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

April 3, 2026 updated by: Amasya University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: ELİF KETEN EDİS, Assoc. Prof., PhD
  • Phone Number: 4802 +903582115005
  • Email: elifketen05@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 week
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.
4 week
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.
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amasya University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ELİF KETEN EDİS, Amasya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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