Effectiveness of the virtual group counselling based on health literacy on empowerment and self-care of Iranian pregnant women: a study protocol for an exploratory parallel group randomised controlled trial.

Abstract

Enhancing empowerment and self-care practices during pregnancy reduces complications for women during this critical period. Health literacy stands as a crucial component in empowering pregnant women. Without a sufficient grasp of healthcare information, making informed decisions and choices for desired health outcomes becomes challenging. This study will assess the effectiveness of virtual group counselling based on health literacy in enhancing empowerment and self-care among pregnant women. This randomised controlled trial will be conducted in parallel groups on 84 pregnant women. Eligible participants will be randomly assigned to either the control or intervention group using a permuted-block-randomised allocation method with four blocks. The intervention group will engage in five structured online sessions, lasting 30-40 min with 5-8 participants. The study's primary endpoints are the empowerment and self-care of pregnant women, which will be assessed using questionnaires administered before and 1 month after the intervention. The study is planned to start on 20 April 2024 and end on 22 September 2024. The primary outcome analysis will use analysis of covariance (ANCOVA or multivariate ANCOVA), with preintervention scores entered as covariates and the intervention group as a fixed factor. The Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1402.202) approved this protocol. The study findings will be disseminated through peer-reviewed journal publication and scientific conferences. This trial is prospectively registered on 4 April 2024 at the Iranian Registry of Clinical Trials (IRCT20221109056451N1).