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Идёт набор NCT07369726

Effects of Mobilization and Caffeine After Cesarean

Без фазы С лечением Gastrointestinal Motility Postoperative Pain Psychological Well-Being

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: caffeine consumption, Decaffeinated coffee.
Кому может быть актуально
Состояния в реестре: Gastrointestinal Motility, Postoperative Pain, Psychological Well-Being. Базовые параметры: 18 лет — 35 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
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Официальное название

The Effect of Early Post-Cesarean Mobilization and Caffeine Consumption on Bowel Motility, Pain, and Psychological Well-being: A Randomized Controlled Trial

Обзор

This study Maims to assess bowel motility, pain and psychological well-being in women in the post-cesarean period by mobilizing them early and encouraging them to consume coffee.

Подробное описание

In the intervention group, the goal is to initiate bowel motility by mobilizing women early in the post-cesarean period. This increased bowel motility will facilitate gas expulsion, thus minimizing pain levels. Caffeine consumption will help keep pain levels at a minimum. By minimizing pain, women will experience positive psychological well-being.

Вмешательства

  • Пищевая добавка caffeine consumption
    The women in the intervention group will be mobilised at the 4-hour mark. The intervention group will be given caffeinated Turkish coffee at 6-hour intervals.
  • Пищевая добавка Decaffeinated coffee
    The women in the control group will be mobilised at the 6-hour mark. The control group will be given decaffeinated Turkish coffee at 6-hour intervals.

Первичные конечные точки

  • Change in postoperative pain after caesarean section within 24 hours from baseline [Срок оценки: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours]
  • Change in postoperative Bowel Motility after caesarean section within 24 hours from baseline [Срок оценки: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours]
  • Change in postoperative Psychological Well-being after caesarean section within 24 hours from baseline [Срок оценки: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours]

Критерии участия

Критерии включения

  • Being between 18 and 35 years of age,
  • Women who underwent cesarean delivery under spinal anesthesia,
  • Having a post-cesarean pain level of 4 or higher,
  • Being able to understand and write Turkish and communicate effectively with researchers.

Критерии исключения

  • Women who underwent emergency cesarean delivery,
  • Those with pregnancy complications (preeclampsia, placenta previa, etc.),
  • Those with a history of chronic gastrointestinal disease (e.g., irritable bowel syndrome, Crohn's disease, ulcerative colitis),
  • Those with sensitivity or allergy to caffeine,
  • Those with a history of chronic pain syndrome or dependence on analgesics,
  • Regular coffee drinkers (≥2 cups per day),
  • Intraoperative complications such as bowel or bladder injury,

i) Those who cannot comply with the study protocol or complete the follow-up process.

Removal Criteria:

  • Participants are excluded from the study under the following conditions:
  • During surgery If complications occur (e.g., bladder or bowel injury, excessive bleeding),
  • Postoperative complications requiring admission to the intensive care unit (ICU) for the mother or newborn,
  • Development of severe postoperative nausea, vomiting, or intolerance to oral intake,
  • Inability to consume or refusal to consume coffee according to the study protocol,
  • Withdrawal of consent by the participant at any point during the study,
  • Failure to comply with surgical procedures or loss of follow-up,
  • Development of medical conditions during follow-up that may affect study results (e.g., acute infections, neurological disorders).

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
  • KTO Karatay University — Konya

Идентификаторы

NCT: NCT07369726 · AIBU-EBE-EK-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗