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

NCT07510555 | Not Yet Recruiting

• 1 other identifier: M-tez
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy

Keywords

Pregnancy; Mindfulness; Well-being; Concerns

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

EXPERIMENTAL

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

Interventions

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.

Control group

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Amasya University: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• ELİF KETEN EDİS

  Amasya University

  STUDY DIRECTOR

Central Study Contacts

ELİF KETEN EDİS, Assoc. Prof., PhD

CONTACT

+903582115005; elifketen05@gmail.com

Mediha ÇAKMAK, BSc, RN

CONTACT

+903582115005; cakmakmediha8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study has a randomized controlled experimental design

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share