Effect of P6 Acupressure Stimulation on Shivering During Cesarean Section Under Epidural Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Incidence of resolution of shivering at 15 minutes
研究概览
简要总结
Shivering during a cesarean section can be quite uncomfortable for the patient as well as make it difficult for the anesthesiologist to obtain vital signs. The researchers will investigate whether or not applying pressure to the P6 acupressure point during a cesarean section can treat shivering. The hypothesis is that shivering will be alleviated with acupressure.
详细描述
The purpose of this study is to determine whether applying pressure to the left and right P6 acupoints can treat shivering in a patient undergoing a cesarean section. The hypothesis is that bilateral stimulation of P6 with pressure can stop or alleviate shivering.
The primary endpoint is resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.
The secondary endpoints include:
- Time to resolution of shivering
- Degree of patient-reported improvement in shivering
- Degree of practitioner-reported improvement in shivering
- Assessment of skin irritation and/or pain at the site of acupressure vs control
Patient information will be stored in a locked cabinet on labor and delivery, and that cabinet will be located in a T3-locked office. The link between subject ID and patient ID will be stored in a different office on labor and delivery, also under a T3 lock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a patient has to be classified as an American Society of Anesthesiology (ASA) physical status I, II, or III, laboring with an epidural catheter, and subsequently taken for a non-emergent cesarean section under epidural anesthesia with a core body temperature range of 35.5-38.0 degrees Celsius during shivering.
排除标准
- •ASA status 4 or higher
- •core body temperature lower than 35.5 or higher than 38.0
- •thyroid disease
- •systemic infection
- •emergent cesarean section,
- •a psychiatric, cognitive or medical condition that would compromise adherence to the protocol
结局指标
主要结局
Incidence of resolution of shivering at 15 minutes
时间窗: up to 15 minutes
Incidence of resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.
次要结局
- Time to resolution of shivering(up to 15 minutes)
- Degree of resolution of shivering(up to 15 minutes)
- Degree of practitioner-reported improvement in shivering(up to 15 minutes)
- Number of participants with skin irritation(up to 15 minutes)
- Number of participants with pain(up to 15 minutes)
研究者
Daniel Katz
Anesthesiologist, Associate professor
Icahn School of Medicine at Mount Sinai