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The Effect of a Mindfulness-Based Stress Reduction Program Applied to Nulliparous Pregnant Women

No phase Interventional Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention group (Mindfulness-Based Stress Reduction Program), Control group.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of a Mindfulness-Based Stress Reduction Program Applied to Nulliparous Pregnant Women on Prenatal Anxiety, Fetal Health Concern, and Psychological Well-Being

Overview

Mindfulness-based stress reduction programs are among the effective methods that can contribute to managing anxiety during pregnancy, strengthening mother-fetus interaction, and supporting psychological well-being. In this context, this study will examine the effect of a mindfulness-based stress reduction program on prenatal anxiety, fetal health concerns, and psychological well-being. The aim of this study is to determine the effect of a mindfulness-based stress reduction program applied to pregnant women who have not previously given birth on prenatal anxiety, fetal health concerns, and psychological well-being.

Detailed description

Pregnancy is a multifaceted period in a woman's life requiring physical and mental adjustment. During this process, women, especially those experiencing their first pregnancy, may experience prenatal anxiety and fetal health concerns due to uncertainties surrounding the birthing process and fetal health. Inadequate management of this anxiety and stress can negatively impact psychological well-being. Increased anxiety levels can also affect a mother's perception of the pregnancy and her expectations regarding childbirth. This situation can pose risks to both maternal health and fetal development. Therefore, the importance of psychologically supportive and structured interventions during pregnancy is increasing. Mindfulness-based approaches help individuals recognize their emotions and thoughts without judgment and cope with stress more effectively. Accordingly, this study aims to examine the effects of a mindfulness-based stress reduction program applied to nulliparous pregnant women on prenatal anxiety, fetal health concerns, and psychological well-being.

Interventions

  • Behavioral Intervention group (Mindfulness-Based Stress Reduction Program)
    Pregnant women will be informed about the study and, after obtaining their written consent, pre-tests will be administered. Then, women in the intervention group will receive a Mindfulness-based stress reduction program for 4 weeks, with two sessions per week. The program will cover topics such as the physiology of pregnancy and the fetus, physiological and psychological changes in the mother during pregnancy, fetal development, adaptation to the maternal role, the concept and foundations of min
  • Behavioral Control group
    The control group will receive routine care. No interventions will be performed. Final tests will be administered 4 weeks after the preliminary tests.

Primary outcome measures

  • Perinatal Anxiety Screening Scale [Time frame: 4 week]
  • Fetal Health Anxiety Scale [Time frame: 4 week]
  • Psychological Well-Being Scale [Time frame: 4 week]

Eligibility criteria

Inclusion criteria

  • Be 18 years of age and older,
  • Have at least a primary school graduate
  • Not having given birth before
  • Be between the 12th and 28th weeks of pregnancy,
  • Have internet access

Exclusion criteria

  • Having any communication problems (language, hearing, vision, speech, etc.),
  • Having a diagnosis of high-risk pregnancy, or having a diagnosis of a psychiatric illness (depression, psychosis, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07510555 · M-tez

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗