Antenatal Bre-Lax Education for Perinatal Anxiety Reduction and Self-efficacy Among Pregnant Women in Karachi's Urban Slums

Overview

Background Pregnant women in urban slums experience heightened stress and anxiety due to poor living conditions, limited healthcare access, and weak social support systems. High levels of perinatal anxiety are associated with adverse maternal and neonatal outcomes, including negative childbirth experiences. Evidence-based interventions such as structured antenatal education and relaxation techniques have shown benefits in other populations but remain underutilized in slum communities. The BreLax intervention, combining breathing and relaxation exercises with culturally adapted educational materials, offers a feasible, low-cost approach to address this gap Methods This study will be conducted as a double-blinded randomized controlled trial (RCT) with four parallel arms: (1) routine antenatal care (control), (2) antenatal care plus structured education, (3) antenatal care plus BreLax breathing and relaxation technique, and (4) antenatal care plus combined BreLax and structured education. Eligible participants will be randomly assigned using computer-generated sequences with allocation concealment. Data will be collected at four time points: baseline (T0), post-intervention (T1), late third trimester/early postpartum (T2), and two to four weeks after birth (T3). Outcomes The primary outcome is reduction in perinatal anxiety measured by the Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2). Secondary outcomes include childbirth experiences assessed by the Questionnaire for Assessing Childbirth Experience (QACE) and associations between socio-demographic factors and maternal outcomes. Analysis Data will be analyzed using SPSS. Descriptive statistics will summarize baseline characteristics, while repeated measures ANOVA and regression models will compare intervention effects across groups and time points. Hypothesis testing will be conducted at a 95% confidence level.

Introduction: Pakistan is ranked fifth among the most populous countries with a total population of around 260 million in spite of a 77 years long history of family planning programs in the country. The year 2015 was the culminating year of the Millennium Development Goals (MDGs) for Pakistan as well as in other countries, yet the indicators for achieving MDGs 4 (reduce child mortality) and 5 (improve maternal health) have remained unfavorable. Moreover, the current sustainable development's goal (SDGs) has added additional responsibility on the country to improve indicators on population control in addition to the FP2030 vision and commitments. Pregnancy is a significant milestone in a woman's life, bringing joy and expectation. However, it also comes with some challenges, as the body undergoes physical changes while emotional and psychological changes arise within the women. Despite all these changes, pregnancy is a transformative journey that prepares women for motherhood, making it both a beautiful and demanding experience . However, with the passage of time, there is rising recognition that pregnancy can also bring psychological challenges within the women. Women are increasingly seen as vulnerable towards the mental health issues like anxiety and depression. Acknowledging these challenges is crucial to providing the necessary support and care for pregnant women during this transformative period. It is seen that Depression and Anxiety are considering as common mental health issues during pregnancy, but recent research suggests that anxiety may be even more prevalent than depression. Emerging evidence indicates that expectant mothers are more likely to experience anxiety, highlighting the need for support for maternal mental health. Pregnancy related anxiety is not only associated with the expected mother but also has a great influence on the prenatal environment. According to the Fetal Programming Hypothesis, a developing fetus is highly sensitive to its environment, especially during rapid growth stages. Factors like maternal anxiety can lead to physiological changes that affect the fetus critically. If these influences occur during crucial developmental stages, they may cause long-lasting effects in the baby's physical health and as well as in metabolism. Essentially, the conditions in the womb shape long-term health outcomes. This means that stress and other environmental factors during pregnancy don't just impact the mother but they can have lifelong effects on the child's body and as well as on its functions. Pregnancy-related anxiety is strongly linked to various negative health outcomes for both the mother and baby. Studies consistently shows that high levels of anxiety during pregnancy can increase the risk of preterm birth, leading to possible complications for the newborn baby. It is seen that women are more vulnerable toward mental health disorders like Anxiety and Depression during the time period of prenatal period, which is closely associated with the health of the pregnant women and as well as the children. Children born to mothers who experience significant anxiety may face developmental delays as they grow. Anxiety can also negatively impact the childbirth process, contributing to prolonged labor and increasing the need for pain relief or sedation during delivery. These highlight the crucial role of maternal mental health in pregnancy. When a mother experiences high stress or anxiety, it can affect both the course of labor and the baby's early development. Understanding and addressing pregnancy-related anxiety is essential to improving birth outcomes and promoting healthier development in children. There are many factors which are associated with the Anxiety among pregnant women, which includes socio-economic factors, demographic factors and environmental factors. Adverse childhood experiences are one of the major factors associated with the Anxiety among pregnant women. Childhood neglect, abusive or harsh parental behavior, and gender-based discrimination at an early age can have a profound psychological impact, leading to mental health disturbances such as anxiety and stress during pregnancy. Women who have experienced Adverse Childhood Experiences ACEs are more vulnerable to psychological disorders, including anxiety, depression, and post-traumatic stress during this critical period. It has been seen that those women who faced adverse childhood experience are more vulnerable towards the psychological disorders like Anxiety, Depression and Traumatic stress during the pregnancy. Due to these mental health disturbance in the duration of the pregnancy, the risk of the tobacco consumption like cigarette and chewable tobacco increases in women and they start intaking such things for mental relaxation but it results in increasing Anxiety and Psychological disorder and also has a bad impact on fetus. Poverty is one of the important factors which impacts the mental health of pregnant women significantly. Financial struggles, such as unemployment, household responsibilities, housing issues, and rising food expenses, create constant stress to the human mind. The increasing cost of daily necessities adds to their burden, making it difficult to manage basic needs while preparing for a child. These challenges heighten anxiety among the pregnant women, who is conscious about providing a stable environment and the basic life needs to their baby. The pressure of balancing financial insecurity with physical and emotional well-being can be overwhelming and play a vital part in increasing the risk of high psychological issues during pregnancy. Low income can negatively impact the nutrition and care of an unborn baby which can be a reason for increasing Anxiety among pregnant women. Expecting mothers may struggle financially, facing challenges in affording medical care and maintaining their child's well-being. The cost of prenatal checkups, proper nutrition, and future child-rearing expenses can add significant stress and Anxiety . Early marriages play a vital role in psychological disorder like Anxiety and depression among pregnancy. Adolescent mothers whose age between 11 to 19 years often experience significant anxiety as they navigate pregnancy, childbirth, and parenting in very early time period of their life . The overwhelming responsibility can lead to fear of unpreparedness, regret, shame, and emotional distress among them. Many struggles with depression, guilt, loneliness, and social isolation, while also facing strained relationships. The mental exhaustion from these challenges can deeply impact their well-being, making motherhood a stressful and anxiety-inducing experience at a young age . Domestic violence is recognized as one of the biggest sources of the psychological disturbance in the time period of pregnancy. The World Health Organization (WHO) declared domestic violence as violent and a gender-based behavior which causes emotional, physical, sexual, and psychological damage to the women . Pregnancy itself has a great impact on the physical and psychological health of women, when it emerged with the other factor like violence it results in the adverse impact on the women's health which effects the health of the mother and the child as well . Domestic violence during pregnancy is a serious issue that significantly affects a woman's quality of life especially affecting women's mental health. Research on this topic is increasing worldwide, highlighting its impact on both developed and developing countries. Experiencing violence while pregnant poses severe risks to both the mother and fetus, leading to heightened anxiety, emotional distress, and physical harm. The fear, stress, and trauma associated with domestic violence can severely impact maternal mental health, making it a critical public health concern . Pregnant women living in urban slums face unique challenges that differ significantly from those in more resource-rich settings. Limited access to healthcare, poor living conditions, financial insecurity, and low literacy levels all contribute to heightened stress and anxiety during pregnancy. Unlike populations where structured antenatal education, psychosocial support, and relaxation interventions are commonly available, women in slum communities often lack such opportunities. This absence of supportive interventions leaves them vulnerable to unmanaged anxiety, negative perceptions of childbirth, and poor maternal outcomes . Social support is widely recognized as a buffer against pregnancy-related stress and anxiety. In slum populations, many women lack robust support from spouses, families, and peers. This absence of emotional and practical assistance heightens their risk of isolation and depression and erodes their confidence in navigating pregnancy and childbirth. Interventions such as structured antenatal education and breathing or relaxation techniques, shown to be effective in other groups, remain largely untested in these marginalized communities. This study aims to assess whether structured breathing and relaxation techniques with antenatal education can reduce perinatal anxiety and enhance childbirth experiences in slum populations, where such strategies have not yet been adopted. This research will provide evidence on the value of low-cost, culturally adapted interventions in underserved communities, supporting better maternal mental health and promoting safer, more positive birth outcomes. Aim of the Study The aim of this study is to evaluate the effectiveness of the BreLax breathing and relaxation technique and structured antenatal education, individually and in combination, in reducing perinatal anxiety and enhancing childbirth experiences among pregnant women living in the slums of Karachi. Objectives of the Study Primary Objective Objective To determine whether the combined intervention of BreLax and structured antenatal education produces a greater reduction in perinatal anxiety Hypothesis: * H₀₁ (Null): The combined intervention does not significantly reduce perinatal anxiety compared to routine antenatal care. * H₁₁ (Alternative): The combined intervention significantly reduces perinatal anxiety compared to routine antenatal care Secondary Objectives Objective 1 To assess the independent effect of structured antenatal education on perinatal anxiety levels compared to routine care. Hypothesis: * H₀1: Structured antenatal education has no significant effect on perinatal anxiety compared to routine care. * H₁1: Structured antenatal education significantly reduces perinatal anxiety compared to routine care.. Objective 2 To evaluate the independent effect of the BreLax technique on perinatal anxiety levels compared to routine care. Hypothesis: * H₀2: The BreLax technique has no significant effect on perinatal anxiety compared to routine care. * H₁2: The BreLax technique significantly reduces perinatal anxiety compared to routine care. Objective 3 To compare the relative effectiveness of the combined intervention versus each individual intervention in reducing anxiety scores. Hypothesis: * H₀3: There is no significant difference in anxiety reduction between the combined intervention and the individual interventions. * H₁3: The combined intervention results in a significantly greater reduction in anxiety compared to the individual interventions. Objective 4 To examine differences in childbirth experiences across all study groups, using the QACE, to identify whether interventions contribute to more positive maternal perceptions of birth Hypothesis: * H₀4: There is no significant difference in childbirth experiences among the four study groups. * H₁4: There is a significant difference in childbirth experiences among the four study groups. Study Methodology Study Design: This study will be conducted as a population-based Prospective Randomized Open, Blinded End-point (PROBE) design with three parallel arms. The control group will receive routine antenatal care, which includes general advice and information on pregnancy but excludes structured education or formal training in breathing and relaxation techniques. The one intervention group will receive routine antenatal care along with guided sessions in the BreLax breathing and relaxation technique. However, the intervention group will receive a combination of both structured antenatal education and BreLax sessions in addition to routine care. Eligible participants will be randomly assigned to one of the four study arms using a computer-generated randomization sequence with allocation concealment through sealed opaque envelopes. Double blinding will be ensured by keeping both biostatistician and outcome assessors unaware of group allocation; participants will not be informed of the specific intervention type beyond routine care, and outcome assessors, including biostatisticians, will remain blinded during data analysis. Data will be collected at multiple time points: baseline before the intervention (T0), immediately after completion of the intervention sessions (T1), and in the late third trimester or early postpartum period (T2). Childbirth experience data will also be captured using the Questionnaire Adverse Childhood Experienc (QACE) within two to four weeks after delivery (T3). This repeated-measures design allows for evaluation of both short-term and longer-term effects of the interventions on maternal anxiety and childbirth experiences, while maintaining methodological rigor through randomization and blinding. Study Site: The study will be conducted at the primary health care based antenatal care units located at slums of Karachi Pakistan, of Karachi Participants and Eligibility Criteria: Pregnant women aged between 18 and 40 years, with a gestational age of 12 to 28 weeks at recruitment, residing in selected slum areas of Karachi, and willing to participate by providing informed consent will be eligible for inclusion. Participants must screen positive for mild to moderate anxiety using a validated tool such as Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-2), and women with a history of intrauterine death or stillbirths will be considered. Women will be excluded if they have a diagnosed psychiatric illness requiring medical treatment, high-risk pregnancy complications such as pre-eclampsia or severe anemia, or if they are already practicing structured relaxation techniques or psychological interventions. Those unable to communicate in Urdu or the local language, women with recurrent pregnancy loss, those already on antipsychotic or anti-anxiety medications, and women who screen positive on the Fear of Birth Scale will also be excluded from participation. This approach ensures that the study focuses on women most likely to benefit from the intervention while safeguarding those for whom participation may pose additional risks. Study Arms / Intervention Groups Arm 1: Control Group * Receive routine antenatal care and advice during ANC visits Arm 2: BreLax Intervention Group * Routine antenatal care * BreLax Exercise sessions during four ANC visits * Includes: * Deep breathing techniques ("breath in-breath out") * Progressive muscle relaxation * Guided relaxation practice * Each session approximately 15-20 minutes Arm 3: Combined Intervention Group * Routine antenatal care * Structured educational guidance by a midwife * BreLax exercise during ANC visits * Combination delivered over four visits, Each session approximately 15-20 minutes Intervention Duration * Total duration: 8-12 weeks * Four structured sessions aligned with routine ANC visits Table 1: SPIRIT schedule for enrollment, allocation, and post-allocation. TIMEPOINT Study Period Enrolment, Baseline \& before the intervention immediately after completion of the intervention sessions (T1) late third trimester or early postpartum period (T2) two to four weeks after delivery T0 T1 T2 T3 ENROLMENT: Eligibility screen X Informed consent X Allocation X INTERVENTIONS: Combined Group (BreLax + Antenatal Ed) X X X X Individual Group A (BreLax Only) X X X X Control Group (Routine Antenatal Care) X X X X ASSESSMENTS: Sociodemographic \& Contextual Factors X Primary Outcome: Perinatal Anxiety (PRAQ-R2) X X Secondary Outcomes: Childbirth Experience (QACE) X X Data Collection Procedure 1. Baseline assessment: * Demographic data * Obstetric history * Baseline anxiety score 2. Follow-up assessments: * After completion of intervention (post 4 visits) * Possibly at third trimester or pre-delivery 3. Data will be collected using structured questionnaires administered by trained data collectors Blinding * Participants and trainer cannot be blinded due to behavioral intervention * Outcome assessors and Biostatistician will be blinded to group allocation to reduce bias Sample Size: The study will be conducted as a PROBE randomized controlled trial with three parallel arms. The minimum clinically relevant difference in perinatal anxiety scores to be detected between the intervention and control groups is set at approximately 5 points, based on prior literature. The estimated standard deviation for perinatal anxiety scores is expected to 8 points from baseline. The significance level (α) is fixed at 0.05 for two-tailed testing, and the statistical power (1 - β) is set at 0.80, ensuring an 80% probability of detecting a true effect if present. Participants will be allocated equally across the four arms, following a 1:1:1 ratio. Based on these assumptions, the total sample size required for the study is approximately 200 participants . This number will be distributed evenly across the four arms, resulting in about 68 participants with 20% attrition rate, final 85 per arm and 255 in total. This allocation is expected to provide sufficient statistical power to detect meaningful differences in perinatal anxiety reduction and childbirth experiences between the control arm and the three intervention arms. Randomization: Participants in this study will be randomly allocated into one of the four study arms to ensure comparability and reduce selection bias. The study biostatistician, using block randomization to maintain equal group sizes, will prepare a computer-generated randomization list in advance. Allocation concealment will be achieved through sealed, opaque envelopes that will only be opened at the time of enrollment. This process ensures that neither the participants nor the enrolling staff can predict group assignment. Randomization will be stratified by gestational age (10-16 weeks and 17-24 weeks) to balance potential differences in baseline anxiety levels across groups. By employing this method, the study will maintain methodological rigor and enhance the validity of comparisons between the control, educational intervention, BreLax intervention, and combined intervention groups. Intervention: The complex intervention developed by Leutenegger V et al. (2024) and is grounded in Bandura's self-efficacy theory shown in figure:1. As per Bandura 25, self-efficacy refers to an individual's belief in their ability to perform a specific behavior in a given context. It consists of two key components: outcome expectation and self-efficacy expectation. Outcome expectation relates to an individual's anticipation of the potential consequences of a behavior, if a person believes a particular action will produce a desired result, they are more likely to engage in it. Self-efficacy is shaped and achieved by four primary sources: personal performance, observational learning (vicarious experience), verbal encouragement, and physiological or emotional states 24 As a structured breathing and relaxation program integrated into antenatal education, with the goal of reducing perinatal anxiety and enhancing maternal confidence during pregnancy and childbirth. It combines supervised practice, culturally adapted educational materials, and home-based reinforcement to ensure both short-term and sustained benefits for women living in the slums of Karachi. Self-Efficacy Theory The intervention is grounded in Bandura's self-efficacy theory, which emphasizes that an individual's belief in their ability to perform a specific behavior strongly influences whether they engage in it. Self-efficacy consists of two components: outcome expectation (belief that a behavior will lead to a desired result) and self-efficacy expectation (belief in one's own ability to perform the behavior). Four sources shape self-efficacy: personal performance, vicarious experience, verbal encouragement, and regulation of emotional/physiological states. COM-B Model for Behavior Change The intervention also incorporates the COM-B model, which identifies capability, opportunity, and motivation as essential components for behavior change. * Capability: Women will develop psychological and physical capability by learning correct breathing patterns, relaxation postures, and understanding the rationale behind the techniques. Educational materials will be adapted to their literacy levels, and healthcare providers will guide them systematically. * Opportunity: Social and physical opportunities will be created through live demonstrations, corrections by trained midwives, and provision of pictorial infographics with clear instructions. The supportive environment of antenatal sessions will encourage adoption of the techniques. * Motivation: Reflective motivation will be fostered by highlighting the benefits of BreLax for reducing anxiety and improving birth experiences, while automatic motivation will be reinforced through repeated practice until the techniques become habitual. In the BreLax program, women will gain confidence by successfully practicing breathing and relaxation techniques, observing peers performing the same exercises, receiving supportive feedback from midwives, and experiencing reduced stress and emotional arousal. Visual infographics in Urdu, combined with practical demonstrations, will reinforce these skills and empower women to continue practicing at home. Figures 1 and 2 illustrate the conceptual framework and infographic-based reinforcement of self-efficacy in maternal health outcomes. Figure:1 Conceptual framework of the BreLax intervention impact on maternal health outcom Figure 2 also represented the self-efficacy theory through pictorial info graph. The info graph represents that through picture and guidance in urdu language, mother become self-efficacious towards the change and by empowering them through guidance in form of practical as well as educational pamphlet, pregnant mother will feel relax and stress free during their pregnancy. Women are likely to effectively execute breathing and relaxation methods and see that other women can do these techniques as well. They will also obtain supportive remarks from qualified personnel and midwives. Utilizing the visual infographic or practical instructions on breathing and relaxation techniques provided by experienced personnel, women will be encouraged to persist in their practice at home. Participants will get guidance through the exercises from experienced personnel or via graphical infographics, and they will be encouraged to continue practicing at each visit. COM-B Model for Behavior Change among Women Using BreLax Exercise Technique The intervention was developed to empower and develop self-efficacy of the pregnant women at slums. In order to achieve desire outcomes, COM-B model will be used for behavior change among participants. There are three important components of COM-B model: i. capability, ii. Opportunity, iii. Motivation. The model is preciously design and shown in figure:2. In the model, woman participants develop their Capability through Physically \& Psychologically for their behavior change which includes the real understanding towards the intervention and acquired correct posture and movement appropriately. Additionally, intervention must be designed to ensure clarity of message with their level of literacy and also healthcare provider will guide them before handing over it. Additionally, opportunities encompass both physical and social supports for pregnant women, such as live demonstrations with feedback, pictorial infographics with clear explanations provided in advance, encouragement from designated healthcare staff, trained midwives for this intervention, and in-person training sessions. These resources and opportunities foster both reflective and automatic motivation, empowering women to recognize the benefits of adopting this technique and to integrate it habitually into their daily routines Figure:3 COM-B Model for Behavior Change among pregnant women, lead to reduction in perinatal anxiety. Intervention Delivery BreLax sessions will be delivered during routine antenatal visits, lasting approximately 30-45 minutes. Women will be taught deep breathing techniques emphasizing prolonged exhalation, progressive muscle relaxation, and guided relaxation in various positions (standing, sitting, four-foot, and lateral). Each participant will receive Urdu-language manuals and infographic materials, along with access to short audio or video instructions to support independent practice at home two to three times per week. Midwives and healthcare staff will undergo structured training workshops to ensure fidelity in delivering the intervention. They will provide verbal encouragement, correct posture and breathing during sessions, and motivate women to continue practice outside the clinic. The intervention is designed to become habitual, enabling women to recall and apply the techniques during labour and stressful situations. Data Collection Tool: There are three parts of data collection tool, which are as follows 1. Socio-demographic Scale (Age, Weeks of Pregnancy, ethnic status, Education level, Parity status) 2. The Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) will be used to assess perinatal anxiety. This instrument consists of 10 items grouped into three subscales: fear of giving birth (3 items), worries about bearing a handicapped child (4 items), and concern about appearance (3 items). Each item is rated on a 5-point Likert scale ranging from 1 ("definitely not true") to 5 ("definitely true"), allowing for straightforward responses and quantifiable measurement of anxiety levels across different domains. 3. The Questionnaire for Assessing Childbirth Experience (QACE) will be used to evaluate women's perceptions of their childbirth experience. This self-report instrument is available in French, includes a validated English translation, and has been used in both research and clinical practice. For this study, the 13-item short version will be used, covering four subscales that measure different dimensions of the childbirth experience. Responses will be recorded on a 4-point Likert scale, and results will be dichotomized into "totally" versus "in part, not so much, not at all," with scores allocated accordingly. Higher scores indicate a more negative birth experience, while a score below 19 reflects a positive childbirth experience. Supplementary Figure 3 depicts the study flow, enrollment to allocation and then analysis in the study. Outcome Measures: The primary outcome of the trial is self-efficacy. Further relevant maternal and neonatal outcomes is summarized in Table 1, including the time points at which the measures will be taken. Trained data collectors at each time point will administer all questionnaire to participants. Table-1: Outcomes measures and time points Variables Measures Time points Primary Outcome Perinatal Anxiety \& Self-efficacy Pregnancy-Related Anxiety Questionnaire (PRAQ-R2): Evaluates pregnancy-specific anxieties and fear of childbirth. T0, T3 Secondary Outcomes Childbirth Experience Childbirth Experience Questionnaire QACE: Quantifies the 13-item short version will be used, covering four subscales that measure different dimensions of the childbirth experience. Responses will be recorded on a 4-point Likert scale. T1, T3 Sociodemographic \& Contextual Baseline Profile: Age, nationality/ethnicity, living arrangements within the Karachi slum settings, educational attainment, employment status, monthly family income, baseline gestational age, parity, prior obstetric history, medical history, and pre-existing birth preparation. T0 Statistical Analysis: The data will be analyzed using Stata version 17. Descriptive statistics will be used to summarize baseline characteristics, with categorical variables presented as frequencies and percentages, and continuous variables reported as means and standard deviations. Normality of the outcome variable (scores) will be assessed using the Shapiro-Wilk test separately for pre- and post-intervention measurements in both the intervention and control groups, as well as for the combined pre- and post-intervention scores. The continuous variable results between the control and intervention groups will be evaluated using paired sample t-tests and will be used to assess mean differences between the control and intervention groups from baseline. A repeated measures ANOVA will be conducted to evaluate the effect of group (intervention vs. control), time (pre- and post-intervention), and their interaction on the outcome scores. The analysis will include 160 participants with measurements at multiple time points. Group will be considered a between-subject factor, and time will be a within-subject factor. Partial eta-squared values will be calculated to assess the magnitude of the effects. The model fit will be assessed using R-squared and adjusted R-squared values. The between-subjects error term accounted for by the variable "id/group" will have 160 levels, with pooled covariance over groups. The assumption of sphericity will be checked using the Huynh-Feldt correction, and no further correction will be necessary (epsilon = 1.0000). Post hoc pairwise comparisons will be performed using the Bonferroni correction to control for multiple comparisons, ensuring that the reported p-values account for the increased likelihood of Type I errors. Data Management and Data Monitoring Data collection will be carried out by the principal investigator and trained research assistants using structured questionnaires. All data will be entered directly into a secure, password-protected electronic database designed specifically for research studies. Each participant will be assigned a unique trial identification number, and no personally identifiable information will be stored within the database. Data entry will include built-in validation checks to identify invalid trial numbers, out-of-range values, or mismatched follow-up identifiers, which will be excluded to maintain data integrity. Access to the database will be restricted to authorized members of the research team, with permissions assigned by the investigator to ensure confidentiality and security. Given the short timeframe of the study and the minimal risks anticipated for participants, a formal data monitoring committee will not be established. Instead, the research team will oversee ongoing monitoring of data quality, completeness, and participant safety throughout the study. Any unexpected adverse events or ethical concerns will be promptly reported to the Institutional Review Board, and the need for a formal monitoring committee will be reassessed if circumstances change. This approach ensures that data are managed responsibly and monitored continuously while maintaining efficiency and ethical compliance.