The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.
研究概览
简要总结
The purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.
详细描述
The outcome measure is patient discomfort as measured by a visual analogue scale.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing vaginal speculum examination between the ages of 18 and 50.
排除标准
- •Pregnancy.
- •Non-English speaking.
- •Using hormone therapy.
- •Active vulvar or vaginal lesion, infection or complaint.
- •Undergoing vaginal or vulvar procedure or biopsy.
- •History of chronic pelvic pain, interstitial cystitis or vulvar vestibulitis.
- •History of prior vulvar or vaginal surgical procedures.
结局指标
主要结局
Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.
时间窗: Immediate.
The outcome measure is a single measurement of pain using a 10-point visual analog scale entitled "Visual Pain Scale" immediately following speculum insertion. The scale is a continuous 10cm line with the minimum value of 0 (labeled "no pain") on the left side of the line, and a maximum value of 10 (labeled "worst pain") on the right side of the line. Higher scores represent more pain and a worse outcome. There are no additional measurements obtained, and patients will not be followed for study purposes thereafter.
次要结局
未报告次要终点
研究者
D. Ashley Hill, MD
Associate Director, Department of Obstetrics and Gynecology
AdventHealth