NCT01788124

A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort

A Randomized Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: St. John Health System, Michigan · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Patient Comfort

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2013-02-11
• Last updated: 2013-02-11

Locations

1 site across 1 country: United States