Effect of the Mindfulness-Based Stress Reduction Program on Prenatal Attachment, Distress and Anx… (NCT06960109) | Clinical Trial Compass
CompletedNot Applicable
Effect of the Mindfulness-Based Stress Reduction Program on Prenatal Attachment, Distress and Anxiety Levels in Pregnant Women With Gestational Diabetes
Turkey (Türkiye)50 participantsStarted 2023-10-01
Plain-language summary
This randomized controlled study aims to evaluate the potential effects of a mindfulness-based stress reduction (MBSR) program on prenatal attachment, distress, and anxiety levels among pregnant women diagnosed with gestational diabetes mellitus (GDM). The study was conducted at Ankara Etlik City Hospital between October 2023 and 2024, and included 50 pregnant women with GDM, randomly assigned to an intervention group (n=25) or a control group (n=25). The MBSR program was implemented online for the intervention group, delivered in 8 sessions over 4 weeks.
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:
* Those diagnosed with Gestational Diabetes Mellitus,
* Those whose pregnancy is between 24-34 weeks,
* Those who can read and write in Turkish, and those who do not have hearing or speech problems,
* Pregnant women who volunteered to participate in the study.
Exclusion Criteria:
* Those who could not complete the Mindfulness-Based Stress Reduction Program,
* Pregnant women who gave birth while the study was ongoing.
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 Prenatal Attachment Inventory (PAI) scores
Timeframe: From pre-test (baseline) to 4 weeks post-intervention
2
Change in Prenatal Distress Questionnaire (NuPDQ) scores
Timeframe: From pre-test (baseline) to 4 weeks post-intervention
3
Change in State-Trait Anxiety Inventory (STAI-S-T) scores
Timeframe: From pre-test (baseline) to 4 weeks post-intervention