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临床试验/NCT07624253
NCT07624253尚未招募不适用

The Effect of Mindfulness-Based Psychoeducation Provided According to the Transtheoretical Model on Fear of Childbirth, Self-Perception, and Spiritual Well-Being in Pregnant Women With Fear of Childbirth

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

No additional masking is applied in this study.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Büşra Rümeysa Demirel

Research Assistant

Nigde Omer Halisdemir University

研究点 (1)

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