A Randomized Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Patient Discomfort VAS
研究概览
简要总结
The purpose of this study is to evaluate the comfort of two type of speculums used during routine gynecologic exam. Your treatment and medical care will not change because you are participating in this study. Your doctor will continue to make all decisions regarding your proper treatment and care.
详细描述
Speculum examination is a common procedure in the gynecology clinic used for evaluation of numerous conditions such as vaginitis, and during cervical cytology screening (PAP smears). The speculum is inserted into the woman's vagina and used to keep the vaginal walls apart during exam and procedures. Each step of the examination with a speculum including insertion, manipulation during examination, and removal can cause discomfort for the patient. Fear of examination pain is considered one barrier to examination compliance. Any method to decrease discomfort during the exam would be considered beneficial to patient screening.
Typically two types of speculums are used in clinical practice, metal and plastic. There are advantages to both, and usage is usually predicated by physician preference. Previous studies have demonstrated a clear difference in patient comfort between metal speculums and newer dilating speculums such as the Vera scope (1). Clinical trials have also shown the benefit of using lubrication on metal speculums during routine exams (2). To date there are no clinical trails to examine the difference in patient comfort between metal and plastic bi-valve speculums.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any woman presenting to Great Lakes Obstetrics and Gynecology or Macomb Academic OB/GYN Clinic for a routine gynecological exam
- •Women ≥ 18 years of age
- •Women willing and able to give informed consent according to the guidelines established by the St John IRB
排除标准
- •Patients that can not or will not sign the informed consent document
- •Women whose English language skills are insufficient to understand the written informed consent or the post examination questionnaire.
- •Any woman for who use of a speculum is contraindicated.
- •Any woman with a condition that might alter pain perception
- •Current pain medication use
- •History of drug abuse
- •History of painful speculum examination
- •Menopausal women
- •Women who are pregnant or within 6 weeks of delivery
- •Women presenting with dyspareunia, vaginitis, vulvar pain or vulvar lesions
- •Women presenting for a vulvar, vaginal or uterine procedure.
- •Women who have had a previous abnormal PAP smear (Cervical Intraepithelial Neoplasia >1)
- •Women ≤ 18 years of age.
- •Women who have never had vaginal intercourse.
- •Women who have never had a speculum examination in the past
结局指标
主要结局
Patient Discomfort VAS
时间窗: up to one day post exam
. Patients presenting for routine gynecological examination will be randomized to either plastic or metal speculum arm. Patient discomfort will be assessed using a self administered visual analogue scale (VAS). Patient comfort between groups will be assessed
次要结局
未报告次要终点
研究者
Michael Shaw PhD
Research Coordinator
St. John Health System, Michigan