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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

bmjopen · 2026-06-17 · canonical JSON source

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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.