Mindfulness for Perinatal Distress (NCT07757243) | Clinical Trial Compass
CompletedNot Applicable
Mindfulness for Perinatal Distress
China356 participantsStarted 2021-09-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in anxiety symptoms
Timeframe: Baseline and immediately after the 8-week intervention
2
Change in depressive symptoms
Timeframe: Baseline and immediately after the 8-week intervention
3
Change in fear of childbirth
Timeframe: Baseline and immediately after the 8-week intervention