NCT06708169招募中不适用
Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of participants with intraoperative maternal shivering
研究概览
简要总结
The goal of this study is to learn about the effect of preemptive education on reducing intraoperative maternal shivering in elective cesarean delivery. The main question it aims to answer is:
Does preemptive education by anesthesiologists reduce intraoperative maternal shivering in elective cesarean delivery?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 19 years or older
- •Gestational age 37 weeks or above
- •Elective surgey
排除标准
- •Emergency surgery
- •Any sign of onset of labor
- •Difficulty with communication
- •Contraindications of spinal anesthesia
- •Pre-eclampsia
研究组 & 干预措施
Patients without preoperative education by anesthesiologists
No Intervention
Patients get minimal information about the surgical process and their questions will be answered by obstetrician.
Patients with preoperative education by anesthesiologists
Experimental
Patients get preemptive education about the whole process from anesthesia to recovery stage within 15 minute by anesthesiologists.
干预措施: preemptive education provided by anesthesiologists (Behavioral)
结局指标
主要结局
Number of participants with intraoperative maternal shivering
时间窗: From the moment the patient enters the operating room (0 minute) until leaving the operating room on the same day, expected to be up to 180 minutes.
Record when shivering occurred within the time frame
次要结局
- Intraoperative body temperature(0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after entering the operating room until the end of surgery.)
- Intraoperative pain (Numeric rating scale, NRS).(From the moment the patient enters the operating room (0 minute) until leaving the operating room on the same day, expected to be up to 180 minutes.)
- Spinal anesthesia level (dermatome)(From the intrathecal injection (0 minute) until at the end of surgery (0, 5, 10, 25, 40, 55, 75 minute, at the end of surgery))
- Post-operative spinal anesthesia level in recovery room(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
- Number of Participants with Post-operative shivering in recovery room(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
- Post-operative body temperature in recovery room(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
- Post-operative nausea and vomiting in recovery room (by questionnaire)(From the time the patient enters the recovery room (0 minute) until leaving the recovery room (0, 15, 30, 45 minute, at the time the patient leaves the recovery room))
- Patient's satisfaction by questionnaire(From the end of surgery until 24 hours after surgery)
- Pain (assessed by NRS) until post-operative day 1(At 6, 12, 18, 24 hours after the end of surgery)
- Analgesic dosage (Morphile miligram equivalents) until post-operative day 1(From the end of surgery until 24 hours after surgery)
- Obstetric quality of recovery until post-operative day 1(At 24 hours after surgery)
研究者
研究点 (1)
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