Comparing the effectiveness of two telemedicine counseling interventions on secondary tokophobia in single-child women: the study protocol of a pragmatic three-arm randomized controlled trial.

Background: Identifying women with secondary tokophobia and offering effective counseling can reduce the psychological burden of their negative experience's childbirth. In light of Iran's population incentive policies, this research will compare the effects of two telemedicine-based counseling methods on secondary tokophobia in single-child women.

Methods/design: This study will be conducted in two phases. Phase 1 will identify women with secondary tokophobia through a cross-sectional descriptive study using the Fear of Childbirth Prior to Pregnancy (FOCPP) tool. Phase 2 will be a three-arm randomized controlled trial (RCT), enrolling 102 single-child women with secondary tokophobia, block-randomized in blocks of six to receive either Acceptance and Commitment Therapy (ACT - arm 1), motivational counselling (MC - arm 2), or standard care (control). The study will follow CONSORT-EHEALTH guidelines. Outcomes, including tokophobia, anxiety, depression, and postnatal PTSD, will be assessed at weeks four and eight using standardized questionnaires. Data will be analyzed using statistical tests in SPSS-24.

Discussion: Negative past experiences can lead to secondary tokophobia, where women fear future pregnancies, sometimes avoiding them altogether. Research shows that those with tokophobia may face anxiety, depression, and PTSD, necessitating counseling to encourage future pregnancies. This study will be aim to investigate two counseling interventions for single-child women with secondary tokophobia through a telemedicine approach in the context of Iranian population policies.

Trial registration: Current Controlled Trials IRCT20240207060923N1. Registered 18 May 2024.