Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth

NCT07624253 | Not Yet Recruiting DMC

• 2 other identifiers: Not assigned yet22504254-050.04
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Childbirth is a significant life event with important physical and psychological effects on pregnant women. Due to uncertainty during pregnancy, many women experience fear of childbirth. Fear of childbirth is a common condition that may negatively affect maternal well-being. Therefore, various psychosocial interventions have been developed to reduce this condition. Mindfulness-based approaches and psychoeducation programs are considered effective methods for reducing stress, anxiety, and fear by promoting non-judgmental awareness of the present moment. This study is designed as a randomized controlled experimental trial. The study population will consist of pregnant women attending the Obstetrics and Gynecology Outpatient Clinic of Niğde Ömer Halisdemir Training and Research Hospital who meet the inclusion criteria. The sample size was calculated using G\*Power 3.1.9.7 software. Based on an effect size of f = 0.38, 80% statistical power, and a 5% significance level, a minimum of 30 participants was required. Considering a 20% potential dropout rate, a total of 72 pregnant women (36 intervention and 36 control) will be included in the study. The inclusion criteria are being between 18 and 40 years of age, having a first pregnancy, being between 20 and 34 weeks of gestation, having a singleton and healthy pregnancy, being able to communicate in Turkish, and scoring 38 or higher on the Wijma Delivery Expectancy/Experience Questionnaire (Version A). Women with high-risk pregnancies, a history of psychiatric disorders, illiteracy, communication problems, or unwillingness to participate will be excluded. Withdrawal during the study, development of pregnancy complications, or inability to continue the intervention will be considered exclusion criteria. Data will be collected using a Sociodemographic Information Form, the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A), the Self-Perception Scale for Pregnant Women, and the Spiritual Well-Being Scale. The W-DEQ A measures fear of childbirth, the Self-Perception Scale assesses maternal and body perception during pregnancy, and the Spiritual Well-Being Scale evaluates the level of spiritual well-being. At the beginning of the study, eligible participants will be informed about the research and written informed consent will be obtained. Data collection forms will first be administered face-to-face. Pregnant women scoring 38 or above on the W-DEQ A will then be randomly assigned to intervention and control groups using a computer-based randomization method (randomizer.org). The intervention group will receive a mindfulness-based psychoeducation program adapted according to the Transtheoretical Model. The intervention will be delivered in group sessions of 6-10 participants, twice a week for 4 weeks, with each session lasting approximately 45-60 minutes. The program includes psychoeducation about pregnancy and childbirth, mindfulness exercises, emotional awareness activities, and coping strategies for fear of childbirth. The control group will receive routine obstetric care only. Post-intervention assessments will be conducted in both groups using the same measurement tools. Data analysis will be performed using SPSS version 25.0. Descriptive statistics will be calculated, and depending on data distribution, independent samples t-test, paired samples t-test, ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and chi-square test will be used. The level of statistical significance will be set at p \< 0.05. The aim of this study is to evaluate the effect of a mindfulness-based psychoeducation intervention based on the Transtheoretical Model on fear of childbirth, self-perception, and spiritual well-being in pregnant women experiencing fear of childbirth.

Conditions

Fear of Childbirth; Pregnancy

Keywords

fear of childbirth; pregnancy; mindfulness; psychoeducation; self-perception; spiritual well-being

Outcome Measures

Primary Outcomes (1)

• Fear of childbirth (W-DEQ A score)

  Developed by Wijma et al. in 1988 (Wijma et al., 1998), the scale was adapted into Turkish by Körükçü et al. in 2012. Fear of childbirth will be measured using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A). The scale assesses the fear of childbirth, with higher scores indicating higher levels of fear. The scale consists of 33 items and 6 subscales, utilizing a 6-point Likert-type format (0 = completely, 5 = not at all). The total score obtainable from the scale ranges from a minimum of 0 to a maximum of 165. Scores between 0-37 indicate mild fear, 38-65 indicate moderate fear, 66-84 indicate severe fear, and scores of 85 and above indicate clinical-level fear. In this study, participants scoring 38 or above (corresponding to moderate and severe fear levels) will be included. Measurements will be conducted at baseline (pre-intervention) and immediately after the completion of the intervention.

  Baseline and immediately post-intervention

Secondary Outcomes (2)

• Self-Perception of Pregnant Women

  Baseline and immediately post-intervention

• Spiritual Well-Being

  Baseline and immediately post-intervention

Study Arms (2)

Mindfulness-Based Psychoeducation Group

EXPERIMENTAL

Participants will receive a mindfulness-based psychoeducation program adapted according to the Transtheoretical Model. The intervention will be delivered in groups of 6-10 pregnant women twice a week for 4 weeks in an online format. Each session will last approximately 45-60 minutes. The program includes psychoeducation about pregnancy and childbirth, mindfulness exercises, emotional awareness activities, and coping strategies for fear of childbirth. The aim of the intervention is to reduce fear of childbirth and improve self-perception and spiritual well-being. The intervention will be conducted online to increase participant comfort and accessibility.

Behavioral: Mindfulness-Based Psychoeducation

Control Group

NO INTERVENTION

Participants in this arm will receive routine obstetric care provided by the hospital during pregnancy. No additional psychological, educational, or mindfulness-based intervention will be applied throughout the study period.

Interventions

Mindfulness-Based Psychoeducation BEHAVIORAL

Participants in this arm will receive a mindfulness-based psychoeducation program adapted according to the Transtheoretical Model. The intervention will be delivered in groups of 6-10 pregnant women twice a week for 4 weeks in an online format. Each session will last approximately 45-60 minutes. The program includes psychoeducation about pregnancy and childbirth, mindfulness exercises, emotional awareness activities, and coping strategies for fear of childbirth. The aim is to reduce fear of childbirth and improve self-perception and spiritual well-being.

Mindfulness-Based Psychoeducation Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: All genders are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in the study,
• Aged between 18-40 years,
• Primigravida (first pregnancy),
• Not having received any childbirth preparation class,
• Scoring 38 or above on the Wijma Delivery Expectancy/Experience Questionnaire,
• Between 20 and 34 weeks of gestation,
• Having a healthy pregnancy,
• Having a singleton pregnancy,
• Carrying a live fetus,
• Not in active labor,
• Able to speak Turkish and without any language, comprehension, or communication problems to understand and answer the questions.

You may not qualify if:

• Those who do not agree to participate in the study,
• Pregnant women under 18 years of age and over 41 years of age,
• Diagnosed with high-risk pregnancy,
• Illiterate,
• Having a contagious disease,
• Having a current or past psychiatric disorder requiring treatment,
• Having mobility, hearing, or psychological disabilities,
• With a gestational age below 20 weeks or above 32 weeks,
• Those who have entered active labor.
• Participants who withdraw consent and wish to leave the study during the study period,
• Participants who are unable to adapt to the intervention process,
• Participants experiencing communication or internet connectivity problems,
• Participants who develop complications during the intervention (e.g., onset of labor, decreased fetal movements, etc.) requiring hospitalization will be excluded from the study.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: collaborator
• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir Eğitim ve Araştırma Hastanesi

Niğde, Turkey (Türkiye)

Location

Study Officials

• Gamze Sarıkoç, Associate Professor

  Saglik Bilimleri University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Büşra Rümeysa Demirel, PhD Student

CONTACT

+90 5551964396; bdemirel@ohu.edu.tr

Gamze Sarıkoç, Associate Professor

CONTACT

+90 530 642 23 13; gamze.sarikoc@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional masking is applied in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The study is a randomized controlled trial with two parallel groups (intervention and control), in which the effect of the intervention will be evaluated comparatively using pre-test and post-test measurements.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 15, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)