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

NCT07787000 | Not Yet Recruiting DMC

• 1 other identifier: 00009
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Perinatal anxiety; BreLax intervention; antenatal education; self-efficacy; maternal health outcomes; slum population; randomized controlled trial; COM-B model

Outcome Measures

Primary Outcomes (1)

• Perinatal Anxiety & Self-efficacy

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

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

Secondary Outcomes (2)

• Childbirth Experience

  immediately after completion of the intervention sessions (T1), two to four weeks after birth (T3).

• Sociodemographic & Contextual

  Enrolment, Baseline & before the intervention

Study Arms (3)

Arm 1: Control Group

NO INTERVENTION

Receive routine antenatal care and advice during ANC visits

Arm 2: BreLax Intervention Group 1

ACTIVE COMPARATOR

* 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 2: BreLax Intervention Group 1

Arm 3: Combined Intervention Group 2

EXPERIMENTAL

* 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

Behavioral: Arm 3: Combined Intervention Group 3

Interventions

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 2: BreLax Intervention Group 1

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

Arm 3: Combined Intervention Group 2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• women with a history of intrauterine death or stillbirths will be considered

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahria University: lead

Central Study Contacts

Hina Ms Sharif, MSPH

CONTACT

03373305666; hina.shf19@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: 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

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08