A Prospective Trial Comparing Metal to Plastic Speculums for Patient Comfort
Completed
Conditions studied: Patient Comfort
In brief
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.
Key facts
- Study ID
- NCT01788124
- Run by
- St. John Health System, Michigan
- People needed
- 160
- Starts
- 2012-07-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2013-02-11
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- St John Macomb Oakland Hospital — Warren, Michigan, United States
Full record on ClinicalTrials.gov
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