The effect of mindfulness-based couple-centered intervention in parents following fetal abnormalities requiring pregnancy termination: study protocol for a randomized controlled trial.
Shiwen Sun, Jialu Qian, Yaping Sun, Chunxiao Hu, Xiaojuan Zeng, Ju Ma, Ying Yao, Kaiying Wang, Xiaoyan Yu
BMC Pregnancy and Childbirth October 2, 2025 DOI: 10.1186/s12884-025-08138-2 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (study protocol) Peer reviewed |
|---|---|
| Sample size | 124 |
| Population | Couples in China who have terminated a pregnancy for fetal abnormalities |
| Intervention | routine psychological care |
| Duration | Data collected at baseline, post-intervention, and 42 days postpartum |
| Topics | Anxiety Depression Meditation |
| Keywords | Humans Abortion, induced Prospective studies Feasibility studies Parents Stress disorders, post-traumatic Pregnancy Adult China Female Family support |
| Key findings | The protocol proposes testing whether a mindfulness-based, couple-centered intervention improves anxiety, depression, mindfulness level, and family support among parents who terminate a pregnancy for fetal abnormalities, compared with routine psychological care alone. The authors suggest that, if effective, the intervention could complement routine psychological care and aid the recovery of women and their families. |
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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |