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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Intervention group (Mindfulness-Based Stress Reduction Program); Behavioral: Control group

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ELİF KETEN EDİS, Assoc. Prof., PhD; Phone Number: 4802 +903582115005; Email: elifketen05@gmail.com
• Study Contact Backup: Name: Mediha ÇAKMAK, BSc, RN; Phone Number: +903582115005; Email: cakmakmediha8@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Pregnant women will be informed about the study and, after obtaining their written consent, pre-tests will be administered (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-Being Scale). Then, women in the intervention group will receive a Mindfulness-based stress reduction program for 4 weeks, with two sessions per week. Four weeks after the pre-tests, post-tests (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-being Scale) will be administered to women in both the intervention and control groups.	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 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
Experimental: Control group; Pregnant women will be informed about the study and, after obtaining their written consent, pre-tests will be administered (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-Being Scale). The control group will receive no intervention. Four weeks after the pre-tests, post-tests (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-being Scale) will be administered to women in both the intervention and control groups.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perinatal Anxiety Screening Scale	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.	4 week
Fetal Health Anxiety Scale	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.	4 week
Psychological Well-Being Scale	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.	4 week

Collaborators and Investigators

• Sponsor: Amasya University
• Investigators: Study Director: ELİF KETEN EDİS, Amasya University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Mindfulness; Well-being; Concerns
• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: M-tez

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No