Will Negative Phrasing Create a Nocebo Effect During Epidural Placement When Compared to Positive Phrasing? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Max pain score during the epidural procedure
研究概览
简要总结
To discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure.
详细描述
The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. One script will contain the wording "Poke and a burn" prior to subcutaneous local anesthetic administration for the epidural placement and one will contain "this is numbing medication, which will make the rest of the procedure go easier". There will be no difference in the epidural placement, medications, or the rest of the script.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnancy
- •requesting an epidural for the first time
排除标准
- •previous epidural (either for labor or for surgery)
- •BMI greater than 40 kg/m^2
- •previous lumbar spine surgery
- •inability to speak English
- •a history of chronic pain or are on chronic opioids
- •a history of opioid drug abuse
结局指标
主要结局
Max pain score during the epidural procedure
时间窗: 1 hour
Maximum pain score will be measured using a single 11-point Numeric Rating Scale 0-10, where 0 is no pain and 10 is maximum imaginable pain.
次要结局
- Overall satisfaction during the epidural procedure(1 hour)