- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT05214846
Nulliparous Women and Education and Counseling
The Effect of Education and Counseling on Reducing Anxiety and Depression in Nullipar Pregnancy Women
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Pregnancy is a special process in a woman's life in which physiological, social and psychological changes occur. In this process, most women experience anxiety and depression, which are an important global health problem.The fear of uncertainty experienced by women who will become mothers for the first time may cause them to experience more anxiety/depression. The aim of this study was to investigate the effect of education and counseling on anxiety and depression of women.
This randomized controlled study was conducted at state hospital in northern Turkey , Obstetrics and Gynecology polyclinic between January 2022 and March 2022. Volunteer women undergoing polyclinic have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, Hospital Anxiety Depression Scale (HADS) was used for each patient. After obtaining written informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) were applied to both groups by face to face interview. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Atakum
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Samsun, Atakum, Турция, 55200
- Ondokuz Mayis University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- A healthy pregnant woman over 18 years of age,
- without a diagnosed psychiatric disease,
- without mental disability and communication problems,
- at 28 weeks of gestation,
- nulliparous,
- without fetal anomaly,
- without risky pregnancy
Exclusion Criteria:
- A healthy pregnant woman under 18 years of age,
- with a diagnosed psychiatric disease,
- with mental disability and communication problems,
- under 28 weeks of gestation,
- multiparous,
- with fetal anomaly,
- with risky pregnancy
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Education and Counseling
After obtaining written informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) was applied to both groups by face to face interview. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Women were counseled for 6 weeks. Anxiety-depression levels (post-test) were applied by phone call 6 weeks later.This education consisted of the definition and the purpose of pregnancy and pregnancy problems and nutrition during pregnancy, sexuality during pregnancy, number of fetal movements, preparation of the delivery bag, breast care, etc. |
After obtaining informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) was applied to both groups by face to face interview.
Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes.
In addition, the education and counseling given to the participants by the researcher.The experimental group was given a telephone number where they could receive consultancy services for 12 hours a day.
Pre-test was applied.
One day later, the pregnant woman was called and encouraged to call for all her questions, and she was informed that she would be returned when she called.
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|
Без вмешательства: control group
Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The control group was called by phone at the end of 6 weeks and told that they would be retested and 6 weeks later, they were called by phone and their anxiety and depression levels (posttest) were applied.
directed to continue
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Hospital Anxiety Depression Scale (HADS)
Временное ограничение: 30 minutes
|
The HADS contains 14 items and consists of two subscales: anxiety and depression.
Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression.
Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal' (Zigmont ve Snaith).
|
30 minutes
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Emine KOÇ, Asst.Prof, Ondokuz Mayıs University
- Учебный стул: Nazlı BALTACI, Asst.Prof, Ondokuz Mayıs University
Публикации и полезные ссылки
Общие публикации
- Ma X, Wang Y, Hu H, Tao XG, Zhang Y, Shi H. The impact of resilience on prenatal anxiety and depression among pregnant women in Shanghai. J Affect Disord. 2019 May 1;250:57-64. doi: 10.1016/j.jad.2019.02.058. Epub 2019 Feb 26.
- Gonzalez-Mesa E, Kabukcuoglu K, Korukcu O, Blasco M, Ibrahim N, Cazorla-Granados O, Kavas T. Correlates for state and trait anxiety in a multicultural sample of Turkish and Spanish women at first trimester of pregnancy. J Affect Disord. 2019 Apr 15;249:1-7. doi: 10.1016/j.jad.2019.01.036. Epub 2019 Jan 31.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
- 2020/737
Планирование данных отдельных участников (IPD)
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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. .