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临床试验/NCT07787000
NCT07787000尚未招募不适用

Evaluating Antenatal Bre-Lax Education for Perinatal Anxiety Reduction and Self-efficacy Among Pregnant Women in Karachi's Urban Slums: A Prospective, Randomized, Open-label, Blind Endpoint (PROBE) Trial

Bahria University0 个研究点目标入组 255 人开始时间: 2026年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
255
主要终点
Perinatal Anxiety & Self-efficacy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

A Prospective, Randomized, Open-label, Blind Endpoint (PROBE) Trial,• Participants and trainer cannot be blinded due to behavioral intervention

• Outcome assessors and Biostatistician will be blinded to group allocation to reduce bias

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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
  • willing to participate by providing informed consent will be eligible for inclusion
  • women with a history of intrauterine death or stillbirths will be considered

排除标准

  • 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
  • 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
  • women who screen positive on the Fear of Birth Scale will also be excluded from participation

结局指标

主要结局

Perinatal Anxiety & Self-efficacy

时间窗: baseline (T0), two to four weeks after birth (T3).

Pregnancy-Related Anxiety Questionnaire (PRAQ-R2): Evaluates pregnancy-specific anxieties and fear of childbirth.

次要结局

  • Childbirth Experience(immediately after completion of the intervention sessions (T1), two to four weeks after birth (T3).)
  • Sociodemographic & Contextual(Enrolment, Baseline & before the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hina Sharif

Senior Lecturer

Bahria University

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