Peer-reviewed article
Effect of systemic counselling on anxiety and childbirth self-efficacy among first-time mothers: a randomised controlled trial protocol in prenatal healthcare centres of Babol, Iran.
Movaddt A, Mohsenzadeh-Ledari F, Omidvar S, Adib Rad H, Pasha H et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a protocol for a randomised controlled trial testing systemic counselling to reduce anxiety and improve childbirth confidence among first-time pregnant women in Iran. The study will involve 72 women receiving six group counselling sessions delivered mostly online, using a family-focused approach. The trial aims to measure anxiety levels, childbirth self-efficacy, and satisfaction with the birth experience.
Key points
- The intervention consists of six 90-minute systemic counselling sessions, one in-person and five online via WhatsApp, delivered to groups of 6-10 first-time mothers
- The study uses Bowen systemic counselling approach targeting family and social dynamics
- Primary outcomes are anxiety reduction, enhanced childbirth self-efficacy and improved satisfaction with childbirth
- Sample size is 72 primiparous women randomly assigned to intervention or control group
- Trial is ongoing with enrolment beginning November 2025 and expected completion by July 2026
Limitations
This is a protocol document, not results, so no evidence of effectiveness is yet available. The study has not yet completed data collection or analysis, limiting any conclusions about the intervention's impact.
Abstract
Introduction Pregnancy and childbirth are transformative experiences that can provoke anxiety, potentially reducing women's confidence and satisfaction with the process. Systemic counselling, which considers family and interpersonal dynamics, may alleviate anxiety, enhance self-efficacy and improve satisfaction with childbirth. Addressing these psychological and relational factors is crucial for maternal and neonatal well-being. Methods and analysis This parallel-group randomised controlled trial will involve 72 primiparous pregnant women in Babol, Iran. Eligible participants will be randomly assigned to either the intervention or control group using permuted block randomisation with a block size of four. The intervention group will receive six structured 90-minute sessions, including one in-person and five online group sessions (6-10 participants per session) delivered via WhatsApp. The sessions follow a Bowen systemic counselling approach targeting family and social dynamics. The primary outcomes are anxiety reduction, enhanced childbirth self-efficacy and improved satisfaction with childbirth. The target sample size is 72 participants (36 per group). Participant enrolment began in November 2025 and is currently ongoing. Data will be analysed using both the full analysis set (FAS) and per-protocol set (PPS). The trial is currently ongoing and is expected to be completed by July 2026. Ethics and dissemination The study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.070). The sponsor is Babol University of Medical Sciences. No external funding was received. Results will be disseminated through peer-reviewed journals and scientific conferences. Trial registration IRCT20100510003902N7.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Systemic counselling using Bowen approach delivered through six group sessions (one in-person, five online via WhatsApp) targeting family and interpersonal dynamics
- Population
- Primiparous (first-time) pregnant women in Babol, Iran
Key finding
Study is at protocol stage; no results yet available as enrolment began November 2025 with completion expected July 2026