- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07624253
Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
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
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Büşra Rümeysa Demirel, PhD Student
- Номер телефона: +90 5551964396
- Электронная почта: bdemirel@ohu.edu.tr
Учебное резервное копирование контактов
- Имя: Gamze Sarıkoç, Associate Professor
- Номер телефона: +90 530 642 23 13
- Электронная почта: gamze.sarikoc@sbu.edu.tr
Места учебы
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Niğde, Турция (Туркие)
- Niğde Ömer Halisdemir Eğitim ve Araştırma Hastanesi
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Контакт:
- Büşra Rümeysa Demirel, PhD Student
- Номер телефона: +90 5551964396
- Электронная почта: bdemirel@ohu.edu.tr
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Контакт:
- Gamze Sarıkoç, Associate Professor
- Номер телефона: +90 530 642 23 13
- Электронная почта: gamze.sarikoc@sbu.edu.tr
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Главный следователь:
- Büşra Rümeysa Demirel, PhD Student
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Младший исследователь:
- Gamze Sarıkoç, Associate Professor
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Mindfulness-Based Psychoeducation Group
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.
|
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.
|
|
Без вмешательства: Control Group
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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Fear of childbirth (W-DEQ A score)
Временное ограничение: Baseline and immediately post-intervention
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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.
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Baseline and immediately post-intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Self-Perception of Pregnant Women
Временное ограничение: Baseline and immediately post-intervention
|
The Self-Perception of Pregnant Women Scale was developed by Kumcağız et al. in 2017.The scale evaluates maternal perception related to pregnancy, including maternal identity and body image.
It consists of 12 items and utilizes a 4-point Likert-type format (4: always, 3: mostly, 2: sometimes, 1: never).
The scale comprises two subdimensions: In the "Maternal Perception of Pregnancy" subscale, the maximum obtainable score is 28, and the minimum is 7. Higher scores in this subscale indicate a higher level of positive maternal perception, whereas lower scores indicate a lower level of maternal perception.
In the "Body Image of Pregnancy" subscale, the maximum obtainable score is 20, and the minimum is 5. Higher scores in this subscale indicate a more negative body image, whereas lower scores indicate a more positive body image (Kumcağız et al., 2017).
Measurements will be conducted at baseline (pre-intervention) and immediately after the completion of the intervention.
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Baseline and immediately post-intervention
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Spiritual Well-Being
Временное ограничение: Baseline and immediately post-intervention
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It is a scale developed by Ekşi and Kardaş in 2017.
The scale consists of 29 items across 3 subdimensions: "transcendence", "harmony with nature", and "anomie", and utilizes a 5-point Likert-type format (1 = Not at all suitable for me, 2 = Not suitable for me, 3 = Somewhat suitable for me, 4 = Quite suitable for me, 5 = Completely suitable for me).
The total score obtainable from the scale ranges from a minimum of 29 to a maximum of 145.
Items in the anomie subdimension are reverse scored.
As the total scores increase, spiritual well-being increases.
While higher scores in the "transcendence" and "harmony with nature" subscales represent positive spiritual well-being, higher scores in the "anomie" subdimension indicate lower spiritual well-being (Ekşi and Kardaş, 2017).
Measurements will be conducted at baseline (pre-intervention) and immediately after the completion of the intervention.
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Baseline and immediately post-intervention
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Gamze Sarıkoç, Associate Professor, Saglik Bilimleri University
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- Not assigned yet
- 22504254-050.04 (Другой идентификатор: Nigde Omer Halisdemir University Ethics Committee)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .