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Набор по приглашению NCT07304037

The Effect of Skin-to-Skin Contact Applied in the Early Postpartum Period on Maternal Pain, Birth Satisfaction, and Maternal Vital Signs Dynamics

Без фазы С лечением Maternal Vital Signs Skin-to-skin Contact Birth Satisfaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: A solid hour of skin-to-skin contact.
Кому может быть актуально
Состояния в реестре: Maternal Vital Signs, Skin-to-skin Contact, Birth Satisfaction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Skin-to-skin contact (STSC) initiated within the first hour after birth is a fundamental practice that supports both the mother's and the newborn's physiological and psychological adaptation (Çelik \& Kök, 2022). The World Health Organization recommends at least 90 minutes of uninterrupted SKC immediately after birth and defines this practice as a mandatory component of care under the Baby-Friendly Hospital Initiative (World Health Organization, 2024; Abdulghani et al., 2018; Sharma, 2016). The positive effects of TTT on maintaining the newborn's temperature, glucose regulation, physiological stability, and mother-infant bonding have been proven (Sezici \& Yiğit, 2020; Safar et al., 2018). In addition, it has been reported that it can shorten the third stage of labor by increasing maternal oxytocin release and reduce maternal stress and anxiety (Püsküllüoğlu et al., 2022; Harati Kabir et al., 2024). In the study, mothers in the intervention group will receive one hour of uninterrupted TTT immediately after delivery; routine midwifery care will continue in the control group. In both groups, maternal pain levels, birth satisfaction, and vital signs (body temperature, oxygen saturation, heart rate, and blood pressure) will be assessed immediately after delivery, and at 30, 60, and 90 minutes. The sample size was calculated using GPower, and a total of 68 participants (34 in each group) will be included in the study. Inclusion criteria include women aged 18 years or older who have had a full-term vaginal delivery and have a single, uncomplicated pregnancy. The data collection tools used will be the Demographic Information Form and the Visual Analog Scale (VAS). The findings of the study are expected to enhance the quality of midwifery care by supporting the integration of TTT into clinical practice in early postpartum care.

Подробное описание

H1: There is a difference in pain scores measured using the Visual Analog Scale (VAS) between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group immediately after birth, at 30, 60, and 90 minutes.

H1: There is a difference in birth satisfaction scores measured using the Visual Analog Scale (VAS) between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group immediately after birth, at 30, 60, and 90 minutes.

H1: There is a difference between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group in terms of maternal body temperature, oxygen saturation, heart rate, and blood pressure measurements taken immediately after birth and at 30, 60, and 90 minutes.

Вмешательства

  • Процедура A solid hour of skin-to-skin contact
    Immediately after birth, skin-to-skin contact is maintained for one hour without interruption. Pain levels, birth satisfaction levels, and maternal vital signs (body temperature, oxygen saturation, heart rate, and blood pressure) are assessed at 30, 60, and 90 minutes postpartum.

Первичные конечные точки

  • Visuel Analog Scale -Pain [Срок оценки: At 30, 60, and 90 minutes after birth]
  • Visuel Analog Scale- Birth satisfaction [Срок оценки: At 30, 60, and 90 minutes after birth]

Критерии участия

Критерии включения

  • Voluntarily agree to participate in the study
  • Be able to read, understand, and write in Turkish
  • Be 18 years of age or older
  • Have given birth vaginally
  • Have given birth to a single baby
  • Be at term (between 38-42 weeks of gestation)
  • Have given birth vaginally in vertex presentation
  • Estimated fetal weight between 2500-4000 grams
  • Not having received any analgesia or anesthesia to relieve pain and fatigue during labor
  • Having a pregnancy without maternal or fetal complications

Критерии исключения

  • Multiple pregnancies
  • High-risk pregnancies with complications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul University Cerrahpaşa — Istanbul

Публикации

  • Abdulghani N, Edvardsson K, Amir LH. Worldwide prevalence of mother-infant skin-to-skin contact after vaginal birth: A systematic review. PLoS One. 2018 Oct 31;13(10):e0205696. doi: 10.1371/journal.pone.0205696. eCollection 2018. PMID 30379859
  • Sharma A. Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial. Afr Health Sci. 2016 Sep;16(3):790-797. doi: 10.4314/ahs.v16i3.20. PMID 27917213
  • Safari K, Saeed AA, Hasan SS, Moghaddam-Banaem L. The effect of mother and newborn early skin-to-skin contact on initiation of breastfeeding, newborn temperature and duration of third stage of labor. Int Breastfeed J. 2018 Jul 16;13:32. doi: 10.1186/s13006-018-0174-9. eCollection 2018. PMID 30026787
  • Kabir FH, Razavinia F, Keshavarz M, Mousavi SS, Haghani H. Effect of Companion Presence during Skin-to-Skin Contact on Maternal Anxiety: A Randomized Clinical Trial. Indian Pediatr. 2024 Mar 15;61(3):230-236. PMID 38469838
  • Püsküllüoğlu, B., Göker, A. & Kosova, F. The effect of skin-to-skin contact on the expulsion time of the placenta and delivery hormones. DEU Tıp Dergisi, 2022, 36(3), 237-242. https://doi.org/10.18614/deutip1230581
  • Sezici E, Yigit D. The Effect of Skin-to-Skin Contact on Maternal Anxiety, Heart Rate, and Oxygen Saturation during the Vaccination of One-Month-Old Infants. Compr Child Adolesc Nurs. 2020 Dec;43(4):410-420. doi: 10.1080/24694193.2020.1721614. Epub 2020 Feb 19. PMID 32073934
  • Çelik, İ. & Kök, G. Examination of nurses' and midwives' knowledge and attitudes regarding early skin-to-skin contact between mother and newborn. Istanbul Development University Journal of Health Sciences, 2022, 17, 558-574.

Идентификаторы

NCT: NCT07304037 · 2025/332

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗