Group Mindfulness Intervention for Negative Emotions in Pregnant Women and Its Effect on Attentional Bias to Pain Cues
| Registry | NCT07757243 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 356 (Actual) |
| Sponsor | Shenzhen Kangning Hospital (Other); collaborators: Shenzhen Luohu District Maternal and Child Health Hospital |
| Conditions | Perinatal Anxiety |
| Interventions | Group Mindfulness Intervention, Group Discussion, Routine Health Education (Behavioral) |
| Dates | start 2021-09-21, primary completion 2022-10-01, completion 2022-10-01, first posted 2026-08-11, last updated 2026-09-11 |
| Locations | 1 site in China |
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This randomized controlled intervention study evaluated an 8-week group mindfulness intervention for pregnant women at 20 to 30 gestational weeks. Participants were randomized to mindfulness-based group intervention, group discussion, or health education. The study assessed anxiety, depressive symptoms, and fear of childbirth before and after intervention, and an exploratory subsample completed a pain dot-probe task to examine pain-related attention processing.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group Mindfulness Intervention | Experimental | Behavioral: Group Mindfulness Intervention | Participants received an 8-week offline group mindfulness intervention in groups of 12 to 20. Sessions were conducted once weekly for 60 minutes by trained psychiatrists or psychological counseling professionals. |
| Group Discussion | Active comparator | Behavioral: Group Discussion | Participants attended an 8-week offline group discussion program in groups of 12 to 20, with one 60-minute session each week. |
| Health Education | Active comparator | Behavioral: Routine Health Education | Participants received routine outpatient health education once weekly for 8 weeks, with each session lasting approximately 15 to 20 minutes. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * Pregnant women at 20 to 30 gestational weeks. * No obvious pregnancy complications. * Able to complete questionnaires independently. * Willing to participate in the study and able to complete the 8-week intervention. * Provided written informed consent. Exclusion Criteria: * Self-harm behavior or suicidal tendency. * Current psychiatric medication use. * Severe mental disorder, such as schizophrenia, bipolar disorder, or organic mental disorder. * Severe somatic disease, such as abnormal liver or renal function, brain injury, heart disease, or epilepsy. * Pregnancy complications or expected inability to complete the intervention or follow-up.
| Facility | City | Country | Status |
|---|---|---|---|
| Shenzhen Kangning Hospital | Shenzhen, Guangdong | China |