Labor Epidural Analgesia and Mother-Infant Bonding After Vaginal Delivery
Association Between Postpartum Recovery Quality Measured by ObsQoR-10 and Mother-Infant Bonding After Vaginal Delivery: The Role of Labor Epidural Analgesia
This prospective observational cohort study aims to evaluate the association between postpartum recovery quality and mother-infant bonding in women undergoing vaginal delivery. Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire, and mother-infant bonding will be evaluated using the Postpartum Bonding Questionnaire (PBQ).
Participants will be grouped according to routine clinical labor analgesia preference: women receiving labor epidural analgesia and women not receiving epidural analgesia. Additional assessments will include postpartum pain intensity, anxiety, depressive symptoms, and birth satisfaction.
Baseline psychological assessments will be performed before delivery. The primary postpartum evaluation will be conducted between 6 and 24 hours after delivery. Exploratory follow-up assessments will be performed by telephone during postpartum week 2.
The study aims to better understand the relationship between labor analgesia, postpartum recovery, and early mother-infant bonding outcomes after vaginal delivery.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This single-center prospective observational cohort study will be conducted at Atatürk University Research Hospital. The study will include term pregnant women planning vaginal delivery.
Participants will be classified into two cohorts according to routine clinical labor analgesia preference:
Women receiving labor epidural analgesia Women not receiving labor epidural analgesia No experimental intervention will be applied as part of the study protocol. Epidural analgesia, when used, will be administered according to routine clinical practice.
Primary Objective:
To evaluate the association between postpartum recovery quality measured using the ObsQoR-10 questionnaire and mother-infant bonding measured using the Postpartum Bonding Questionnaire (PBQ), and to investigate the role of labor epidural analgesia in this relationship.
Secondary Objectives:
To compare postpartum recovery quality between cohorts To compare mother-infant bonding outcomes between cohorts To evaluate postpartum pain, anxiety, depressive symptoms, and birth satisfaction To assess the association between obstetric variables and postpartum recovery outcomes
Assessments:
Prepartum:
STAIS-5 EPDS
Early postpartum period (6-24 hours):
ObsQoR-10 PBQ STAIS-5 EPDS Pain score (VAS/NRS) Birth satisfaction Likert scale
Postpartum week 2:
PBQ EPDS Participants will provide written informed consent before enrollment. All collected data will be anonymized and analyzed confidentially.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Ayşenur Dostbil, Associate Professor
- Номер телефона: +90 533 367 66 96
- Электронная почта: adostbil@hotmail.com
Учебное резервное копирование контактов
- Имя: Ayşe Ceren Hilal Güven, assistant doctor
- Номер телефона: +90 554 112 25 81
- Электронная почта: achg1995@gmail.com
Места учебы
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Erzurum, Турция (Туркие), 25000
- Ataturk University
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Контакт:
- Ayşe Ceren Hilal Güven, assistant doctor
- Номер телефона: 554-112-25-81
- Электронная почта: achg1995@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Female participants aged 18 to 40 years
- Term singleton pregnancy (≥37 weeks)
- Planned vaginal delivery
- ASA physical status II
- Ability to understand Turkish
- Written informed consent
Exclusion Criteria:
- Contraindications to epidural analgesia including coagulopathy, anticoagulant use, infection, or increased intracranial pressure
- Cesarean delivery
- High-risk pregnancy
- Neonatal intensive care unit requirement
- Major depressive disorder
- Anxiety disorder
- Current psychotropic medication use
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Labor Epidural Analgesia
Women undergoing vaginal delivery with labor epidural analgesia as part of routine clinical care.
Participants will undergo postpartum recovery, mother-infant bonding, anxiety, depression, pain, and birth satisfaction assessments during the postpartum period.
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Epidural analgesia administered during labor as part of routine clinical care for pain management during vaginal delivery.
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No Labor Epidural Analgesia
Women undergoing vaginal delivery without labor epidural analgesia as part of routine clinical care.
Participants will be evaluated for postpartum recovery quality, mother-infant bonding, anxiety, depressive symptoms, pain intensity, and birth satisfaction during the postpartum period.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mother-Infant Bonding Score
Временное ограничение: 6 to 24 hours after vaginal delivery
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Mother-infant bonding will be assessed using the Postpartum Bonding Questionnaire (PBQ), a 25-item scale with a total score ranging from 0 to 125.
Lower scores indicate better mother-infant bonding, while higher scores indicate poorer bonding.
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6 to 24 hours after vaginal delivery
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Postpartum Recovery Quality Score
Временное ограничение: 6 to 24 hours after vaginal delivery
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Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire.
Higher scores indicate better postpartum recovery quality.
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6 to 24 hours after vaginal delivery
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Postpartum Pain Intensity
Временное ограничение: 6 to 24 hours after vaginal delivery
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Postpartum pain intensity will be assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).
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6 to 24 hours after vaginal delivery
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Postpartum Anxiety Level
Временное ограничение: 6 to 24 hours after vaginal delivery
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Postpartum anxiety level will be assessed using the STAIS-5 questionnaire.
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6 to 24 hours after vaginal delivery
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Postpartum Depressive Symptoms
Временное ограничение: 6 to 24 hours after vaginal delivery
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Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS).
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6 to 24 hours after vaginal delivery
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Birth Satisfaction Score
Временное ограничение: 6 to 24 hours after vaginal delivery
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Birth satisfaction will be assessed using a 4-point Likert scale.
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6 to 24 hours after vaginal delivery
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Mother-Infant Bonding at Postpartum Week 2
Временное ограничение: 2 weeks after vaginal delivery
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Mother-infant bonding will be reassessed using the Postpartum Bonding Questionnaire (PBQ) during telephone follow-up at postpartum week 2.
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2 weeks after vaginal delivery
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Postpartum Depressive Symptoms at Week 2
Временное ограничение: 2 weeks after vaginal delivery
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Postpartum depressive symptoms will be reassessed using the Edinburgh Postnatal Depression Scale (EPDS) during telephone follow-up at postpartum week 2.
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2 weeks after vaginal delivery
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Ayşe Ceren Hilal Güven, assistant doctor, Ataturk University Department of Anesthesiology and Reanimation
Публикации и полезные ссылки
Общие публикации
- Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
- Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
- Feldman R. Mother-infant synchrony and the development of moral orientation in childhood and adolescence: direct and indirect mechanisms of developmental continuity. Am J Orthopsychiatry. 2007 Oct;77(4):582-97. doi: 10.1037/0002-9432.77.4.582.
- Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
- Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.
- Aydin N, Inandi T, Yigit A, Hodoglugil NN. Validation of the Turkish version of the Edinburgh Postnatal Depression Scale among women within their first postpartum year. Soc Psychiatry Psychiatr Epidemiol. 2004 Jun;39(6):483-6. doi: 10.1007/s00127-004-0770-4.
- Sultan P, Kamath N, Carvalho B, Bansal P, Elkhateb R, Dougan S, Whittington J, Guo N, El-Sayed Y, Mhyre J, Sharawi N. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100202. doi: 10.1016/j.ajogmf.2020.100202. Epub 2020 Aug 17.
- Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.
- Dissiz M, Bayri Bingol F, Demirgoz Bal M, Karacam Yilmaz ZD, Karakoc A, Bilgin Z. The Turkish version of the Postpartum Bonding Questionnaire (PBQ): Examination of the validity and reliability and scale structure. J Pediatr Nurs. 2024 Jul-Aug;77:131-139. doi: 10.1016/j.pedn.2024.03.012. Epub 2024 Mar 21.
- Bell AF, Andersson E. The birth experience and women's postnatal depression: A systematic review. Midwifery. 2016 Aug;39:112-23. doi: 10.1016/j.midw.2016.04.014. Epub 2016 May 7.
- Doner S, Efe YS, Elmali F. Turkish adaptation of the state-trait anxiety inventory short version (STAIS-5, STAIT-5). Int J Nurs Pract. 2024 Dec;30(6):e13304. doi: 10.1111/ijn.13304. Epub 2024 Sep 25.
- Brockington IF, Oates J, George S, et al. A screening questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health. 2001;3(4):133-140. doi:10.1007/s007370170010
- Waldenstrom U. Women's memory of childbirth at two months and one year after the birth. Birth. 2003 Dec;30(4):248-54. doi: 10.1046/j.1523-536x.2003.00254.x.
- Hodnett ED. Pain and women's satisfaction with the experience of childbirth: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S160-72. doi: 10.1067/mob.2002.121141.
- Simkin P. Just another day in a woman's life? Women's long-term perceptions of their first birth experience. Part I. Birth. 1991 Dec;18(4):203-10. doi: 10.1111/j.1523-536x.1991.tb00103.x.
- Bowyer A, Royse C. The importance of postoperative quality of recovery: influences, assessment, and clinical and prognostic implications. Can J Anaesth. 2016 Feb;63(2):176-83. doi: 10.1007/s12630-015-0508-7.
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
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Боль
- Неврологические проявления
- Психические расстройства
- Женские мочеполовые заболевания и осложнения беременности
- Осложнения беременности
- Расстройства настроения
- Послеродовые расстройства
- Депрессивное расстройство
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Родовая боль
- Депрессия, послеродовая
Другие идентификационные номера исследования
- B.30.2.ATA.0.01.00/234
- 2026/2 (Другой идентификатор: Atatürk University Clinical Research Ethics Committee)
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. .