effect of premenstrual syndrome on productivity and daily functioning. 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J Midwifery Womens Health 68(5):604–610 Veringa-Skiba IK, de Bruin EI, van Steensel FJA, Bögels SM (2022) Fear of childbirth, nonurgent obstetric interventions, and newborn outcomes: a randomized controlled trial. Birth 49(1):40–51. 10.1111/birt.12571 Van der Meulen RT, Veringa-Skiba IK, van Steensel FJA, Bögels SM, de Bruin EI (2023) Mindfulness-based childbirth and parenting: randomized controlled trial outcomes. Midwifery 116:103545. 10.1016/j.midw.2022.103545 Goyal M, Singh S, Sibinga EMS, Gould NF, Rowland-Seymour A, Sharma R et al (2014) Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med 174(3):357–368. 10.1001/jamainternmed.2013.13018 Gu J, Strauss C, Bond R, Cavanagh K (2015) How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? Clin Psychol Rev 37:1–12. 10.1016/j.cpr.2015.01.006 Kabat-Zinn J (1990) Full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. Delacorte, New York Additional Declarations No competing interests reported. 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. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9502810","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":637110965,"identity":"3121580d-acbc-487d-b756-373794f491ff","order_by":0,"name":"Aysel Akbeniz","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABD0lEQVRIie2RMUvEMBTHnwh2KZyTnBzUTyC8EqgcHPWrvHJglwyOBwp2cqq7oPglhLq+UvCW4hxQsF10uSG3nYuYKrpoqqNDfktCyC//9ycADsd/pQFANCvDjN8PuPlNoS+lZvC7Df1VgbXTDwX6lMF52jYEsdjzzsry5eoh2N+qWpMSB7vZz8pQSYEE02ic3xFvF0/CHx2gUaYiYkuMkhtDgvUJKokcFlWSj6hTOCksyo5Kn1cEJxN8XCAnl52S6l4FFUWmbBWh8pHLrFNkf0pYL4QZbC7GucQyu62Efy8PmdDeJZinrdZwFN54tViujqvAu0ivtZ7FgbX+JpnveP0+sOV6x8D2lsPhcDg+eQMLVmfMSdEfZgAAAABJRU5ErkJggg==","orcid":"","institution":"Tarsus University","correspondingAuthor":true,"prefix":"","firstName":"Aysel","middleName":"","lastName":"Akbeniz","suffix":""},{"id":637110966,"identity":"42b583cd-7344-4911-84ac-c10b34e2744d","order_by":1,"name":"Esra Sabancı Baransel","email":"","orcid":"","institution":"Inonu University","correspondingAuthor":false,"prefix":"","firstName":"Esra","middleName":"Sabancı","lastName":"Baransel","suffix":""}],"badges":[],"createdAt":"2026-04-23 06:23:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9502810/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9502810/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":109009165,"identity":"9154589e-630f-49fb-b338-de451ce65727","added_by":"auto","created_at":"2026-05-11 16:10:20","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":42822,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT diagram of the participants for each stage in this study.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-9502810/v1/d7d89680e4ab651fe94d1f77.png"},{"id":109008901,"identity":"6bd124c4-92af-4bec-b0a4-5738f6e1c13f","added_by":"auto","created_at":"2026-05-11 16:08:19","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":74975,"visible":true,"origin":"","legend":"\u003cp\u003eChanges in PMS Subscale Scores Pre/Post-Test MBSR Intervention in the Study Groups\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-9502810/v1/864f915ea8f143530413f826.png"},{"id":109204522,"identity":"701125ad-427c-48ec-9fc5-6284c8f26b7f","added_by":"auto","created_at":"2026-05-13 15:00:40","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":284066,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9502810/v1/3f13d829-478c-4094-9678-3905a8ba0dc9.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome: A Randomized Controlled Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMenstruation is a biological process that begins with puberty in women who are developing healthily, ensures fertility, and continues until menopause. During this process, some women experience a condition accompanied by physical and psychological symptoms in the late luteal phase of the menstrual cycle. This condition is called Premenstrual Syndrome (PMS) and is characterized by symptoms such as depressive mood, anxiety, irritability, fatigue, dizziness, changes in sleep and appetite, breast tenderness, and muscle and joint pain [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. PMS is not only a physiological problem; it is a multifaceted condition that can negatively affect an individual's daily life activities, academic and professional performance, social relationships, and overall psychological well-being [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePsychological and behavioral changes associated with PMS can lead to increased anxiety and emotional instability in the individual. This situation can lead to the emergence or increase of fear of childbirth in the pre-pregnancy period. Anxiety, low stress tolerance, and intense emotional fluctuations accompanying PMS can negatively affect an individual's expectations and concerns about the birthing process. Studies show that women with high levels of anxiety and stress during the premenstrual period are more likely to develop fear and anxiety related to pregnancy and childbirth [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Therefore, PMS can be considered a decisive risk factor for prenatal psychological preparation and the perception of safe childbirth.\u003c/p\u003e \u003cp\u003eIn addition, the effects of PMS on psychological well-being are also important. Psychological well-being is a concept that holistically reflects an individual's positive emotional state, life satisfaction, self-efficacy perception, and capacity to cope with stress. The severity of PMS symptoms can negatively affect an individual's psychological well-being by increasing their stress and anxiety levels. PMS symptoms, particularly depressive mood, irritability, anxiety, and fatigue, can weaken an individual's self-esteem, limit daily functioning, and reduce their quality of life [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn this context, PMS is not only a condition with physiological symptoms but also one that has statistically significant effects on psychological well-being and prenatal trust. In recent years, psychosocial interventions aimed at managing stress and anxiety have emerged as effective methods in reducing PMS symptoms and related psychological problems. Among these interventions, Mindfulness-Based Stress Reduction (MBSR) programs aim to increase individuals' awareness levels, recognize automatic stress responses, strengthen emotion regulation skills, and improve psychological resilience. The positive effects of MBSR programs on depression, anxiety, stress, and psychological well-being have been supported by research conducted in various clinical and healthy populations [\u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn this context, MBSR has the potential to both reduce premenstrual symptoms and mitigate the negative effects of PMS on fear of childbirth and psychological well-being in women experiencing PMS. The literature suggests that MBSR strengthens individuals' psychological resources by reducing anxiety and stress levels, thus potentially having positive effects on fear of childbirth and overall psychological well-being. Therefore, systematically evaluating MBSR intervention in women experiencing PMS fills an important research gap in terms of both symptom management and support for psychological health. Given the aforementioned PMS-related symptoms, increased fear of childbirth, and negative effects on psychological well-being, researching non-pharmacological, holistic, and psychosocial interventions in women experiencing PMS is crucial.\u003c/p\u003e \u003cp\u003ePrevious studies have demonstrated that mindfulness-based interventions, including MBSR and mindfulness-based cognitive therapy, can effectively reduce premenstrual symptoms such as anxiety, irritability, and mood disturbances [\u003cspan additionalcitationids=\"CR13\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. These studies primarily focused on symptom reduction and emotional regulation in women experiencing PMS or PMDD.\u003c/p\u003e \u003cp\u003eHowever, the existing literature has largely overlooked the potential relationship between PMS-related psychological distress and pre-pregnancy fear of childbirth. In addition, few studies have examined the combined effects of mindfulness-based interventions on both symptom severity and broader psychological well-being outcomes within the same population.\u003c/p\u003e \u003cp\u003eTherefore, the present study contributes to the literature by simultaneously evaluating the effects of an MBSR program on premenstrual symptoms, pre-pregnancy fear of childbirth, and psychological well-being in women experiencing PMS. By integrating these outcomes, this study provides a more comprehensive understanding of the psychosocial impact of MBSR in this population.\u003c/p\u003e \u003cp\u003eThis study aimed to determine the effects of Mindfulness-Based Stress Reduction (MBSR) training applied to women experiencing PMS on premenstrual symptom levels, pre-pregnancy fear of childbirth, and psychological well-being.\u003c/p\u003e\n\u003ch3\u003eResearch hypotheses:\u003c/h3\u003e\n\u003cp\u003eH1: Premenstrual syndrome scores of women experiencing PMS who participate in the MBSR program will be significantly reduced compared to the control group.\u003c/p\u003e \u003cp\u003eH2: Pre-birth fear scores of women experiencing PMS who participate in the MBSR program will be significantly reduced compared to the control group.\u003c/p\u003e \u003cp\u003eH3: Psychological well-being scores of women experiencing PMS who participate in the MBSR program will be significantly increased compared to the control group.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThis study was designed as a randomized-controlled study. The study procedures were approved by the Inonu University Scientific Research and Publication Ethics Committee (Decision No: 4615) and comply with the ethical guidelines outlined in the Helsinki Declaration. This study retrospectively registered Clinical Trials Protocol Registration and Results System (ClinicalTrials.gov), NCT06942169 (Date of registration: 22.01.2026). The retrospective registration was due to administrative and procedural delays at the study initiation stage and was not related to selective outcome reporting or post hoc modifications. No deviations from the original study protocol occurred during the conduct of the trial.\u003c/p\u003e \u003cp\u003eIn the trial registry, the primary and secondary outcomes were described in general terms, including \u0026ldquo;premenstrual syndrome severity,\u0026rdquo; \u0026ldquo;fear of childbirth,\u0026rdquo; and \u0026ldquo;psychological well-being.\u0026rdquo; In the present manuscript, these outcomes are operationalized using validated and widely used measurement instruments, namely the Premenstrual Syndrome Scale (PMSS), the Childbirth Fear\u0026ndash;Prior to Pregnancy Scale (CF-PPS), and the Psychological Well-being Scale (PWBS). This reflects a clarification and specification of outcome assessment rather than a change in outcomes. No outcome switching occurred; all reported outcomes were prespecified in the trial registration, although described in less specific terms.\u003c/p\u003e \u003cp\u003eSimilarly, the intervention was registered broadly as a Mindfulness-Based Stress Reduction (MBSR) program. In this manuscript, detailed information regarding the intervention content, duration, and delivery format has been provided to enhance transparency and reproducibility. No substantive changes were made to the intervention protocol after study initiation. Furthermore, the study was conducted in accordance with Good Clinical Practice guidelines. All participants signed an informed consent form before starting the study.\u003c/p\u003e \u003cp\u003eThe study was conducted between June 2023 and November 2025 with women scoring 110 or higher on the PMSS scale. The sample size was calculated using G*Power software (version 3.1.9.2). The calculation was based on the total PMSS score reported by Arı\u0026ouml;z and Ege [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], with an effect size (Cohen\u0026rsquo;s d) of 0.86 for the primary outcome (premenstrual syndrome severity). A two-tailed independent samples t-test was assumed, with a significance level of α\u0026thinsp;=\u0026thinsp;0.05, statistical power of 0.95, and an allocation ratio of 1:1.\u003c/p\u003e \u003cp\u003e According to the power analysis, the minimum required sample size was 60 participants per group. Considering a potential attrition rate of 5%, the total sample size was increased to 126 participants (63 in each group). The inclusion criteria for the study were: (1) being 18 years of age or older, (2) having regular menstruation (between 21\u0026ndash;35 days), and (3) having a total PMS scale score of 110 or higher. The exclusion criteria included: (1) the presence of any gynecological disease (e.g., abnormal uterine bleeding, fibroids, ovarian cysts), and (2) the use of contraceptive pills. Participants who attended fewer than three MBSR sessions were considered non-adherent and were excluded from the final analysis. All participants were eligible at baseline, and adherence was monitored throughout the intervention period. No participants met the exclusion criteria during the intervention period, and all randomized participants were included in the final analysis.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eTrial setting\u003c/h3\u003e\n\u003cp\u003eThis trial was conducted in T\u0026uuml;rkiye between June 2023 and November 2025 and all study procedures (baseline and post-intervention assessments and the MBSR sessions) were delivered online using Google Forms and Zoom, respectively.\u003c/p\u003e\n\u003ch3\u003eRandomization\u003c/h3\u003e\n\u003cp\u003eParticipants were randomly assigned to either the MBSR group or the control group using simple randomization based on computer-generated random numbers, with a 1:1 allocation ratio.\u003c/p\u003e \u003cp\u003eThe allocation sequence was generated and managed by an independent researcher who was not involved in participant recruitment, intervention delivery, or outcome assessment. The allocation sequence was not accessible to the research team during the assignment process, ensuring allocation concealment.\u003c/p\u003e \u003cp\u003eFollowing allocation, group assignments were necessarily known to the intervention providers due to the nature of the study design. The CONSORT flow diagram of the participants for each stage in this study is presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003ch3\u003eBlinding\u003c/h3\u003e\n\u003cp\u003eDue to the nature of the mindfulness-based training program, participants and intervention providers were not blinded to group allocation. Outcome data were collected using self-report scales administered online.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eInterventions\u003c/h2\u003e \u003cp\u003eThe intervention applied to the experimental group was a Mindfulness-Based Stress Reduction (MBSR) program based on the standard framework developed by Kabat-Zinn [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] and adapted by the researchers to suit the online delivery format and the specific characteristics of the study population. The program was delivered by a practitioner who had received formal training in mindfulness-based approaches.\u003c/p\u003e \u003cp\u003eThe intervention was conducted via Zoom and consisted of a total of eight sessions, each lasting 40 minutes and delivered twice a week. The intervention was delivered online to enhance accessibility and feasibility, allowing participants to attend sessions regardless of time and location constraints. Online delivery was also considered beneficial in improving participation rates and reducing potential barriers associated with face-to-face interventions. In addition, digital mindfulness-based interventions have been increasingly used in recent years and have demonstrated comparable effectiveness to in-person formats.\u003c/p\u003e \u003cp\u003eThe program maintained the core components of MBSR, including body scan, mindful breathing, awareness exercises, and emotional regulation practices. Minor adaptations were made to session duration and structure to enhance feasibility and participant engagement in the online setting.\u003c/p\u003e \u003cp\u003e Following a preparatory session, participants were guided through structured mindfulness practices in each session, including introduction and awareness, body scan, raisin exercise, exiting autopilot, breath focus, sounds and thoughts meditation, emotional awareness, and mindfulness-based coping strategies. After each session, participants were assigned home practices such as body scan, breath awareness, and thought observation to support regular engagement.\u003c/p\u003e \u003cp\u003eParticipants in the control group received no intervention during the study period and only completed the pre-test assessment. After the completion of the intervention, post-test data were collected from both groups. At the end of the study, participants in the control group were provided with an informational booklet containing the training content.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eData collection\u003c/h3\u003e\n\u003cp\u003eIn the study, women who met the inclusion criteria and volunteered to participate were first administered the Premenstrual Syndrome Scale (PMSS). Women scoring 110 or higher on the PMSS were considered to be experiencing premenstrual syndrome. After identifying suitable participants, pre-tests were administered by the researchers via Google Forms.\u003c/p\u003e \u003cp\u003eBoth groups were administered the Demographic Information Form, the Premenstrual Syndrome Scale, the Pre-Pregnancy Fear of Childbirth Scale, and the Psychological Well-being Scale during the pre-test phase. Following the MBSR program in the experimental group, post-test data were collected from both groups.\u003c/p\u003e \u003cp\u003e Throughout the research, researchers communicated online with participants, checking for missing or erroneous forms and making necessary corrections. Data were anonymized and securely stored in password-protected systems accessible only to the research team.\u003c/p\u003e\n\u003ch3\u003eMeasures\u003c/h3\u003e\n\u003cp\u003eThe Premenstrual Syndrome Scale (PMSS), developed by Gen\u0026ccedil;doğan, was used to determine premenstrual symptom levels. The Cronbach\u0026rsquo;s alpha reliability coefficient of the scale is reported as 0.75, while it was found to be 0.77 in this study.\u003c/p\u003e \u003cp\u003eThe Childbirth Fear \u0026ndash; Prior to Pregnancy Scale (CF-PPS), developed by Stoll et al. [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] and adapted into Turkish by Taşhan and U\u0026ccedil;ar [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], was used to assess fear of childbirth. The Cronbach\u0026rsquo;s alpha was reported as 0.89 in the adaptation study, while it was found to be 0.82 in this study.\u003c/p\u003e \u003cp\u003eThe Psychological Well-being Scale (PWBS), developed by Diener et al. [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] and adapted into Turkish by Telef [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], was used to evaluate psychological well-being. The Cronbach\u0026rsquo;s alpha coefficient was 0.80 in the Turkish adaptation and 0.78 in this study.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eOutcome Measures\u003c/h2\u003e \u003cp\u003eThe primary outcome of this randomized controlled trial was the change in total Premenstrual Syndrome Scale (PMSS) score from baseline to post-intervention. Secondary outcomes included changes in fear of childbirth and psychological well-being, assessed using the Childbirth Fear - Prior to Pregnancy Scale (CF-PPS) and the Psychological Well-being Scale (PWBS), respectively.\u003c/p\u003e \u003cp\u003eAll outcome measures were assessed at two time points: baseline (pre-test) and after completion of the 8-week Mindfulness-Based Stress Reduction (MBSR) program (post-test). For each outcome, changes from baseline to post-intervention were analyzed and compared between the MBSR and control groups.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eHarms\u003c/h2\u003e \u003cp\u003eDue to the non-pharmacological nature of the intervention, adverse events were not systematically assessed using a standardized reporting form. However, participants were encouraged to report any discomfort or unintended effects during the intervention period. No adverse events were reported by participants.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eStatistical analyses were performed using IBM SPSS Statistics for Windows, Version 25.0. categorical variables were summarized as frequency and percentage, and quantitative variables as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. Descriptive statistics were used to summarize sociodemographic characteristics of the participants. In accordance with CONSORT recommendations, no inferential statistical tests were conducted to compare baseline characteristics between groups. Randomization was expected to ensure baseline comparability between groups. To evaluate the effect of the intervention, between-group comparisons were conducted using analysis of covariance (ANCOVA), adjusting for baseline values. Analyses were performed using post-test scores adjusted for pre-intervention values. Effect sizes were reported using partial eta-squared (η\u0026sup2;). The significance level was set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Analyses of PMS subdimensions were conducted as secondary exploratory analyses to provide a more detailed understanding of symptom changes. No formal correction for multiple comparisons was applied; therefore, these findings should be interpreted with caution.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eProtocol and Statistical Analysis Plan\u003c/h2\u003e \u003cp\u003eThe trial protocol and statistical analysis plan are available from the corresponding author upon reasonable request.\u003c/p\u003e \u003cp\u003e We used the CONSORT reporting guideline and completed the CONSORT checklist to improve the transparency and completeness of trial reporting (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThe study was completed with a total of 126 participants (63 in the MBSR group and 63 in the control group). There were no missing outcome data, and all randomized participants completed the pre-test and post-test assessments. The sociodemographic characteristics of participants in the MBSR and control groups were comparable based on descriptive statistics (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). In accordance with CONSORT recommendations, no inferential statistical tests were conducted to compare baseline characteristics.\u003c/p\u003e \u003cp\u003e\u003cstrong\u003eTable 1.\u003c/strong\u003e Sociodemographic Characteristics of Women with Premenstrual Syndrome\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1.\u003c/strong\u003e Sociodemographic Characteristics of Women with Premenstrual Syndrome\u003c/p\u003e\n\u003cdiv\u003e\n \u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"509\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 228px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCharacteristic\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 141px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMBSR group\u003csup\u003e\u0026nbsp;\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n=63)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 141px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eControl group\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(n=63)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 228px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 141px;\"\u003e\n \u003cp\u003e29.76\u0026plusmn;6.39\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 141px;\"\u003e\n \u003cp\u003e31.19\u0026plusmn;9.32\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 228px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFirst menarche age\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 141px;\"\u003e\n \u003cp\u003e14.42\u0026plusmn;2.63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 141px;\"\u003e\n \u003cp\u003e14.01\u0026plusmn;1.84\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 228px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEducational level\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eHigh school and below\u003c/p\u003e\n \u003cp\u003eUniversity and above\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003cp\u003e53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e15.9\u003c/p\u003e\n \u003cp\u003e84.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003cp\u003e45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e28.6\u003c/p\u003e\n \u003cp\u003e71.4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 228px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMarital status\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eMarried\u003c/p\u003e\n \u003cp\u003eSingle\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e34\u003c/p\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e54.0\u003c/p\u003e\n \u003cp\u003e46.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e32\u003c/p\u003e\n \u003cp\u003e31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e50.8\u003c/p\u003e\n \u003cp\u003e49.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 228px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIncome situation\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eIncome less than expenses\u003c/p\u003e\n \u003cp\u003eIncome equal to expenses\u003c/p\u003e\n \u003cp\u003eIncome greater than expenses\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e16\u003c/p\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e25.4\u003c/p\u003e\n \u003cp\u003e63.5\u003c/p\u003e\n \u003cp\u003e11.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e22\u003c/p\u003e\n \u003cp\u003e33\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e34.9\u003c/p\u003e\n \u003cp\u003e52.4\u003c/p\u003e\n \u003cp\u003e12.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 228px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmployment status\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eEmployed\u003c/p\u003e\n \u003cp\u003eUnemployed\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e43\u003c/p\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e68.3\u003c/p\u003e\n \u003cp\u003e31.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 71px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e37\u003c/p\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003cp\u003e58.7\u003c/p\u003e\n \u003cp\u003e41.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\u003c/br\u003e\u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of Outcome Measures Between the MBSR and Control Groups\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTreatment Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePretest\u003c/p\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePosttest Adjusted Mean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP-Value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePartial Eta\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003ePMSS\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMBSR group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e147.47 (41.66)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e124.01\u003csup\u003ea\u003c/sup\u003e (37.96)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;.001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e.117\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eControl group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e150.65 (34.86)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e145.36\u003csup\u003ea\u003c/sup\u003e (16.95)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCF-PPS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMBSR group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e43.82 (1.47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35.14\u003csup\u003ea\u003c/sup\u003e (1.40)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;.001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e.125\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eControl group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e44.49 (1.48)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e43.39\u003csup\u003ea\u003c/sup\u003e (1.39)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePWBS\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMBSR group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e32.92 (13.05)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44.39\u003csup\u003ea\u003c/sup\u003e (10.14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;.001\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e.285\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eControl group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e34.61 (13.23)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34.38\u003csup\u003ea\u003c/sup\u003e (10.15)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003ePMSS: Premenstrual Syndrome Scale, CF-PPS: The Childbirth Fear - Prior to Pregnancy Scale,\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003ePWBS: Psychological Well-being Scale, SD: Standard Deviation\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003csup\u003ea\u003c/sup\u003e Adjusted post-test means were estimated using ANCOVA controlling for baseline values.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e presents the findings regarding the pre- and post-intervention comparisons of the mean PMSS, CF-PPS, and PWBS scores of women in the MBSR and control groups. The findings show that the MBSR program provided a significant improvement in all variables. PMSS scores, which measure the severity of premenstrual syndrome, decreased from 147.47 to 124.01 in the MBSR group, while there was a limited decrease from 150.65 to 145.36 in the control group; this difference is statistically significant (p \u0026lt; .001) and shows a moderate effect size (η\u0026sup2; = .117). Similarly, the CF-PPS score, which assesses fear of childbirth, decreased from 43.82 to 35.14 in the MBSR group, while only a small decrease was recorded in the control group (from 44.49 to 43.39); this result was also found to be significant (p \u0026lt; .001, η\u0026sup2; = .125). The PWBS score, indicating psychological well-being, significantly increased from 32.92 to 44.39 in the MBSR group, while no improvement was observed in the control group (from 34.61 to 34.38). This increase is statistically significant (p \u0026lt; .001) and shows a relatively large effect size (η\u0026sup2; = .285). Overall, the findings suggest that the MBSR intervention is associated with statistically significant improvements in premenstrual symptoms, fear of childbirth, and psychological well-being.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e illustrates the changes in PMS subdimensions across the study groups from baseline to post-intervention. Descriptively, greater reductions were observed in the MBSR group compared to the control group, particularly in depressive mood, anxiety, irritability, depressive thoughts, pain, and bloating. These analyses were conducted as exploratory, and the findings should be interpreted with caution due to the absence of correction for multiple comparisons. Therefore, these findings should be considered hypothesis-generating rather than confirmatory.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOne of the key contributions of this study is the simultaneous examination of premenstrual symptoms, pre-pregnancy fear of childbirth, and psychological well-being within a single randomized controlled design. This integrated approach extends the existing literature, which has predominantly focused on symptom reduction alone. The interpretation of the findings is based on between-group comparisons adjusted for baseline values, in line with recommended statistical approaches for randomized controlled trials.\u003c/p\u003e \u003cp\u003eThis randomized controlled trial investigated the effects of MBSR on premenstrual symptom severity, prenatal fear of childbirth, and psychological well-being in women experiencing PMS. The findings indicate that the MBSR intervention was associated with statistically significant improvements across all primary and secondary outcomes. The moderate effect sizes observed for PMSS and CF-PPS, together with the near-large effect size for PWBS, suggest that the intervention is associated with improvements of moderate to large magnitude.\u003c/p\u003e \u003cp\u003eThe findings of this study indicate that the MBSR intervention led to a statistically significant reduction in premenstrual symptom severity compared to the control group, based on adjusted between-group comparisons. The observed moderate effect size further supports the effectiveness of the intervention. These findings are consistent with previous studies reporting that mindfulness-based interventions reduce PMS symptoms and associated psychological distress [\u003cspan additionalcitationids=\"CR13\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eExploratory analyses suggested greater improvements in emotional and somatic PMS symptoms in the MBSR group, particularly in depressive mood, anxiety, irritability, depressive thoughts, pain, and bloating. However, as no correction for multiple comparisons was applied, these findings should be interpreted cautiously. This pattern may be explained by the fact that MBSR primarily targets cognitive and emotional regulation processes. Mindfulness practices are known to reduce rumination and stress reactivity while enhancing emotional awareness and self-regulation [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. However, symptoms more strongly influenced by biological and circadian mechanisms, such as sleep and appetite, may require longer-term or multimodal interventions.\u003c/p\u003e \u003cp\u003eSimilarly, a statistically significant reduction in fear of childbirth was observed in the MBSR group compared to the control group. The moderate effect size suggests that the intervention had a meaningful impact on anticipatory childbirth-related concerns. Fear of childbirth is associated with cognitive-emotional processes such as catastrophizing, intolerance of uncertainty, and perceived loss of control. Mindfulness-based interventions may reduce perceived threat by fostering non-judgmental awareness and acceptance of internal experiences. Previous studies conducted with pregnant populations have shown that mindfulness-based programs reduce fear of childbirth and improve psychological outcomes [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. The present findings extend this evidence to the pre-pregnancy period, suggesting a potential preventive role of MBSR.\u003c/p\u003e \u003cp\u003eIn terms of psychological well-being, the findings indicate a statistically significant improvement in the MBSR group compared to the control group, with a relatively large effect size. However, this finding should be interpreted with caution. In particular, the use of self-reported measures and the potential influence of expectancy effects may have contributed to an overestimation of the observed effect. Previous literature has reported that mindfulness-based interventions can produce small to moderate, and in some cases large, improvements in psychological well-being [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Therefore, although the findings are generally consistent with the literature, further studies incorporating objective measures and long-term follow-up are needed to confirm the robustness of these effects.\u003c/p\u003e \u003cp\u003eAnother important consideration is that fear of childbirth was assessed in a non-pregnant population. Therefore, the findings reflect anticipatory perceptions rather than experiences related to actual pregnancy. It is possible that fear levels may differ among women who are actively planning pregnancy compared to those who are not, which was not assessed in the present study. Future research may benefit from considering pregnancy intention as a stratification variable.\u003c/p\u003e \u003cp\u003eOverall, the findings suggest that MBSR may be a useful psychosocial intervention for improving both symptom-related and broader psychological outcomes in women experiencing PMS. However, given the multifactorial nature of PMS, such interventions should be considered as part of a comprehensive approach that may include lifestyle modifications, medical treatment, and long-term behavioral support.\u003c/p\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eThe study has some limitations. First, the intervention effects are based only on short-term (pre-test\u0026ndash;post-test) measurements. The lack of long-term follow-up data limits inferences about the sustainability of the MBSR program's effects. Future studies are recommended to evaluate the medium- and long-term effects of the intervention with follow-up measurements.\u003c/p\u003e \u003cp\u003eSecond, the fact that the intervention was conducted online may have had a limiting effect on group interaction, therapeutic bonding, and application intensity compared to face-to-face applications. Therefore, direct generalization of the findings to face-to-face MBSR programs should be considered with caution.\u003c/p\u003e \u003cp\u003eAnother limitation of this study is the lack of blinding of participants and intervention providers due to the nature of the MBSR program. This may have introduced potential biases such as expectancy effects and reporting bias. In addition, all outcome measures were based on self-reported instruments, which may be subject to social desirability bias.\u003c/p\u003e \u003cp\u003eFurthermore, the absence of an active control group limits the ability to distinguish the specific effects of the MBSR intervention from non-specific factors such as attention and participation effects.\u003c/p\u003e \u003cp\u003eHowever, the use of a randomized controlled design, validated measurement tools, and the reporting of effect sizes strengthens the internal validity of the study and partially mitigates these limitations.\u003c/p\u003e \u003cp\u003eFinally, the fact that the sample consisted of women with PMS severity above a certain threshold (PMSS\u0026thinsp;\u0026ge;\u0026thinsp;110) who voluntarily participated in the study may limit the generalizability of the findings to women with milder PMS symptoms or to different sociocultural contexts.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn conclusion, this study suggests that MBSR may be an effective non-pharmacological approach for reducing premenstrual symptoms, decreasing pre-pregnancy fear of childbirth, and improving psychological well-being in women experiencing PMS.\u003c/p\u003e \u003cp\u003eHowever, given the short-term nature of the assessment and the absence of long-term follow-up data, these findings should be interpreted with caution. MBSR may be considered a promising supportive intervention within women's health services, but further research with longer follow-up periods and diverse populations is needed to confirm its long-term effectiveness and clinical applicability.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAA: Conceptualization, Methodology, Investigation, Data curation, Formal analysis, Writing \u0026ndash; original draft, Writing \u0026ndash; review \u0026amp; editing, Supervision.ESB: Methodology, Investigation, Data curation, Validation, Writing \u0026ndash; review \u0026amp; editing.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data that support the findings of this study are available from the corresponding author upon reasonable request. The data are not publicly available due to ethical restrictions and to protect the privacy and confidentiality of the participants.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eArenliu A, Krasniqi S, Ibrahimi A (2016) Premenstrual syndrome and its impact on daily life. Health Psychol Res 4(2):123\u0026ndash;130. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.4081/hpr.2016.123\u003c/span\u003e\u003cspan address=\"10.4081/hpr.2016.123\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eArı\u0026ouml;z N, Ege E (2013) Premenstrual syndrome: prevalence and severity in Turkish women. 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Delacorte, New York\u003c/span\u003e\u003c/li\u003e\u003c/ol\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":"MBSR, Premenstrual Syndrome, Childbirth Fear, Psychological Well-being","lastPublishedDoi":"10.21203/rs.3.rs-9502810/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9502810/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eAim:\u003c/h2\u003e \u003cp\u003eThis study aimed to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on premenstrual symptom severity, pre-pregnancy fear of childbirth, and psychological well-being in women experiencing Premenstrual Syndrome (PMS).\u003c/p\u003e\u003ch2\u003eMaterials and Methods:\u003c/h2\u003e \u003cp\u003eThis randomized controlled trial was conducted with 126 women experiencing PMS between June 2023 and November 2025 (MBSR group: n\u0026thinsp;=\u0026thinsp;63; control group: n\u0026thinsp;=\u0026thinsp;63). The intervention group participated in an 8-session online MBSR program, delivered twice weekly (40 minutes per session), while the control group received no intervention. Data were collected using the Premenstrual Syndrome Scale (PMSS), the Childbirth Fear \u0026ndash; Prior to Pregnancy Scale (CF-PPS), and the Psychological Well-being Scale (PWBS). Between-group differences were analyzed using analysis of covariance (ANCOVA) adjusting for baseline values, and effect sizes were reported using partial eta-squared (η\u0026sup2;). The trial was retrospectively registered (ClinicalTrials.gov, NCT06942169).\u003c/p\u003e\u003ch2\u003eResults:\u003c/h2\u003e \u003cp\u003eThe MBSR intervention was associated with statistically significant improvements in all outcomes compared to the control group. Adjusted analyses indicated a significant reduction in premenstrual symptom severity (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, η\u0026sup2;=0.117) and fear of childbirth (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, η\u0026sup2;=0.125), as well as a significant increase in psychological well-being (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001, η\u0026sup2;=0.285). These findings correspond to moderate effect sizes for PMSS and CF-PPS and a near-large effect size for PWBS.\u003c/p\u003e\u003ch2\u003eConclusion:\u003c/h2\u003e \u003cp\u003eThe findings suggest that MBSR may be an effective non-pharmacological intervention for reducing premenstrual symptoms, decreasing pre-pregnancy fear of childbirth, and improving psychological well-being in women experiencing PMS. However, the results should be interpreted with caution due to the short-term nature of the assessment and the absence of long-term follow-up data.\u003c/p\u003e","manuscriptTitle":"The Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth and Psychological Well-being in Women Experiencing Premenstrual Syndrome: A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-05-11 16:08:03","doi":"10.21203/rs.3.rs-9502810/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":"145edbfd-a19f-4619-b302-58523170802c","owner":[],"postedDate":"May 11th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Revision requested","date":"2026-05-18T17:18:07+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-18T09:37:56+00:00","index":11,"fulltext":""},{"type":"reviewerAgreed","content":"209782457818248060415733828331509002780","date":"2026-05-05T19:29:49+00:00","index":9,"fulltext":""},{"type":"reviewersInvited","content":"4","date":"2026-05-03T19:04:26+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-05-01T07:30:30+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-18T17:24:03+00:00","versionOfRecord":[],"versionCreatedAt":"2026-05-11 16:08:03","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9502810","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9502810","identity":"rs-9502810","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}