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NCT Number: NCT07510555

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

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Intervention group (Mindfulness-Based Stress Reduction Program)

Behavioral

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 mindfulness, mindfulness applications, the use of mindfulness in daily life, the mindfulness approach during pregnancy, stress management methods, and mindfulness, relaxation, and breathing exercises. The training sessions will be planned in a practice-based manner to encourage active participation. Mindfulness exercises will be practiced in the sessions, and participants will be given homework assignments to encourage the application of mindfulness skills to daily life. The trainings will be condu

Control Group

Behavioral

The control group will receive routine care. No interventions will be performed. Final tests will be administered 4 weeks after the preliminary tests.

Primary outcomes

Perinatal Anxiety Screening Scale

Time frame: 4 week

The Turkish validity and reliability study of the scale was conducted by Yazıcı et al. (2018). The scale consists of a total of 31 items and is a four-point Likert-type measurement tool. Items are scored with response options ranging from "never" to "always". Total scores above 16 indicate the presence of perinatal anxiety. As a result of the exploratory factor analysis, it was determined that the scale consists of four sub-dimensions. These sub-dimensions include: general anxiety and specific fears, perfectionism and control, social anxiety, general anxiety and adjustment difficulties, and acute anxiety, separation, and trauma. In the reliability analyses of the scale, Cronbach's alpha internal consistency coefficients were reported as 0.90, 0.89, 0.86, and 0.87 for the sub-dimensions, respectively.
Fetal Health Anxiety Scale

Time frame: 4 week

The validity and reliability study of the Turkish Fetal Health Anxiety Inventory was conducted by Gökbulut et al. (2024). This inventory aims to assess the anxiety levels experienced by pregnant women regarding the health of the fetus. The FSKE consists of 14 items in total, each containing four different statements to reflect the experiences of pregnant women. Scores obtained from the scale range from 0 to 42, with a higher total score indicating a higher level of fetal health anxiety. When the psychometric properties of the Turkish form of the scale were examined, it was observed that the internal consistency reliability was reported as Cronbach's alpha coefficient of 0.85.
Psychological Well-Being Scale

Time frame: 4 week

The Turkish adaptation of the scale was carried out by Telef (2013). The scale items have a seven-point Likert-type structure ranging from "strongly disagree" (1) to "strongly agree" (7). All statements in the scale are positively structured. The total scores that can be obtained from the scale range from 8 if all items are answered with "strongly disagree", and from 56 if all items are answered with "strongly agree". Higher scores indicate that the individual has higher levels of psychological resources and strengths. As a result of the reliability analyses of the scale, the Cronbach alpha internal consistency coefficient was determined as 0.80.

Study contacts

Contact information is provided by the study sponsor or research team.

ELİF KETEN EDİS, Assoc. Prof., PhD

CONTACT

[email protected]

+903582115005 ext. 4802

Mediha ÇAKMAK, BSc, RN

CONTACT

[email protected]

+903582115005

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 3, 2026
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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