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

NCT07787000 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2026-08-26

No results posted yet for this study

Summary

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.

Conditions

  • Perinatal Anxiety

Interventions

BEHAVIORAL

Arm 2: BreLax Intervention Group 1

* 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

BEHAVIORAL

Arm 3: Combined Intervention Group 3

* 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

Sponsors & Collaborators

  • Bahria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-08-31
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787000 on ClinicalTrials.gov