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.
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 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
Parallel
Arm 2: BreLax Intervention Group 1
Behavioral* 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 3
Behavioral* 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
Perinatal Anxiety & Self-efficacy
Pregnancy-Related Anxiety Questionnaire (PRAQ-R2): Evaluates pregnancy-specific anxieties and fear of childbirth.
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.
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.
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