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Mindfulness for Perinatal Distress

Group Mindfulness Intervention for Negative Emotions in Pregnant Women and Its Effect on Attentional Bias to Pain Cues

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07757243
Enrollment
356
Registered
2026-08-11
Start date
2021-09-21
Completion date
2022-10-01
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Anxiety

Keywords

Pregnancy, Mindfulness, Depressive Symptoms, Fear of Childbirth, Pain-Related Attention, Dot-Probe Task

Brief summary

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.

Interventions

BEHAVIORALGroup Mindfulness Intervention

The intervention consisted of eight weekly 60-minute offline group sessions. Each group included 12 to 20 participants. Sessions covered mindfulness theory, mindful breathing, body scan, mindful eating, sitting meditation, walking meditation, mindful stretching, and group reflection. The intervention was delivered by psychiatrists or psychological counseling professionals trained in mindfulness.

Participants attended eight weekly 60-minute offline group discussion sessions. Discussion topics included physical changes during pregnancy, emotional experiences, concerns about childbirth, and adaptation to daily life. The facilitator maintained group order and timing but did not provide structured psychological techniques or professional psychological guidance.

Participants received routine outpatient health education once weekly for 8 weeks. Each session lasted approximately 15 to 20 minutes and covered antenatal health care, precautions for prenatal visits, diet, and rest. No group psychological intervention was provided.

Sponsors

Shenzhen Kangning Hospital
Lead SponsorOTHER
Shenzhen Luohu District Maternal and Child Health Hospital
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in anxiety symptomsBaseline and immediately after the 8-week interventionSelf-Rating Anxiety Scale (SAS) Anxiety symptoms were assessed using the 20-item Zung Self-Rating Anxiety Scale (SAS). Each item is rated from 1 to 4. The raw total score ranges from 20 to 80 and is multiplied by 1.25 and rounded to obtain a standard score ranging from 25 to 100. The minimum possible standard score is 25 and the maximum is 100. Higher scores indicate more severe anxiety symptoms. A standard score of 50 or higher indicates the presence of anxiety symptoms. The standard score was used in the analysis.
Change in depressive symptomsBaseline and immediately after the 8-week interventionSelf-Rating Depression Scale (SDS) Depressive symptoms were assessed using the 20-item Zung Self-Rating Depression Scale (SDS). Each item is rated from 1 to 4. The raw total score ranges from 20 to 80 and is multiplied by 1.25 and rounded to obtain a standard score ranging from 25 to 100. The minimum possible standard score is 25 and the maximum is 100. Higher scores indicate more severe depressive symptoms. A standard score of 53 or higher indicates the presence of depressive symptoms. The standard score was used in the analysis.
Change in fear of childbirthBaseline and immediately after the 8-week interventionChildbirth Attitudes Questionnaire (CAQ) Fear of childbirth was assessed using the 16-item Childbirth Attitudes Questionnaire (CAQ). Each item is rated from 1 to 4, producing a total score ranging from 16 to 64. The minimum possible total score is 16 and the maximum is 64. Higher scores indicate greater fear of childbirth. Scores of 16-27 indicate no fear, 28-39 mild fear, 40-51 moderate fear, and 52-64 severe fear. A total score of 28 or higher indicates the presence of fear of childbirth. The total score was used in the analysis.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORJingchu Hu, Dr.

Shenzhen Kangning Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026