The effect of mindfulness-based couple-centered intervention in parents following fetal abnormalities requiring pregnancy termination: study protocol for a randomized controlled trial

正念式夫妻干预对因胎儿异常而终止妊娠的父母的影响:一项随机对照试验的研究方案

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Abstract

BACKGROUND: Termination of pregnancy for fetal abnormalities (TOPFA) represents a significant global healthcare challenge. In China, the occurrence of fetal abnormalities is notably high. TOPFA is a devastating traumatic event for parents and families. Parents frequently encounter psychological issues and negative emotions such as depression, anxiety, prolonged grief, feelings of inadequacy, persistent guilt, and symptoms of post-traumatic stress disorder (PTSD). METHODS/DESIGN: This prospective, randomized controlled trial aims to assess the feasibility and impact of a mindfulness-based, couple-centered intervention (MBCI) on anxiety, depression, mindfulness level, and family support among bereaved parents. The study will enroll 124 couples experiencing TOPFA. Participants will be randomly assigned to either the intervention group (receiving MBCI in addition to routine psychological care) or the control group (receiving only routine psychological care). Data will be collected at three time points: baseline, post-intervention and 42 days postpartum. Additionally, participants are expected to complete a weekly mindfulness exercise feedback form. Semi-structured, in-depth interviews with the intervention group will be conducted post-intervention and 42 days postpartum. DISCUSSION: This RCT aims to investigate the effectiveness of a couple-centered mindfulness intervention on the psychological well-being of parents experiencing TOPFA. If effective, this intervention could serve as a complement to routine psychological care, aiding in the physical and mental recovery of women and their families.

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