NCT07307196

The Effect of a Mindfulness-Based Stress Reduction Program on Pregnancy Adaptation, Stress, and Fetal Anxiety Levels in Women Who Conceived After Infertility Treatment

THE EFFECT OF A MİNDFULNESS-BASED STRESS REDUCTİON PROGRAM ON PREGNANCY ADAPTATİON, STRESS, AND FETAL ANXİETY LEVELS İN WOMEN WHO CONCEİVED AFTER INFERTİLİTY TREATMENT: A RANDOMİZED CONTROLLED TRİAL

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Kahramanmaras Sutcu Imam University · Academic / Other
• Sex: Female
• Age: 18 Months
• Healthy volunteers: Accepted

Summary

Infertility treatment is a long and challenging process. Women who become pregnant after this process may experience stress, anxiety and intense concerns about the baby's health alongside their happiness. These feelings can negatively affect the mother's adjustment to pregnancy and her psychological well-being. This study was designed to examine the effects of the Mindfulness-Based Stress Reduction (MBSR) programme, administered to women who became pregnant after infertility treatment, on: stress levels during pregnancy, adaptation to pregnancy, and foetal (baby's health-related) anxiety. Pregnant women participating in the study will be divided into two groups: an experimental group and a control group. Women in the experimental group will receive mindfulness-based stress reduction training lasting approximately 4 weeks. This programme includes breathing exercises, meditation, body awareness, self-compassion exercises, and practices aimed at strengthening the mother-baby bond. The control group will not receive any training during this period. Translated with DeepL.com (free version)

Detailed description

Infertility treatment is a physically and emotionally demanding process. Although achieving pregnancy after infertility treatment is often perceived as a positive outcome, many women continue to experience significant psychological challenges during pregnancy, including heightened stress, difficulty adapting to pregnancy, and persistent anxiety regarding fetal health. These emotional responses may negatively affect maternal well-being, pregnancy adaptation, and pregnancy outcomes. Despite the growing body of evidence supporting mindfulness-based interventions during pregnancy, there is limited research focusing specifically on women who conceive following infertility treatment. Mindfulness-Based Stress Reduction (MBSR) is a structured, evidence-based program that aims to enhance awareness of present-moment experiences through mindfulness practices such as meditation, breathing exercises, body awareness, gentle yoga, and self-compassion practices. Previous studies have demonstrated that MBSR can effectively reduce stress and anxiety and improve psychological well-being in various populations, including pregnant women and women undergoing infertility treatment. However, the effects of MBSR on pregnancy adaptation and fetal health anxiety among women who become pregnant after infertility treatment have not been adequately investigated. This randomized controlled study is designed to evaluate the effectiveness of an MBSR program on pregnancy adaptation, perceived stress, and fetal health anxiety in women who conceived following infertility treatment. Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive an MBSR program delivered over four weeks, consisting of structured sessions that include mindfulness meditation, breathing-focused practices, body scan exercises, gentle yoga, emotional awareness, self-compassion training, and practices aimed at strengthening maternal-fetal bonding. Participants will also be encouraged to engage in daily mindfulness practices at home. The control group will receive routine prenatal care and will not participate in any structured psychological or mindfulness-based intervention during the study period. After completion of post-intervention assessments, participants in the control group who wish to receive the MBSR training will be offered the program. Data will be collected at baseline (pre-test) and after completion of the intervention (post-test) using validated instruments to assess pregnancy-related distress, pregnancy adaptation, and fetal health anxiety. The primary outcomes of the study are changes in perceived stress levels, pregnancy adaptation, and fetal health anxiety scores between the intervention and control groups. The findings of this study are expected to provide evidence on the potential benefits of MBSR as a supportive, non-pharmacological intervention for improving psychological well-being and pregnancy adaptation in women who conceive following infertility treatment. The results may contribute to the development of holistic, evidence-based prenatal care approaches and inform healthcare professionals about effective strategies to support this vulnerable population.

Conditions

• Infertile Females or Females With Ovarian Insufficiency
• Pre - Delivery Pregnant Women

Interventions

Type	Name	Description
BEHAVIORAL	MBSR	Participants allocated to the experimental arm will receive a structured Mindfulness-Based Stress Reduction (MBSR) program in addition to routine prenatal care. The MBSR intervention is delivered in a group format by a trained researcher and is adapted for pregnant women who conceived following infertility treatment. The program is conducted over 4 weeks, with two sessions per week. Each session includes guided mindfulness practices such as breathing-focused meditation, body scan exercises, gentle pregnancy-safe yoga movements, emotional awareness practices, and self-compassion exercises. The intervention also includes mindfulness practices aimed at strengthening maternal-fetal bonding, such as loving-kindness meditation directed toward the fetus and mindful awareness of bodily sensations related to pregnancy. Participants are encouraged to engage in daily home practice using provided audio-guided materials. The primary purpose of this arm is to reduce pregnancy-related stress and fe

Timeline

• Start date: 2026-01-10
• Primary completion: 2026-02-28
• Completion: 2026-06-30
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Turkey (Türkiye)