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临床试验/NCT06359223
NCT06359223已完成不适用

Effect of Coffee Consumption on Postoperative Pain and Intestinal Motility After Caesarean Section: Randomized Controlled Study

TC Erciyes University2 个研究点 分布在 2 个国家目标入组 57 人开始时间: 2024年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Postoperative Pain

研究概览

简要总结

Objective The aim of this study was to investigate whether postoperative coffee intake affects pain levels and bowel motility in women undergoing cesarean delivery.

Design: It will be conducted as a randomized controlled experimental study. Method: It is a randomized controlled experimental study: This randomized controlled clinical trial will be conducted between May and December 2024 in accordance with the Consolidated Standards of Reporting Trials. A total of 60 women will be randomly assigned to the intervention group (n=30) or the control group (n=30). Participants in the intervention group will receive 100 mg caffeine in coffee at 6 and 12 hours after surgery in addition to routine postoperative care. The control group will receive only routine postoperative care. Pain will be assessed using Visual Analog Scale (VAS) and bowel activity will be monitored by time to first defecation, gas passage and bowel sounds.

Keywords: Caesarean section, Coffee, Pain, Motility

详细描述

Cesarean section is one of the most common surgical operations in obstetrics and gynecology. While the caesarean section rate is 25-40% in developed countries such as the United States, Ireland, England and China, this rate is 48% in Turkey. For this reason, post-cesarean pain and delayed bowel motility are among the common problems due to the surgical intervention. Post-cesarean pain can delay return to normal daily activities and negatively affect the mother's psychological health, breastfeeding, and mother-infant bonding. In addition to pain, delayed bowel motility due to changes in the autonomic nervous system is among the most common problems experienced after cesarean section. Appropriate health care provided by medical personnel during the postpartum period can enable the woman to be discharged early. Therefore, non-invasive, low-cost and uncomplicated methods should be preferred to reduce pain in the postoperative period and ensure the first spontaneous passing of gas and early defecation. In the literature review, although there is no study determining the effect of drinking coffee on pain in the postoperative period, there are studies stating that coffee can contribute to early GI motility in the postoperative period after abdominal surgery and shorten the time for passing gas, defecation and discharge. Therefore, this research will be conducted as a randomized controlled experimental study with the aim of minimizing the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • had a cesarean delivery with spinal anesthesia,
  • had a postoperative pain level of 4 or higher,
  • could read and write Turkish,
  • could communicate effectively with the researchers.

排除标准

  • Those who underwent emergency cesarean section,
  • Those with pregnancy complications (e.g., preeclampsia, gestational diabetes, placenta previa),
  • Those with a history of chronic gastrointestinal disease (e.g., irritable bowel syndrome, Crohn's disease, ulcerative colitis),
  • Those with caffeine sensitivity or allergy,
  • Those with chronic pain syndrome or analgesic dependence,
  • Those who regularly consume coffee (≥2 cups per day),
  • Those who experienced intraoperative complications (e.g., bowel or bladder injury),
  • Those who could not comply with the study protocol.

结局指标

主要结局

Postoperative Pain

时间窗: 6 hour

The visual analog scale (VAS ) is a scale with different names at both ends on a 10 cm long vertical or horizon line. In this study, evaluation was made as "0 = no pain" and "10 = the most severe pain".

intestinal motility

时间窗: 24 hour

24 hour. The patient's bowel sounds will be listened to during the hours

intestinal motility

时间窗: 24 hour

24 hour. The patient's bowel sounds will be listened to during the hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HÜMEYRA YÜKSEL

Principal Investigator

TC Erciyes University

研究点 (2)

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