Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth

NCT07624253 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-06-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

Mindfulness-Based Psychoeducation

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.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    collaborator OTHER
  • Nigde Omer Halisdemir University

    lead OTHER

Principal Investigators

  • Gamze Sarıkoç, Associate Professor · Saglik Bilimleri University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-01-15
Completion
2028-07-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624253 on ClinicalTrials.gov