Mindfulness Psychoeducation Based on Transtheoretical Model... | Clinical Trial | StuddyBuddy@endsection Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
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Not Yet Recruiting NCT07624253

Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth

Conditions: Fear of Childbirth, Pregnancy

Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Nigde Omer Halisdemir University

Location: Niğde Ömer Halisdemir Eğitim ve Araştırma Hastanesi Niğde

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. Withdrawal / Exclusion Criteria * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07624253). StuddyBuddy aggregates publicly available trial information.