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CompletedNCT07757243Updated Sep 11, 2026

Mindfulness for Perinatal Distress

An interventional study of Group Mindfulness Intervention and Group Discussion in Perinatal Anxiety, sponsored by Shenzhen Kangning Hospital. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Shenzhen Kangning Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Perinatal Anxiety

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Keywords

  • Pregnancy
  • Mindfulness
  • Depressive Symptoms
  • Fear of Childbirth
  • Pain-Related Attention
  • Dot-Probe Task
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
356 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Group Mindfulness Intervention

  • Active comparator
    Group Discussion

    Participants attended an 8-week offline group discussion program in groups of 12 to 20, with one 60-minute session each week.

    Behavioral: Group Discussion

  • Active comparator
    Health Education

    Participants received routine outpatient health education once weekly for 8 weeks, with each session lasting approximately 15 to 20 minutes.

    Behavioral: Routine Health Education

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.

  • BehavioralGroup Discussion

    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.

  • BehavioralRoutine Health Education

    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.

05

What researchers measure

Primary outcomes

  1. Change in anxiety symptoms

    Self-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.

    Time frame: Baseline and immediately after the 8-week intervention

  2. Change in depressive symptoms

    Self-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.

    Time frame: Baseline and immediately after the 8-week intervention

  3. Change in fear of childbirth

    Childbirth 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.

    Time frame: Baseline and immediately after the 8-week intervention

06

Study locations

1 site
  • Shenzhen Kangning Hospital
    Shenzhen, Guangdong 518020, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07757243
Lead sponsor
Shenzhen Kangning Hospital
Collaborators
Shenzhen Luohu District Maternal and Child Health Hospital
Responsible party
Jingchu Hu (Principal Investigator, Shenzhen Kangning Hospital) — Principal investigator
First posted
Aug 11, 2026
Start date
Sep 21, 2021
Primary completion
Oct 1, 2022
Completion
Oct 1, 2022
Last update
Sep 11, 2026

Study contacts

Jingchu Hu, Dr.
principal investigator · Shenzhen Kangning Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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