The Effect of Early Post-Cesarean Mobilization and Caffeine Consumption on Bowel Motility, Pain, and Psychological Well-being: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in postoperative Psychological Well-being after caesarean section within 24 hours from baseline
研究概览
简要总结
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.
详细描述
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.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
intervention group
They will be mobilized at 4 hours.They will consume Turkish coffee containing caffeine every six hours.
干预措施: caffeine consumption (Dietary Supplement)
Control Group
Women in the control group will receive routine intervention. They will be mobilized at 6 hours. Decaffeinated coffee will be served at 6-hour intervals.
干预措施: Decaffeinated coffee (Dietary Supplement)
结局指标
主要结局
Change in postoperative Psychological Well-being after caesarean section within 24 hours from baseline
时间窗: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Psychological Well-being will be assessed using Psychological Well-Being Scale. Based on the score obtained: 1.00-2.99 → Low psychological resilience, 3.00-4.30 → Moderate level, 4.31-5.00 → High psychological resilience.
Change in postoperative pain after caesarean section within 24 hours from baseline
时间窗: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Pain will be assessed using a 10 cm visual analogue scale. '0' means no pain, while '10' means unbearable pain. The assessment will be carried out at the start of the study, at 6-hour intervals, and at the end.
Change in postoperative Bowel Motility after caesarean section within 24 hours from baseline
时间窗: Starting point, after intervention at 6 hours, 12 hours, 18 hours and 24 hours
Bowel motility will be assessed using BFI. The Bowel Function Index (BFI) is a short and practical measure used to assess constipation, particularly in patients using opioids. It consists of three questions, each scored on a scale of 0 to 100. These scores are used to measure the degree of bowel dysfunction.
次要结局
未报告次要终点
研究者
Hafize Dağ Tüzmen
DOCTORAL PROFESSOR
KTO Karatay University